Co-Founder and ex-CEO of @AtaiBeckley NASDAQ : $ATAI. Passionate about building companies, mental health and biotech. Views are my own. No investment advice.
Berlin, Germany
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Great news and yet another significant step forward for psychedelic medicine!
Today, @atai_life and @BeckleyPsytech announced (very!) positive topline results from the long-awaited Phase 2b trial of a single dose of BPL‑003 (5-MeO-DMT) in 193 patients living with treatment-resistant depression (TRD).
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Thanks to @afdhelaziz at @Forbes for giving me the opportunity to tell the @atai_life story & outline our programs underway, to unlock new therapeutic options across #psychedelics, digital tech & beyond, towards our vision to heal #mentalhealth. $ATAI
forbes.com/sites/afdhelaziz/…
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1/🚨 Interesting and surprising animal data was just published in @Nature_NPJ on psilocybin’s geroprotective (lifespan extension) potential 🍄
→ +51% increase in fibroblast lifespan (in vitro)
→ Monthly "low-dose" psilocybin (5–15 mg/kg) doubled survival in aged mice
→ Preserved telomere length, reduced oxidative stress & cell senescence
No human data yet — but compelling first experimental evidence demonstrating that psilocybin impacts hallmarks of aging.
Full paper: nature.com/articles/s41514-0…
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Some exciting additional data from the $ATAI analyst call just now on the BPL-003 Phase 2b topline data release from earlier today:
1) Balanced demographics across arms (Slide 1)
2) Very encouraging response and remission rates based on only a SINGLE dose of BPL-003 (better than many 85mg doses of Esketamine/SPRAVATO) (Slide 2 and 4)
3) Good safety and tolerability profile and majority of patients were able to be discharged after 90 min (Slide 3)
Great work team @atai_life @BeckleyPsytech !
Great news and yet another significant step forward for psychedelic medicine!
Today, @atai_life and @BeckleyPsytech announced (very!) positive topline results from the long-awaited Phase 2b trial of a single dose of BPL‑003 (5-MeO-DMT) in 193 patients living with treatment-resistant depression (TRD).
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🇩🇪🍄Germany rarely takes the lead in (regulatory) innovation these days - so it’s encouraging to see the country where we founded $ATAI emerging as a thought leader when it comes to compassionate access programs with psychedelics!
In contrast to systems like that of Health Canada, where regulators serve as the decision-makers, the German program empowers licensed psychiatrists to determine whether a patient qualifies for inclusion.
Congrats @Henrik_Jung and @Gerd_Gruender!
psychedelicalpha.com/news/ge…
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"A Promising Depression Drug Works. Psychedelics Are Back."
Nice coverage of yesterday's groundbreaking BPL-003 Phase 2b results and the general positive regulatory momentum when it comes to psychedelics in @barronsonline by @joshnathankazis:
barrons.com/articles/atai-de…
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The last few years have been transformative for #psychedelic medicine. As we approach a new era in #mentalhealthcare, let's take a moment and remember our journey together. linkedin.com/pulse/reflectio…
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Given the escalating mental health crisis we unfortunately find ourselves in, I am confident that psychedelic drug developers and ultimately patients will greatly benefit from this new FDA pilot program. $ATAI $CMPS
Today, I am pleased to announce that companies may now submit statements of interest for participation in the Commissioner's National Priority Voucher pilot program, which offers drug developers enhanced communication throughout the development process and dramatically shortens review times. It's a common-sense approach to bring more cures to the American public faster, without compromising safety or quality. FDA.gov/CNPV
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#Psychedelics like #psilocybin are getting attention as tools to address the #mentalhealth crisis.
#ICYMI, our friends at @COMPASSPathway recently completed the largest trial of ANY PSYCHEDELIC EVER.
+ @atai_life has multiple ph2 compounds w/ more on the way.
That's progress.
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1/ Will big pharma M&A and licensing deals be the next major catalyst for psychedelics this year? Looming patent cliffs, huge cash piles & promising late-stage psychedelic assets say yes.
@LarsWilde and I had a closer look - Let’s dive in 🧵
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Important news for patients: #COMP360 #psilocybin P2b shows rapid & durable improvements in TRD. Congrats to @LarsWilde, Ekaterina Malievskaia, George Goldsmith & team, @COMPASSPathway & @atai_life. Hear my thoughts:
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I truly believe in the value of healthy competition to drive innovation, breakthroughs and excellence in biotech.
So thank you $GHRS and $MNMD for being formidable competitors over the last years. It pushed us at $ATAI to be even more laser-focused and obsessed to develop only the best possible options for patients who lack effective treatments today.
“Competition ignites passion, determination, and the pursuit of excellence.”
– Serena Williams
$ATAI
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Amazing news and renewed hope for people living with addiction and brain injury for whom nothing is working today! Great to see Texas leading the way in government supported R&D efforts with respect to Psychedelic medicine! I hope that other states and countries will follow suite, recognizing the tremendous therapeutic potential that Ibogaine holds! Grateful to @w_bryan_hubbard and @GovernorPerry for pushing this Ibogaine Initiative forward with passion, grit and dedication!
The $50 million appropriation will help fund FDA-approved clinical trials of ibogaine in partnership with a drug developer, who will assume all financial risk and regulatory responsibility for advancing the treatment through the clinical trial process. Texas retains a financial stake in any future dividends from successful drug development, which could be used to help fund access to ibogaine treatment for Texans in need.
prweb.com/releases/texas-lau…
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Thrilled to announce the closing of our latest fundraising round.
I want to thank our investors, our team at atai and our platform companies, and all who support our mission.
With everyone’s support, we can make the world a healthier place.
Read more: prn.to/38nH74j
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Edgy indeed, @hubermanlab! When we pioneered this space by starting $ATAI and $CMPS around 8 years ago, we were met with A LOT of skepticism from the traditional (neuropsychiatry) drug development community - we were literally laughed out of rooms.
It took a lot of focused hard work and generating high quality clinical trial data, to get us where we are today. And I am grateful to all patients that participated in these trials to help us as a society to advance the science of Psychedelics.
Given the recent positive regulatory and commercial momentum (FDA repeatedly calling Psychedelics a top-priority and Spravato on annual run rate of $1.7bn), I am SUPER optimistic for patients what the next 12 months will bring.
Psychedelics used to be so edgy to talk about. Now, federal tax $ is used to study their effects in mice & there are human clinical trials completed & ongoing. People are discussing psilocybin for longevity. MDMA & ibogaine likely to gain FDA approval soon. Things. Have. Changed.
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The @WSJ ‘s @david_wainer on BPL-003 today:
“Tsai and others believe the drug has the potential to generate more than $1 billion in annual revenue.
[…] Atai’s current sub-$1 billion market capitalization could prove to be a bargain.”
Yup.
wsj.com/health/pharma/psyche…
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A massive step today, and so much excitement for the work ahead of us. Joining @Nasdaq with so many innovative companies is truly an honor. What an incredible journey for the @atai_life team so far. Thanks to all who poured in heart and soul to get us to this point.
We can change things. A future where families, friends, parents, sons, and daughters that we love have access to the help that they need. It’s the only future we will accept. And today, that future is one day closer.
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1/12 - Today, we saw another Phase 2 trial success of a psychedelic interventional psychiatry approach.
Read on for the key data from the RE104 (5‑HT2A agonist) Phase 2 in PPD and how the data compares to Brexanolone and Zuranolone (both approved in PPD recently):
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Today, we announced positive Phase 1 topline results with @atai_life’s EMP-01, our proprietary formulation of R-MDMA, building on decades of research into MDMA as a potential treatment for mental health conditions. $ATAI
We are pleased to announce positive topline results from our Phase 1 EMP-01 (R-MDMA) study.
“We found differences in the subjective experience of R-MDMA in comparison to published reports involving racemic MDMA. If confirmed, these differences suggest that R-MDMA may have applicability in a broad array of mental health conditions,” said Dr. @SriniGRao, Chief Scientific Officer and Co-Founder of atai.
Full release: ir.atai.life/news-releases/n…
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My co-founder @C_Angermayer is speaking at @SALTConference in NY this week, raising awareness of the potential of #psychedelics to help curb the global mental health crisis. Excited to attend - inspirational speaker list!
salt.org/events/2021/new-yor…
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Another great piece - this time by @Bloomberg columnist @chrismbryant - on the recent data readouts and positive clinical and regulatory momentum in the psychedelic drug development space: bloomberg.com/opinion/articl…
$ATAI $CMPS
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🚨 Big news for psychedelic medicine
@FDA Commissioner @MartyMakary just called psychedelics a “top priority” for the agency.
That’s the clearest public signal yet that the FDA is ready to act fast—if the data supports it.
🧵
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Pleased to update that #FDA has given IND clearance for @atai_life’s #ketamine isomer PCN-101 (R-ketamine) for US based trials. Kicking off a US based drug-drug interaction study early this year for this promising compound with potential in #depression
atai.life/2022/01/12/atai-li…
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I’m thrilled to be able to share that our company EmpathBio has entered into a Memorandum of Understanding with Bionomics to assess the feasibility of a novel treatment regimen for PTSD using their two lead compounds.
Fantastic news!
Read more: prn.to/3uaui6i
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Next Monday, my co-founder @SriniGRao will give testimony alongside a panel of experts (incl Dr. Deborah Mash and @NolanRyWilliams) on the therapeutic potential of Ibogaine for OUD on behalf of the Kentucky Opioid Abatement Advisory Commission.
The Commission’s goal is to allocate up to $42 million over six years towards research into the treatment of OUD specifically looking into ibogaine.
You can tune into the hearing live on Monday 17 July at 2pm EST 👇
piped.video/watch?v=WuOpoy…
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Today, I’m excited to announce @atai_life ’s strategic investment into @Beckley_Psytech. There is no one-size-fits-all solution when treating mental health conditions, which is why we’re proud to expand our portfolio of #psychedelic compounds with prior clinical evidence with BPL-003 (IN 5-MeO-DMT) and ELE-101 (IV Psilocin). $ATAI
Thrilled to announce our strategic investment in and collaboration with @BeckleyPsytech , bringing two clinical-stage psychedelic assets into the atai mental health innovation platform.
Join the webcast with our executive team today at 8am ET today to learn more. edge.media-server.com/mmc/p/…
Full press release here: ir.atai.life/news-releases/n…
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The recent #COMP360 #psilocybin #depression data was game-changing. So we’re increasing our stake in @COMPASSPathway to 20.8% in a firm show of confidence. We invested when they started & believe in their strong future in #mentalhealth
See: bit.ly/atai-COMPASS-investme…
UPDATE: atai increases ownership in @COMPASSPathway to 20.8%. Demonstrating our strong confidence in COMPASS, its milestone P2b #COMP360 #psilocybin data & its future in #psychedelics #mentalhealth #innovation
See: bit.ly/atai-COMPASS-investme…
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It’s an honor to be named one of @BusinessInsider's 30 leaders under 40 transforming #healthcare in 2022.
None of this would have been possible without the dedication of the @atai_life team.
businessinsider.com/30-leade…
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Today I wrote to @samhsa to praise their new outlook on the potential of therapeutic #psychedelics
Collaboration is key in solving the #mentalhealth crisis and I’m excited to offer @atai_life as a resource and partner
Read my full statement ⬇️
Today, we applaud the leadership of the @HHS and @SAMHSA.
This week, our CEO @Flobrand sent a letter to @SAMHSA_Leader to express our support of her vision of a public-private federal task force to help guide the rollout of therapeutic #psychedelics.
This is progress!
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Encouraging new COMP360 (Psilocybin) data set from a clinical trial with Veterans living with severe TRD!
Small sample size and open label, still indicative and helpful for hypothesis generation how the Psilocybin re-dosing paradigm could look like in the real world.
Significant symptom reduction from baseline at all timepoints but MADRS scores increased especially after 6 months post dosing (though not stat sig)
• Month 6:
– 80% responded
– 50% in remission
• Month 9: effects began to wane
• Month 12:
– 40% maintained response
– 30% remained in remission
sciencedirect.com/science/ar…
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1/ AbbVie’s rumored $1bn psychedelic deal could spark a pharma land grab. @LarsWilde and I ranked 10 big pharma players most likely to follow suit - here’s who tops the list. 🧵
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BREAKING: Interventional psychiatry keeps accelerating 🚀
J&J just released Q2'25 sales for SPRAVATO®: $414 M worldwide (+53 % YoY; $366 M in US). That’s a ~$1.7 B annual run-rate, powered by growing physician & patient demand.
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A significant moment for ibogaine and for DemeRx as we announce the commencement of a Phase 1/2a clinical trial of ibogaine.
The opioid epidemic is a global tragedy. We need more tools in our arsenal.
Read more: prn.to/3t6yNOe
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.@jesse_yeji’s list of top #psychedelic medicine companies has been updated on @businessinsider w/ the latest rounds from @ATAI_life & @COMPASSPathway... Some friendly competition on our platform for the top spot ;)
cc: @jfberke, @Psych_Fin
businessinsider.com/how-much…
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Today, we announced @atai_life’s Q3 quarterly financials & update. Proud to report excellent momentum: 11 programs, 2 clinical trial initiations, 1 key readout in COMP360, promising interim RL-007 data & strong business development #mentalhealth
bit.ly/atai-Q321-Earnings
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#virtuallypsyched to participate on tomorrow’s panel on funding in #psychedelics medicine!
... and if you’ve not registered yet, use FLORIAN20 for a 20% discount!
See you there ;)
cc: @MicrodoseHQ
eventbrite.co.uk/e/virtual-p…
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We have founded atai in 2018 with the bold and deeply personal mission to transform mental health care. Since then, I have had the privilege of leading atai as CEO through numerous R&D, business development and financing milestones, including our IPO in 2021. It has been one of my life’s greatest honors to work alongside the exceptional talent in our team to build atai into what it is today. I am incredibly proud of what we have achieved together in service of mental health patients to date.
As atai enters the later stages of clinical development, I am preparing to hand over the reins to no-one better than my co-founder and atai’s Chief Scientific Officer, Srinivas. Starting June 1, Srini will take on the role of Co-CEO and together we’ll work on a planned transition through the end of this year when I will be stepping down as CEO.
This decision comes with the confidence that our mission to advance mental health care through innovative solutions will continue to thrive under Srini’s capable leadership. With almost 25 years of experience in biotech and pharma, before joining atai, he has served as Chief Executive, Scientific or Medical Officer at numerous companies. At atai, Srini's leadership has been instrumental in shaping our strategic direction and in driving the significant R&D advancements we've made to date.
I want to express my deepest gratitude to my wife Anne-Marie for always having my back during the last years of company building, my Co-Founders Christian, Srini and Lars, the entire atai team and board, our clinical trial participants, partners, investors and the whole ecosystem.
It is an exciting time for atai with great momentum across our programs and I am looking forward to bearing witness to the new heights and breakthroughs for mental health patients that atai can achieve in the years to come!
Q1 2024 financial results and corporate updates.
✅ Dosing is on track in our VLS-01 Phase 1b program
✅ Promising Phase 2 data from BPL-003 and COMP360
✅ Leadership transition. Current CEO and Co-founder @flobrand will step down as CEO by the end of this year, to be succeeded by Co-founder and current Chief Scientific Officer, Dr. @SriniGRao. This planned transition marks a new chapter in atai’s journey, positioning us for the later stages of clinical development.
Read the full press release here: ir.atai.life/news-releases/n…
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Great progress! Very grateful and proud of the @atai_life sciences team for their passion and hard work aiming to radically improve the lives of ~1bn people living with mental health conditions globally!
Today we shared our 2023 full year financial results and business highlights.
Our CEO @FloBrand commented: “In 2023, we demonstrated our continued commitment to transforming mental health care for those most in need. Much of our recent focus has centered on developing psychedelic-based therapies for depression that require two hours or less in a clinic. We believe that the combination of a short treatment time and durable efficacy has the potential to enable accessible and convenient interventional treatments at scale.”
Read the full press release: ir.atai.life/news-releases/n…
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Big update for @atai_life and platform company DemeRx IB! Initiating Phase 1/2a trial of ibogaine for treatment of opioid use disorder (OUD). New treatments of OUD will be crucial in solving the opioid crisis.
Press release: bit.ly/atai-DemeRx-Ph1-2a
Watch: vimeo.com/610218379
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🚨 Breaking: Compass Pathways’ COMP360 meets primary endpoint in Phase 3 for treatment-resistant depression — first large psychedelic trial ever to do so!
Efficacy: A SINGLE dose of 25mg psilocybin led to –3.6 MADRS vs placebo at 6 weeks (p<0.001).
Safety: Importantly, "No unexpected safety findings and no clinically meaningful imbalance in suicidal ideation between treatment and placebo arms."
Congrats to the entire @COMPASSPathway team!These are highly encouraging results that positions Compass well to benefit from the new FDA Commissioner’s National Priority Voucher program, which could reduce NDA review times from the standard 10–12 months to as little as 1–2 months.
Commercially, COMP360 is now nicely positioned to compete against SPRAVATO with a potentially more patient-friendly treatment paradigm. Spravato requires 10 clinic visits totaling approximately 20 hours, while COMP360 achieves similar effects with a SINGLE 6–8 hour in-clinic administration.
As it's something that comes up frequently in discussions lately, I plan to share some additional thoughts on the significant commercial potential and roll-out of psychedelics (including COMP360) later this week in a separate post together with @LarsWilde.
ir.compasspathways.com/News-…
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What’s happening in Ukraine is a tragedy of epic proportions. To offer our support, we’re donating $100k through atai Impact to @ICRC @SaveChildren @HelpAge & @LiberecoPHR to provide emergency relief & support the mental health of the #Ukrainian people #StandwithUkraine
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New academic Phase 2a study of DMT in TRD patients was just released in @npp_journal: While small n and open label, this is a very encouraging data set that supports the notion that DMT has the potential to be a rapid acting and durable antidepressant fitting into the existing short interventional psychiatry paradigm established by SPRAVATO.
See here for full paper: nature.com/articles/s41386-0…
Interesting interview with lead investigator @draulio: shows.acast.com/neuropsychop…
Details on atai’s buccal film DMT phase 2 study: ir.atai.com/news-releases/ne…
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Strong progress in Q2 at @atai_life
Company-wide cost optimization, prioritizing our clinical programs, non-dilutive debt financing of up to $175M & strong cash position of $312M lead to anticipated increased runway into 2025 w/ many expected PoC readouts over next 2 years $ATAI
Today we announced our Q2 2022 earnings:
- Extended runway into 2025
- $312m cash + up to $175m non-dilutive debt
- Reprioritized pipeline w/ focus on clinical programs
- Hit 4 key R&D milestones and many expected PoC readouts in next 2 years
ir.atai.life/news-releases/n…
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We’ve started dosing in our Phase 1b trial of VLS-01. Proud of our team for the swift progress made in these past months.
A staggering 100 million people globally suffer from depression that is treatment resistant, meaning that available treatments do not work for them. Through our VLS-01 program we are working hard to change that.
VLS-01 is being developed as a short duration, rapid-acting and durable antidepressant treatment intervention.
ir.atai.life/news-releases/n…
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🚀 Update on the ELE-101 Phase 1/2a study 🚀
Yesterday, I talked at HLTH Europe about how short-duration Psychedelics such as our development candidates BPL-003, VLS-01 and ELE-01 could potentially leverage the established Spravato paradigm of an approx. 2h in-clinic stay to drive patient access to these drug candidates if they are approved.
Today, I am excited to share encouraging initial data from Beckley Psytech’s ELE-101 (IV Psilocin) program. As the active metabolite of psilocybin, psilocin has the potential to offer a rapid onset, significantly shorter treatment duration, and reduced inter-subject variability compared to oral formulations of psilocybin.
Based on initial data from the Phase 1/2a study, ELE-101 showed a dose-proportional PK profile and reliably induced short-duration psychedelic experiences. The initial Phase 1 data further demonstrated that it was well tolerated with no observerved SAEs.
While the Phase 2a is a small patient sample, we look forward to getting an initial read on potential efficacy in this open label study.
Read the full release below.
📣 Exciting update on @BeckleyPsytech's Phase 1/2a trial of ELE-101 (IV psilocin) for major depression. Initial results from Phase 1 and first patients dosed in Phase 2a. Full press release: ir.atai.life/news-releases/n…
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GREAT session @gjurvetson and @FutureJurvetson! Sad I couldn’t make it in person!
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Delighted to share positive open label data from the BPL-003 Phase 2a study in TRD
Earlier this year we made a strategic investment in @Beckley Psytech and are thrilled with the progress the team has made. The data from the Phase 2a study is very encouraging as we await the results of the larger Phase 2b study anticipated later this year. With around half of TRD patients in remission three months after just a single dose of BPL-003 with effects lasting <2h on average, we are particularly excited about its antidepressant durability potential.
These results offer encouraging support for the two hour in-clinic treatment paradigm we are targeting with multiple assets for the treatment of #depression, including VLS-01, our oral transmucosal formulation of DMT.
Excited to announce initial results from @BeckleyPsytech's Phase 2a open label study of BPL-003 (intranasal 5-MeO-DMT) in patients who suffer from treatment-resistant depression (TRD).
The results offer encouraging support for a 2-hour psychedelic-based treatment in the clinic. In summary, the Phase 2a results of BPL-003 demonstrated:
1⃣. Rapid-acting relief: a single dose of BPL-003 demonstrated a rapid antidepressant response in over half of the patients, offering hope for the 100 million grappling with the burden of TRD globally.
2⃣.Durable antidepressant effect: 45% of patients were in remission 3 months after a single dose. This is the longest reported improvement following 5-MeO-DMT treatment in a clinical setting.
3⃣.Short treatment time: the acute effects of BPL-003 resolved within an average of less than 2 hours.
These results are encouraging as we look forward to the data from the larger Phase 2b study of BPL-003 in 225 TRD patients, anticipated in the second half of this year.
Read the full press release here: ir.atai.life/news-releases/n…
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Over the weekend, @InstitutAurora brought together leaders and advocates in the #mentalhealth space and reminded us of the importance of collaboration.
Honored to be there and to recognize @adamgazz for his efforts in neuroscience.
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🚨 BREAKING - @SecKennedy just stated that "[we are] working to ensure safe, science-based access [to psychedelic therapy] within 12 months."
Watch the video below:
Psychedelic therapies show real promise for veterans and others battling trauma.
We’re accelerating clinical trials at @US_FDA with urgency—and working to ensure safe, science-based access within 12 months. Some therapies can’t wait.
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MAJOR ANNOUNCEMENT:
I'm pleased to share @ATAI_life has acquired a majority share in Recognify Life Sciences, focused on developing a treatment for Cognitive Impairment associated with Schizophrenia (CIAS) - a damaging disorder that affects millions.
finance.yahoo.com/news/atai-…
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Congrats to team @atai_life for achieving this important milestone with VLS-01 (DMT)! 👏👏👏 SO proud and excited to see the first patient dosed with this differentiated short duration psychedelic and can't wait to see the results of the Phase 2 ELUMINA trial in TRD patients! globenewswire.com/news-relea…
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When we founded atai Life Sciences in 2018, mental health drug development was an afterthought for Big Pharma. Challenges such as subjective clinical endpoints, complex biology, and high failure rates pushed many pharma away. Meanwhile, patient demand skyrocketed, leaving a massive innovation gap and patients behind.
Over the last two years, the tide is fortunately turning. Bristol Myers Squibb’s $14B acquisition of Karuna Therapeutics and Johnson & Johnson $15B deal for Intra-Cellular Therapies signal a resurgence of interest. And in addition, private investments in biotechs active in mental health drug development have significantly increased (see graph in article).
It's encouraging to see the @WSJ and @david_wainer covering Psychedelics as a key innovation catalyst in mental health that is gaining traction. Given the number of Phase 2 and Phase 3 clinical trial readouts this year, the next 12 months will be super interesting to watch.
The past decade has proven that breakthroughs come from those willing to challenge the status quo. Great to see that investors and big pharma players are paying more and more attention to the huge unmet patient needs in mental health and making moves to again allocate significant amounts of capital to neuroscience given the progress made over the last years.
See here for the full article: wsj.com/tech/biotech/big-pha…
#mentalhealth #neurosciecne #psychedelics #drugdevelopment #BigPharma
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Interesting small exploratory study evaluating 10mg and 25mg doses of Psilocybin (provided by Usona institute) in 14 people living with Bipolar II Disorder (BD-II) 👇
🍄🚨🍄🚨 Another day, another cool preprint from our group:
An open-label, dose-escalation trial of psilocybin-assisted therapy for bipolar 2 depression
We enrolled individuals with #bipolar 2 (BD-II) currently experiencing a major #depressive episode. Participants must have had at least one unsuccessful medication trial of >6 weeks duration for BD-II over their lifetime. Four participants were on medications with potential #psilocybin interactions, which were tapered under psychiatric supervision to ensure clearance (≥5 half lives) before each administration. Psychiatric exclusions included current hypomania, history of psychotic disorder, moderate substance use disorder in the past 12 months, psychedelic use in the past six months and imminent risk of suicide.
In this open-label, single-arm dose-escalation pilot trial, 14 participants received 10 mg of psilocybin, followed by 25 mg if depressive symptoms persisted. As usual participants underwent psychotherapy before, during, and after psilocybin administration sessions and were proactively monitored for adverse events. Depression and quality of life were assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) and Quality of Life in Bipolar Disorder Questionnaire (QoL-BD), along with exploratory measures.
Following the 10 mg session, MADRS scores significantly improved at all timepoints (A21: -12.7 [2.7], n=14, p<0.001) with 4 participants (28.5%) meeting remission criteria (MADRS ≤ 6) at 21 days after the 10mg dose. Non-remitting patients were given the 25 mg dose per protocol. After the 25 mg session, MADRS scores improved from baseline (B21: -18.6 [3.1], n=9, p<0.001). Sustained improvements in MADRS scores were observed at the 90-day assessment compared to baseline (AB90: -14.3 [2.8], n=12, p<0.001); Hedges’ g=1.9. QoL-BD scores improved 21 days following both the 10 and 25 mg administration sessions (A21: 35.5 [9.4], p<.001; B21: 55.9 [10.9], p<.001) and at the 90-day assessment (AB90: 31.2 [10.2], p=0.004); Hedges’ g=1.6.
As expected, common adverse events included mild-to-moderate anxiety, nausea, and headache on dosing day. There were three notable adverse events: active suicidal ideation 37 days after an administration session, passive suicidal ideation 11 days after an administration session, and a hypomanic episode two weeks after an administration session.
The small sample size and open-label design warrant cautious interpretation. The placebo response likely explains some of the observed benefits. However, in line with previous findings, baseline expectancy was not associated with clinical outcomes - to the best of my knowledge no psychedelic trial has provided empirical evidence for a positive expectancy bias at this point.
Our results offer initial evidence that psilocybin therapy may be clinically beneficial in BD-II when administered under controlled conditions with a safety profile similar to studies in other patient populations.
Full preprint: tinyurl.com/52n6uv4t
🙏+♥️to all coauthors: @drdowneydoes @thebandlab @ellenbradshaw and many others from the @UCSFPsychiatry 's @TrPR_Program!
#psychedelic #trial #MentalHealthMonday #medicalinnovation
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Looking forward to speaking at @SlushHQ in Helsinki this week. You can catch my panel, “Psychedelics – The New Psychiatric Frontier”, on Wednesday.
#Slush2021 #psychedelics
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Honoured to feature in @endpts 20(+1) under 40. In truth, a massive team effort. Thanks to my co-founders @C_Angermayer, @LarsWilde & @SriniGRao; to @Nicole_DeFeudis for the interview; + to whole atai + platform team for making me look good day in day out.
endpts.com/the-201-under-40-…
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I wrote to @DEAHQ to support their increased aggregate production quota for #psychedelics.
I'm encouraged that the agency is prioritizing access to scheduled substances for clinical research in #mentalhealth.
Our CEO @flobrand recently wrote to the @DEAHQ in support of the agency’s proposal for increased access to #psychedelic compounds for clinical research.
A significant milestone bolsters our efforts in finding innovative solutions for #mentalhealth disorders.
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A coming of age moment for atai: Some reflections on our IPO by our dear friend Seth Miller linkedin.com/pulse/coming-ag… via @LinkedIn
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Today's launch of TryptageniX offers a glimpse of what’s next at @atai_life as we further expand our robust IP portfolio, using bioprospecting to develop NCEs and biosynthesis to optimize scalability of compounds.
bit.ly/atai-TryptageniX-laun…
Today we launched TryptageniX, collaborating with @CBTherapeutics, to take a bioprospecting approach to develop new chemical entities inaccessible through conventional chemical means - strengthening our growing IP portfolio & supply chain.
bit.ly/atai-TryptageniX-laun…
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Amid a busy week of news, I’m very happy to share positive preliminary Phase 1b data and our plans for an upcoming Phase 2 of VLS-01 (oral formulation of DMT).
Learn more via:
- Press release: globenewswire.com/en/news-re…
- Updated investor presentation: ir.atai.life/static-files/b9…
Today we announced positive initial results from Phase 1b of our VLS-01 program, a proprietary oral formulation of DMT we are developing for an estimated 100 million people suffering from treatment-resistant #depression. The results support the potential of VLS-01 as best-in-class: a patient-friendly, needle-free, 2-hour in-clinic treatment.
A robustly designed Phase 2 trial in 142 TRD patients is set to begin towards the end of this year.
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Great to see @Trevornoah and @michaelpollan discussing the potential of psychedelics on the @TheDailyShow! #mentalhealth
Psychedelics are more than just illicit drugs. @michaelpollan breaks it down.
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Huge congratulations to @RickDoblin and team at @MAPS on the publication of the Phase 3 top-line results from their latest MDMA Assisted Therapy trial for PTSD. Promising initial data - looking forward to the full publication in @NatureMedicine.
nytimes.com/2021/05/03/healt…
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And great to see @CathieDWood increase @ARKInvest's exposure to the tremendous potential that these therapeutic agents hold for patients: investing.com/news/company-n…
"A Promising Depression Drug Works. Psychedelics Are Back."
Nice coverage of yesterday's groundbreaking BPL-003 Phase 2b results and the general positive regulatory momentum when it comes to psychedelics in @barronsonline by @joshnathankazis:
barrons.com/articles/atai-de…
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As always very much worthwhile reading @HarryNeuro's perspectives on recent developments in the CNS field, including his reflections on the upcoming @COMPASSPathway ' COMP360 and @atai_life / @BeckleyPsytech's BPL-003 trial readouts.
And couldn't agree more with him and @Psyched_Alpha / @Josh__Hardman that "2025 is set to be a watershed year for the psychedelics field"! Important data readouts this year that will hopefully pave the way for better treatment options for people living with mental health conditions!
Looking forward to the next NeuroPerspective July Issue!
Click here to read the full note: linkedin.com/posts/harry-tra…
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At @Founders_Forum with @C_Angermayer today outlining the important role & vison of @atai_life in improving mental health and our plans to make a meaningful positive difference to the 1bn living with mental health disorders worldwide #mentalhealth #FFNYC #psychedelics #biotech
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Thrilled to announce that the first patient has been dosed in the Part 2 of the BPL-003 Phase 2a trial in patients living with treatment resistant depression!
While the first part of the study was evaluating BPL-003 as monotherapy, this second part will investigate whether BPL-003 could be a safe and effective adjunctive therapy in combination with SSRIs.
Subject to regulatory approval, findings from this part of the study could support broadening patient access to BPL-003 in the future.
📣 BPL-003 clinical trial progress
A few weeks ago, we announced the positive results from the BPL-003 Phase 2a study in patients with treatment resistant depression who were not on oral antidepressants (SSRIs). The first patient has now been dosed in the second part of the Phase 2a study, in patients who are on SSRIs, which could help to inform whether BPL-003 could be a safe and effective therapy in combination with SSRIs.
Read the full release here: ir.atai.life/news-releases/n…
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It’s an honor to be named one of @FortuneMagazine’s #40under40
Without the efforts of the @atai_life team, none of this would have been possible.
Thank you, team!
fortune.com/40-under-40/2022
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Positive data on #COMP360 keep coming – latest exploratory results show potential as adjunctive therapy, building on Ph2b monotherapy data last month. Excited to see how the Ph3 will shape up. Proud that @COMPASSPathway is part of the @atai_life journey
ir.compasspathways.com/news-…
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🚀Exciting news from The Centre of the Neuroscience of Psychedelics at @MassGeneralNews.
The atai Fellowship announces its first cohort of neuro-innovators!
Exciting update from atai Impact: The first cohort of the atai Fellows in Psychedelic at @MassGeneralNews are already hard at work!
Learn what these five promising researchers will be exploring in the years to come!
buff.ly/3PuDyNX
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We’re driving accelerated timelines for our compound RL-007, for Cognitive Impairment Associated with Schizophrenia, given promising interim Phase 2a data, with Recognify.
Press release: bit.ly/Recognify-Interim-Dat…
#schizophrenia #researchanddevelopment
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Making psychoactive compounds more efficacious, safer and more tolerable for our patients is absolutely central to our work, so I am thrilled to announce a new strategic partnership with oral film maker @IntelGenx.
Read more: bit.ly/2PYGI1A
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Thank you @Simone_Biles for reminding the world that #mentalheath IS health. We at @atai_life applaud her brave choice to speak out, paving the way for fans and wider community to do the same.
nbcnews.com/news/olympics/we…
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Today we announce the collaboration of our platform company Perception with Otsuka Pharmaceuticals. The teams will develop and commercialize PCN-101 (R-ketamine) in Japan, with the goal of providing new options to patients suffering from TRD.
Read more: prn.to/3rWqiF2
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The FDA just published 200+ Complete Response Letters (CRLs) - making drug-rejection rationales public for the first time to help developers learn & avoid repeat errors. Details: fda.gov/news-events/press-an…
You can download the CRLs here: open.fda.gov/apis/other/appr…
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Grateful to have been given the opportunity to share the @atai_life vision and mission at @SlushHQ and meet so many fascinating, like-minded start-up colleagues.
#Slush2021 #psychedelics #psychiatry #mentalhealth
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Grateful for your coverage of our VLS-01 Phase 1 results as well as our plans for progressing VLS-01 into a Phase 2 in TRD in @statnews today @elaineywchen and @megkesh ! statnews.com/2024/08/13/biot…
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Inspirational @hyberlin podcast with my dear friend and co-founder @C_Angermayer
Biotech, Psychopharmaka und Langlebigkeit sind seine Hauptthemen – sie faszinieren ihn und haben ihm bedeutende Erfolge beschert. Im Gespräch mit @ChristophKeese berichtet @C_Angermayer was ihn antreibt und wie ihm seine Spiritualität als Inspiration dient:linktr.ee/hy.co
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Time to “change your mind” - if you haven’t already done so 😉
History shows how hard it is to grasp paradigm shifts early, especially in biotech/pharma:
A decade ago, most analysts predicted cancer immunotherapy would peak at ~$5-10B annual revenues.
Today, the top three checkpoint inhibitors generate $41B+ annually.
I expect the same if not bigger smashing success for psychedelics.
Because in mental health, unfortunately, the addressable population is even larger: ~17 million Americans have cancer. But nearly 80 million suffer from depression, anxiety, trauma, or substance use disorders. And countless more suffer in silence.
And this number is only growing in our increasingly stress-inducing world.
I believe $ATAI will capture most of those revenues, due to a mix of commercial reasons ("2-hour-window"), patents, formulations, delivery methods & more.
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Congratulations team, this is an important milestone!
~7 million Americans live with generalized #anxiety disorder (GAD) and less than half will receive treatment. We need safer and more effective options for anxiety disorders like GAD.
Find out more 👇
#ICYMI: Last week, we announced positive results from our Phase 1 clinical trial of GRX-917 for generalized anxiety disorder (GAD).
Initiation of GRX-917 efficacy study is anticipated in H1 2023, with results expected in 2024.
ir.atai.life/news-releases/n…
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Congrats to @compasspathways on completing recruitment in Ph IIB study of Psilocybin for Treatment-Resistant Depression. Compass and @atai_life have a shared goal: developing more effective mental health treatments. Great news! compasspathways.com/psilocyb…
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👇Tune in!
Our management team will participate in the @HCWCO Neuro Perspectives conference on Thursday June 27.
Co-CEOs @SriniGRao and @flobrand will engage in a fireside chat which will be available on-demand from 7:00 am ET via the following link. journey.ct.events/view/9f686….
There will be a replay on the Investors section of our website under Events for 90 days.
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Some folks have asked us about the news of events at $SIVB so I want to clarify that $ATAI has no assets held at SVB. We wish those affected the very best.
#SVB #SiliconValleyBank
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This is a truly exciting industry-shaping event and great news for mental health patients!
Seven years ago, I co-founded atai Life Sciences with @C_Angermayer, @LarsWilde and @SriniGRao as a response to the growing mental health crisis. The goal was to bring psychedelics back into mainstream medicine - and to build a company that could lead this transformation with scientific rigor, patient-centricity, compassion and scale.
In this context, as a co-founder and shareholder of atai I couldn't be more thrilled to see @atai_life and @BeckleyPsytech joining forces to form atai Beckley - a true leader in short-acting, scalable psychedelic therapies with a highly competitive and differentiated pipeline.
Also great to see industry players @ferring and Adage Capital Partners investing and validating this transaction. This is great news for mental health patients who so urgently need and deserve better treatment options!
Looking forward to the BPL-003 (5-MeO-DMT) Phase 2b data readout this summer!
bloomberg.com/news/articles/…
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. @atai_life is taking a new approach to developing #mentalhealth treatments and bringing relief to the millions suffering worldwide.
This #WorldMentalHealthDay, join our mission to #healmentalhealth for everyone everywhere.
This #WorldMentalHealthDay, hear from neuroscientist, clinical psychologist, and our scientific advisor @heather_berlin, and join us in our mission to #healmentalhealth for everyone everywhere.
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Had a great chat with @superglaze of @fortune. Always humbling to share my personal journey and why we built @atai_life.
#mentalhealth #biotech
fortune.com/2022/12/05/flori…
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Thank you @AmberTongPW for covering and contextualizing today's encouraging data release from the BPL-003 (intranasal 5-MeO-DMT) Phase 2a open label study in TRD 🙏
endpts.com/atai-life-science…
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We’re proud to be an international team standing up for democracy, freedom & peace. Moved by the tragic events in #Ukraine, we’ve signed this call from @PeterKolchinsky et al for business leaders to economically disengage from Russian industry. medium.com/@BusinessLeadersF…
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Exciting to see growing momentum around the potential of psychedelics in neurodegenerative diseases like Parkinson’s. A frontier worth watching closely. Thanks for pointing us to this new small pilot study with psilocybin in PD patients @ChemWit
nature.com/articles/s41386-0…
#psychedelics #neuroscience #parkinsons #biotech #drugdevelopment
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10/ If you track the intersection of Big Pharma & psychedelic drug development, you’ll want the full breakdown and follow our substack for more analyses to come soon:
👉 open.substack.com/pub/brandf…
— end 🧵
$ATAI $CMPS $MNMD $GHRS
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It is my honor to announce @ATAI_life's collaboration with @MassGeneralNews’ new Center for the Neuroscience of Psychedelics.
Together, we hope to accelerate essential research and the development of targeted mental health treatments.
Read more here: prn.to/2YiZuBL
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End of last month @atai_life's Isabella Premoli, PhD presented pharmocodynamic qEEG data from the GRX-917 Phase 1 at the Society of Biological Psychiatry (SOBP) Annual Meeting held on April 27-29 in San Diego. In his newest blog post @SriniGRao summarizes key findings and highlights how we use qEEG as part of our biomarker approach in early clinical phases of CNS drug development. Check it out here: linkedin.com/pulse/grx-917-u…
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We’re proud to have supported @COMPASSPathway pioneering work from the very beginning. Can’t wait to see what comes next!
Congratulations to everyone at COMPASS🙌
A historic milestone by the @COMPASSPathway team!
@NEJM has published positive results from COMPASS’ phase 2b trial of COMP360 #psilocybin therapy for treatment-resistant #depression
Congratulations from everyone at atai 👏👏👏
compasspathways.com/compass-…
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Today, I am proud to announce @atai_life’s 2021 EOY & Q4 financial results, share successes from our first year as a public company and outline our many anticipated catalysts to come $ATAI #mentalhealth 1/2
Press release: bit.ly/atai-earnings
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Today we share our $atai Q1 2023 updates. We have achieved a lot over the last months - thanks to the @atai_life team, our shareholders, and the clinical trial participants and their loved ones who make our research possible.🙏
#mentalhealth #biotech #earnings
“Mental health conditions are among the leading contributors to the global burden of disease.” (WHO Dir-Gen). Yet >75% of #mentalhealth patients are not treated effectively.
Our $atai Q1 23 #earnings update demonstrates our commitment to #innovation.
Read the full PR here: lnkd.in/dMkQ8C7J
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Congrats to both @atai_life and @BeckleyPsytech - this is great news for patients and an important industry-shaping event forming a true leader in mental health innovation!
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Yesterday, Texas Governor Abbott signed Senate ‘Bill 2308’ into law to grant state matching funds for research of ibogaine.
It’s a big milestone in decades of psychedelics research to see a (state) government so publicly acknowledge the therapeutic potential of Ibogaine by allocating significant funds to thoroughly study and characterize this powerful compound so Ibogaine therapy can become an integral part of the healthcare system.
Congrats Amber, Marcus @vetsforvets, @NolanRyWilliams , @w_bryan_hubbard and the many more spearheading this initiative!
Texas @GovAbbot has signed HB 3717/SB 2308, cementing the largest state-funded psychedel!c research initiative in U.S. history. This is a turning point for how our country address veteran care and a bold step toward hope, healing, and solutions. 🙏
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As we continue to build our diverse platform, Recognify Life Sciences has announced its lead compound, RL-007, has received IND clearance to start its Phase 2 trial for Cognitive Impairment Associated with Schizophrenia.
Read more: prn.to/3t1dXA4
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SalA has prior evidence in humans, which we believe will lead to increased probability of success in clinical trials. Coupled with the unmet need in TRD, we believe Revixia has high potential – both as a commercial endeavour, and as an avenue for healing TRD patients.
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Thank you, @SAMHSA_Leader, for putting it so eloquently.
We also agree that “too many Americans are suffering from mental health and substance use issues… we must explore the potential of psychedelic-assisted therapies to address this crisis”
documentcloud.org/documents/…
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Thanks for having me on @CNBCClosingBell this week @wilfredfrost and @saraeisen. Always excited to share the atai story and advocate for greater focus on mental health treatments that have been underused and overlooked.
$atai #psychedelics #mentalhealth
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