MomsSpaghetti
1 week ago
atai Life Sciences Announces Positive Topline Results from Beckley Psytech’s BPL-003 (intranasal 5-MeO-DMT benzoate) Phase 2a Open-Label Study for Alcohol Use Disorder
https://ir.atai.life/news-releases/news-release-details/atai-life-sciences-announces-positive-topline-results-beckley
- A single dose of BPL-003, combined with relapse prevention therapy, produced meaningful and sustained reductions in alcohol use, with 50% of patients maintaining complete abstinence out to three months
- BPL-003 was well-tolerated with no serious or severe adverse events reported
NEW YORK and BERLIN, Jan. 28, 2025 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai” or “Company”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced positive topline results from Beckley Psytech’s Phase 2a open-label study of BPL-003 in 12 patients with moderate to severe alcohol use disorder (AUD). BPL-003 is a patent-protected synthetic intranasal formulation of 5-MeO-DMT benzoate designed to deliver rapid and durable treatment effects from a single dose with a short in-clinic treatment time. The results showed that a single dose of BPL-003, in combination with relapse prevention cognitive behavioral therapy, induced meaningful and sustained reduction in alcohol use and heavy drinking days (HDDs) in patients with moderate to severe AUD out to 12 weeks.
“We are encouraged by these exploratory results from Beckley Psytech, our strategic investment, which demonstrate the potential of short in-clinic psychedelic therapies to transform the treatment of substance use disorders,” stated Dr. Srinivas Rao, CEO and Co-founder of atai. “The high rates of sustained abstinence in this study are particularly promising given the significant challenges patients with alcohol use disorder face in achieving and maintaining abstinence. These findings add to the growing body of evidence supporting the potential of BPL-003 in treating serious mental health disorders. We look forward to the Phase 2b data readout of BPL-003 in treatment-resistant depression expected mid-year.”
The 12-week Phase 2a open-label study enrolled 12 patients with moderate to severe AUD and evaluated the safety, tolerability, pharmacodynamic effects and impact on alcohol use of a single dose of BPL-003, in combination with relapse prevention cognitive behavioral therapy (NCT05674929). The results demonstrated meaningful and sustained reductions in alcohol use following a single dose of BPL-003:
Mean number of alcohol units consumed per day decreased from 9.3 units to 2.2 units at Week 12
Mean percentage of HDDs, defined as consuming seven or more units of alcohol per day for women and nine or more units of alcohol per day for men, declined from 56% to 13% at Week 12
Mean number of abstinent days increased from 33% to 81% at Week 12
50% of the patients remained completely abstinent through the 12-week study
BPL-003 was shown to be well-tolerated with adverse events (AEs) being reported as mild or moderate and there were no serious or severe adverse events reported. Most patients were assessed as ready for discharge within approximately two hours.
Beckley Psytech plans to evaluate future development options for BPL-003 in substance use disorders and anticipates reporting additional clinical data from this study in publications and conferences in 2025.
About Alcohol Use Disorder (AUD)
AUD is a medical condition characterized by an impaired ability to stop or control alcohol use despite adverse social, occupational, or health consequences. The World Health Organization estimates that around 400 million people suffer with AUD worldwide, with around 3 million deaths each year attributed to the harmful use of alcohol. Currently available pharmacological treatment options are not very effective and some people with alcohol use disorder who wish to abstain from, or reduce, alcohol consumption do not achieve their treatment goal with currently approved treatment options. This contributes to an unmet need for more effective medical treatments.
About BPL-003
BPL-003 is Beckley Psytech’s patent-protected synthetic intranasal 5-MeO-DMT benzoate formulation, designed to deliver rapid and durable effects from a single dose, with a short time in clinic. PL-003 is being investigated for treatment resistant depression (TRD) and for alcohol use disorder (AUD). In a Phase 2a study TRD study, a single 10mg dose of BPL-003 produced a rapid antidepressant response in 55% of patients at Day 1, with 55% of patients in remission at Day 29 and 45% in remission at Day 85. BPL-003 demonstrated a short treatment duration, with patients deemed ready to be discharged within an average of less than two hours. Topline Phase 2b data are anticipated mid-2025.
About Beckley Psytech Ltd
Beckley Psytech Ltd. is a private clinical-stage biopharmaceutical company dedicated to improving the lives of people with neuropsychiatric disorders through the development of rapid-acting, short-duration psychedelic medicines. In January 2024, atai made a strategic investment in Beckley Psytech, resulting in a 35.5% ownership stake and 1:1 warrant coverage at a 30% premium on the primary issuances. atai holds a time-limited right of first refusal on a future sale of the company and an indefinite right of first negotiation for BPL-003 and ELE-101. atai and Beckley Psytech also agreed to collaborate on digital therapeutics, commercial and market access activities in preparation for future potential commercialization.
About atai Life Sciences
atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. The Company was founded in response to the significant unmet need and lack of innovation in the mental health treatment landscape. atai is dedicated to developing novel, evidence-based therapeutics to treat depression, anxiety and other mental health disorders. atai's vision is to heal mental health disorders so that everyone, everywhere can live a more fulfilled life. For more information, please visit www.atai.life.
MomsSpaghetti
3 months ago
atai Life Sciences Reports Third Quarter 2024 Financial Results and Provides Corporate Updates
November 13, 2024
Download PDF
- The United States Food and Drug Administration cleared the investigational new drug application for VLS-01 (buccal film DMT); atai expects to initiate a Phase 2 study in treatment-resistant depression patients around YE’24
- Remain on track to initiate a Phase 2 study of EMP-01 (oral R-MDMA) in social anxiety disorder patients around YE’24
- Cash, marketable securities, and committed term loan funding expected to fund operations into 2026
NEW YORK and BERLIN, Nov. 13, 2024 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai” or “Company”), (NASDAQ: ATAI) (“atai” or “Company”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced third quarter 2024 financial results and provided corporate updates.
“As we approach the end of 2024, we continue to see progress and momentum across our pipeline, both with our wholly owned programs and strategic investments,” stated Dr. Srinivas Rao, Co-Chief Executive Officer and Co-founder of atai. “We are on track to initiate Phase 2 trials for VLS-01 and EMP-01 around year-end and we look forward to topline Phase 2b data from Beckley Psytech’s BPL-003 in the second quarter of 2025. Our team is focused on executing these trials with the utmost scientific rigor and is driven by our goal of being the leader in developing new psychedelic treatment options to mental health patients in need of innovative, safe and effective solutions.”
Recent Clinical Highlights
VLS-01: N,N-dimethyltryptamine (DMT) for Treatment-Resistant Depression (TRD)
VLS-01 is a proprietary oral transmucosal film formulation of DMT applied to the buccal surface designed to fit within a two-hour in-clinic treatment paradigm.
The United States Food and Drug Administration (FDA) cleared the investigational new drug (IND) application for VLS-01, allowing the Company to proceed with its plans to initiate a randomized, double-blind, placebo-controlled Phase 2 study to assess the safety, efficacy and durability of response of repeated doses of VLS-01 buccal film in patients with TRD.
The Phase 2 study is expected to initiate the study in U.S. around year-end 2024.
EMP-01: R-enantiomer of 3,4-methylenedioxy-methamphetamine (R-MDMA) for Social Anxiety Disorder (SAD)
EMP-01 is an oral formulation of R-MDMA that demonstrated a unique, dose-dependent subjective effect profile in a Phase 1 trial that was generally found to be more similar to classical psychedelics than to racemic MDMA.
atai expects to initiate an exploratory, randomized, double-blind, placebo-controlled Phase 2 study to assess the safety, tolerability and efficacy of EMP-01 in adults with SAD around year-end 2024.
SAD is an area of high unmet medical need with approximately 18 million people in the U.S. diagnosed in the past year and no novel molecules approved in over two decades.
IBX-210: Intravenous (IV)-Ibogaine for Opioid Use Disorder (OUD)
IBX-210 is a novel IV formulation of ibogaine, which is an indole alkaloid with potential for clinical benefit for substance use disorder
Completed productive FDA pre-IND meeting to initiate discussions and alignment on a modern ibogaine IND.
atai plans to run additional non-clinical studies prior to launching a Phase 1b study.
Novel 5-HT2A Receptor Agonists
Discovery program to identify novel, non-hallucinogenic 5-HT2AR agonists for TRD using artificial intelligence (AI)/machine learning (ML)-informed drug design and medicinal chemistry.
Presented data at the Society for Neuroscience (SfN) annual meeting aimed to show that these compounds are promising chemical starting points for new analogs with further improved 5-HT2AR vs. 5-HT2BR agonist selectivity that maintain translational antidepressant-like activity with potential for non-hallucinogenic effects.
RL-007: Pro-Cognitive Neuromodulator for Cognitive Impairment Associated with Schizophrenia (CIAS)
RL-007 is an orally bioavailable compound that has demonstrated pro-cognitive effects in multiple pre-clinical and clinical studies, including two Phase 1 and two Phase 2 trials.
The ongoing Phase 2b study is evaluating 20mg and 40mg of RL-007 vs. placebo in patients living with CIAS. Topline results are expected mid-2025.
Recent Corporate Updates
Completed the acquisition of IntelGenx Corp.
IntelGenx is a drug delivery company focused on the development and manufacturing of novel oral thin film products for the pharmaceutical market and manufactures VLS-01 (buccal film DMT).
Neither equity nor cash from the Company was used to acquire IntelGenx.
Anticipated Upcoming R&D Catalysts
H2’24
VLS-01 TRD: Phase 2 initiation (around YE’24)
EMP-01 SAD: Phase 2 initiation (around YE’24)
BPL-003 alcohol use disorder (AUD): Phase 2a topline open-label data
ELE-101 major depressive disorder (MDD): Phase 2a topline open-label data
2025
BPL-003 TRD: Phase 2b topline data (Q2’25)
RL-007 cognitive impairment associated with schizophrenia (CIAS): Phase 2b topline data (mid’25)
VLS-01 TRD: Phase 2 topline data (around YE’25)
EMP-01 SAD: Phase 2 topline data (around YE’25)
Consolidated Financial Results
Cash, cash equivalents, and short-term securities (primarily US treasuries and government agency securities): As of September 30, 2024, the Company had cash, cash equivalents, restricted cash and short-term securities of $101.0 million compared to $154.2 million as of December 31, 2023. The decrease of $53.2 million was primarily driven by $58.1 million net cash used in operating activities, $10.0 million for the Beckley Psytech investment, and $7.7 million investment to advance our programs; partially offset by $16.1 million in proceeds from the partial sale of our ADSs holdings in Compass Pathway, and $5.0 million in proceeds from our committed term loan with Hercules Capital, Inc. The Company expects its cash, short-term securities, public equity holdings, and committed term loan facility to be sufficient to fund operations into 2026.
Research and development (R&D) expenses: R&D expenses were $12.4 million for the three months ended September 30, 2024, as compared to $13.3 million for the same prior year period. The year-over-year decrease of $0.9 million was primarily attributable to a decrease of $2.7 million in R&D personnel-related expenses, partially offset by an increase of $1.7 million in program-specific expenses. Within program-specific expenses, the increase was primarily driven by additional clinical trial expenses in the current year. The Company is anticipating R&D spend to increase as its R&D programs progress into later stage clinical trials.
General and administrative (G&A) expenses: G&A expenses for the three months ended September 30, 2024, were $10.3 million as compared to $13.6 million in the same prior year period. The year-over-year decrease of $3.3 million was primarily attributable to a $3.5 million decrease in personnel-related expenses and administrative costs. The Company expects the reduction in G&A spend over prior years to continue.
Net income (loss): Net loss attributable to stockholders for the three months ended September 30, 2024, was $26.3 million, which included $2.0 million of non-cash change in fair value of notes receivables and other investments and $5.0 million of non-cash share-based compensation. Net income attributable to stockholders for the three months ended September 30, 2023 was $44.2 million, which included a $69.0 million non-cash change in fair value of other investments related to an accounting change of our Compass Pathways plc investment and $8.3 million of non-cash share-based compensation.
About atai Life Sciences
atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders and was founded as a response to the significant unmet need and lack of innovation in the mental health treatment landscape. atai is dedicated to efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines to achieve clinically meaningful and sustained behavioral change in mental health patients. atai's vision is to heal mental health disorders so that everyone, everywhere can live a more fulfilled life. For more information, please visit www.atai.life.
MomsSpaghetti
3 months ago
atai Life Sciences Reports Third Quarter 2024 Financial Results and Provides Corporate Updates
https://ir.atai.life/news-releases/news-release-details/atai-life-sciences-reports-third-quarter-2024-financial-results
- The United States Food and Drug Administration cleared the investigational new drug application for VLS-01 (buccal film DMT); atai expects to initiate a Phase 2 study in treatment-resistant depression patients around YE’24
- Remain on track to initiate a Phase 2 study of EMP-01 (oral R-MDMA) in social anxiety disorder patients around YE’24
- Cash, marketable securities, and committed term loan funding expected to fund operations into 2026
NEW YORK and BERLIN, Nov. 13, 2024 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai” or “Company”), (NASDAQ: ATAI) (“atai” or “Company”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced third quarter 2024 financial results and provided corporate updates.
“As we approach the end of 2024, we continue to see progress and momentum across our pipeline, both with our wholly owned programs and strategic investments,” stated Dr. Srinivas Rao, Co-Chief Executive Officer and Co-founder of atai. “We are on track to initiate Phase 2 trials for VLS-01 and EMP-01 around year-end and we look forward to topline Phase 2b data from Beckley Psytech’s BPL-003 in the second quarter of 2025. Our team is focused on executing these trials with the utmost scientific rigor and is driven by our goal of being the leader in developing new psychedelic treatment options to mental health patients in need of innovative, safe and effective solutions.”
Recent Clinical Highlights
VLS-01: N,N-dimethyltryptamine (DMT) for Treatment-Resistant Depression (TRD)
VLS-01 is a proprietary oral transmucosal film formulation of DMT applied to the buccal surface designed to fit within a two-hour in-clinic treatment paradigm.
The United States Food and Drug Administration (FDA) cleared the investigational new drug (IND) application for VLS-01, allowing the Company to proceed with its plans to initiate a randomized, double-blind, placebo-controlled Phase 2 study to assess the safety, efficacy and durability of response of repeated doses of VLS-01 buccal film in patients with TRD.
The Phase 2 study is expected to initiate the study in U.S. around year-end 2024.
EMP-01: R-enantiomer of 3,4-methylenedioxy-methamphetamine (R-MDMA) for Social Anxiety Disorder (SAD)
EMP-01 is an oral formulation of R-MDMA that demonstrated a unique, dose-dependent subjective effect profile in a Phase 1 trial that was generally found to be more similar to classical psychedelics than to racemic MDMA.
atai expects to initiate an exploratory, randomized, double-blind, placebo-controlled Phase 2 study to assess the safety, tolerability and efficacy of EMP-01 in adults with SAD around year-end 2024.
SAD is an area of high unmet medical need with approximately 18 million people in the U.S. diagnosed in the past year and no novel molecules approved in over two decades.
IBX-210: Intravenous (IV)-Ibogaine for Opioid Use Disorder (OUD)
IBX-210 is a novel IV formulation of ibogaine, which is an indole alkaloid with potential for clinical benefit for substance use disorder
Completed productive FDA pre-IND meeting to initiate discussions and alignment on a modern ibogaine IND.
atai plans to run additional non-clinical studies prior to launching a Phase 1b study.
Novel 5-HT2A Receptor Agonists
Discovery program to identify novel, non-hallucinogenic 5-HT2AR agonists for TRD using artificial intelligence (AI)/machine learning (ML)-informed drug design and medicinal chemistry.
Presented data at the Society for Neuroscience (SfN) annual meeting aimed to show that these compounds are promising chemical starting points for new analogs with further improved 5-HT2AR vs. 5-HT2BR agonist selectivity that maintain translational antidepressant-like activity with potential for non-hallucinogenic effects.
RL-007: Pro-Cognitive Neuromodulator for Cognitive Impairment Associated with Schizophrenia (CIAS)
RL-007 is an orally bioavailable compound that has demonstrated pro-cognitive effects in multiple pre-clinical and clinical studies, including two Phase 1 and two Phase 2 trials.
The ongoing Phase 2b study is evaluating 20mg and 40mg of RL-007 vs. placebo in patients living with CIAS. Topline results are expected mid-2025.
Recent Corporate Updates
Completed the acquisition of IntelGenx Corp.
IntelGenx is a drug delivery company focused on the development and manufacturing of novel oral thin film products for the pharmaceutical market and manufactures VLS-01 (buccal film DMT).
Neither equity nor cash from the Company was used to acquire IntelGenx.
Anticipated Upcoming R&D Catalysts
H2’24
VLS-01 TRD: Phase 2 initiation (around YE’24)
EMP-01 SAD: Phase 2 initiation (around YE’24)
BPL-003 alcohol use disorder (AUD): Phase 2a topline open-label data
ELE-101 major depressive disorder (MDD): Phase 2a topline open-label data
2025
BPL-003 TRD: Phase 2b topline data (Q2’25)
RL-007 cognitive impairment associated with schizophrenia (CIAS): Phase 2b topline data (mid’25)
VLS-01 TRD: Phase 2 topline data (around YE’25)
EMP-01 SAD: Phase 2 topline data (around YE’25)
MomsSpaghetti
3 months ago
Christian AngermayerChristian Angermayer • Following • Following Founder bei Apeiron Investment GroupFounder bei Apeiron Investment Group 1d •
1 day ago
One thing which seems to be a given under President Trump: hashtag#Biotech will profit.
Reasons are:
· a general deregulation strategy the new administration will implement,
· geopolitical tensions should calm down, and
· interest rates will fall further.
This should all lead to a renaissance of (small cap) biotech stocks.
You all know my conviction both in psychedelics as promising compounds for various mental health issues, and especially in atai Life Sciences.
With all "Big 5" on its platform – Psilocybin/Psilocin, DMT, 5-MeO-DMT, R-MDMA and Ibogaine – atai is imo the undisputed leader in the field and offers tremendous upside potential.
So far, 2024 has not been kind to psychedelics stocks. There are many reasons, most of them ‘unjustified’ imho:
· In times of uncertainty and stress, investors adopt a ‘risk-off’ mentality and don’t seek exposure to especially innovative companies that are pursuing novel approaches and pushing the envelope.
· The psychedelic treatment paradigm is indeed novel. It is not ‘pop a pill a day’ to put a band-aid over your struggles. But it aims to get to the root cause of a person’s trauma and help people truly get better.
· Because of this difference in approach, I know that many investors have particular doubts about the rapid commercial success of psychedelic treatments once they are potentially approved. They cannot yet see the transformative potential psychedelic-assisted therapy offers for patients. I believe that if you offer outstanding value and outcomes, you will be paid accordingly. My own early discussions with insurance companies confirm my general view on the topic of reimbursement.
· Lykos failed. Big time. The FDA rejected their application for MDMA as treatment for PTSD. Many investors interpreted this is a general hesitation of the FDA towards psychedelics. However, MDMA (which is not even itself a psychedelic in the core definition) was NOT rejected per se, but the specific, poor data set provided by Lykos Therapeutics was. I believe that MDMA is in fact a promising drug with tremendous therapeutic potential for patients with severe mental health issues. And atai has a novel, patent protected version going into Phase 2. Hence, if it all, then the Lykos failure has proven the atai model of professional, for-profit medical drug development, based on strong patent positions.
All those hesitations and doubts should vanish in a generally more positive market, especially since the Trump campaign has been outspokenly positive about psychedelics.
Hence, please check out my blog post from earlier this year for all reasons why I believe atai deserves a closer look:
https://lnkd.in/gws78cV9
The time for hashtag#psychedelics is NOW. I am absolutely certain of this.
MomsSpaghetti
8 months ago
atai Life Sciences Announces Update on Beckley Psytech’s Phase 1/2a Trial of ELE-101 (IV Psilocin) for Major Depressive Disorder, with Initial Results from Phase 1 and First Patients Dosed in Phase 2a
Thu, Jun 20, 2024, 7:00 AM EDT6 min read
https://finance.yahoo.com/news/atai-life-sciences-announces-beckley-110000192.html
atai Life Sciencesatai Life Sciences
ELE-101 is a patent-protected, synthetic formulation of psilocin, designed to offer the therapeutic benefits of psilocybin in a more consistent, controllable, and shorter treatment paradigm of approximately two hours.
The Phase 2a part of the study will evaluate the safety, tolerability, subjective effects, and efficacy of a single intravenous (IV) dose of ELE-101 in 6-12 participants with Major Depressive Disorder (MDD). Results are expected in H2 2024.
The dose for Phase 2a was selected using preliminary pharmacokinetic (PK) and pharmacodynamic (PD) data from the Phase 1 randomized, double-blind, placebo-controlled, single ascending dose part of the study of ELE-101 in healthy participants, which showed that it was well-tolerated with no serious adverse events. ELE-101 showed a dose-proportional PK profile and a reliable induction of short-duration psychedelic experiences.
NEW YORK and BERLIN, June 20, 2024 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai” or “Company”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced an update on Beckley Psytech’s Phase 1/2a trial of ELE-101 (NCT05434156) for people living with MDD, with initial results from Phase 1 and the dosing of the first patients in the Phase 2a part of the study.
ELE-101, a patent-protected IV formulation of psilocin, has been designed to provide consistent and controllable drug delivery in patients with neuropsychiatric conditions. 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. This could enhance convenience and therapeutic outcomes for patients with depression while reducing the resource burden on healthcare systems.
The open-label Phase 2a part of the study will evaluate the safety, tolerability, subjective effects, and efficacy of a single IV dose of ELE-101 in 6-12 patients diagnosed with MDD. Patients will be assessed at various time points in the study for up to three months after dosing, with results expected in H2 2024.
The dose was selected using preliminary PK/PD data from the Phase 1 part of the study, a randomized, double-blind, placebo-controlled, single ascending dose study of ELE-101 in healthy participants. Initial data from Phase 1 supports the differentiated profile of ELE-101, showing that ELE-101:
Was well-tolerated with no serious or severe adverse events (AE) reported, and an AE profile which is consistent with other compounds in this class.
Demonstrated a dose-proportional PK profile, leading to reduced inter-subject variability compared to oral psilocybin.
Induced high-intensity, short-duration psychedelic experiences, suggesting a potential treatment time of approximately two hours in the clinic. If validated in further studies, these findings could support the development of a scalable treatment model similar to the established paradigm of Spravato®, an esketamine nasal spray for treatment-resistant depression.
Full data from the Phase 1 study is expected to be published at a later date.
Commenting on the news, Dr Srinivas Rao, Co-CEO of atai said: “The data so far on ELE-101 indicates its potential as a promising candidate for treating depression. The consistent dose delivery and dose-proportional pharmacokinetic profile are particularly encouraging, as this could reduce variability among patients. At atai we are building a pipeline of short-duration psychedelics that target in-clinic treatments of approximately two hours. In addition to ELE-101, we believe Beckley Psytech’s lead candidate, BPL-003 (an intranasal 5-MeO-DMT), and our VLS-01 (an oral transmucosal formulation of DMT) could also fit this model.”
About atai Life Sciences
atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders and was founded as a response to the significant unmet need and lack of innovation in the mental health treatment landscape. atai is dedicated to efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines to achieve clinically meaningful and sustained behavioral change in mental health patients. atai's vision is to heal mental health disorders so that everyone, everywhere can live a more fulfilled life. For more information, please visit www.atai.life.
About Beckley Psytech
Beckley Psytech is a private clinical-stage biopharmaceutical company focused on improving the lives of people with neuropsychiatric disorders through the development of rapid-acting, short-duration psychedelic medicines. In January 2024, atai made a strategic investment in Beckley Psytech, resulting in a 35.5% ownership stake and 1:1 warrant coverage at a 30% premium on the primary issuances. atai holds a time-limited right of first refusal on a future sale of the company and an indefinite right of first negotiation for BPL-003 and ELE-101. atai and Beckley Psytech also agreed to collaborate on digital therapeutics, commercial and market access activities in preparation for future potential commercialization.
MomsSpaghetti
10 months ago
atai Life Sciences Announces Positive Initial Results from Beckley Psytech’s Phase 2a Open Label Study of BPL-003 (Intranasal 5-MeO-DMT) in Treatment Resistant Depression
https://www.globenewswire.com/news-release/2024/03/27/2853041/0/en/atai-Life-Sciences-Announces-Positive-Initial-Results-from-Beckley-Psytech-s-Phase-2a-Open-Label-Study-of-BPL-003-Intranasal-5-MeO-DMT-in-Treatment-Resistant-Depression.html
- A single dose of BPL-003 demonstrated a rapid and durable antidepressant effect in TRD patients, with 45% of patients in clinical remission at week 12
- 55% of patients achieved a clinical response on the day after dosing and this rate of response was maintained at week 4 and week 12
- BPL-003 showed a good safety profile and was well-tolerated with no serious adverse events reported
- Acute effects resolved on average in less than two hours, highlighting BPL-003’s potential to fit within the Spravato® two hour in-clinic treatment paradigm
- Phase 2b study of BPL-003 in 225 TRD patients is underway with top-line results expected in H2 2024
NEW YORK and BERLIN, March 27, 2024 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai” or “Company”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced positive initial results from Beckley Psytech’s Phase 2a open label study of BPL-003 in Treatment Resistant Depression (TRD), a condition that affects approximately 100 million people worldwide.
BPL-003 is a novel, synthetic, patent-protected benzoate salt formulation of 5-MeO-DMT (mebufotenin) administered intranasally. Initial results demonstrated that a single 10mg dose of BPL-003 was well-tolerated and resulted in a rapid onset and durable antidepressant effect in patients living with TRD.
The open-label Phase 2a study investigated the safety, tolerability and efficacy of a single 10mg dose of BPL-003 alongside psychological support in patients with moderate-to-severe TRD who were not taking concomitant antidepressants. 12 subjects were dosed, and 11 met the criteria for per-protocol analysis1. Patients were followed for 12 weeks post-dosing, with assessments conducted at multiple points throughout the study. Efficacy was assessed using the Montgomery–Åsberg Depression Rating Scale (MADRS).
Initial analysis showed that a single dose of BPL-003 induced a rapid antidepressant response2 in 55% of patients on the day after dosing. The antidepressant effect was durable, with a 55% response rate maintained at week 4, which continued to week 12. There were 55% of patients in remission3 at week 4 and 45% in remission at week 12. These findings represent the longest known follow-up of depression outcomes in a clinical study of 5-MeO-DMT.
BPL-003 showed a good safety profile and was well tolerated. Adverse events (AEs) were predominantly mild or moderate and the most common AEs (>10%) were nasal discomfort, headaches, nausea and vomiting, broadly consistent with Phase 1 findings. No serious AEs were reported.
Acute effects resolved on average in less than two hours. These data suggest that BPL-003 could offer a shorter in-clinic treatment time when compared to other psychedelic treatments currently in development.
Commenting on the results, Florian Brand, Chief Executive Officer and Co-Founder of atai Life Sciences said: "We are thrilled with the progress the Beckley Psytech team has made on the BPL-003 program. The positive data from the Phase 2a study is highly 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 in this study, we are particularly excited about its antidepressant durability potential. The results indicate that BPL-003 could offer a scalable, single-dose administration within the two hour in-clinic treatment paradigm successfully established by Spravato®.”
A Part 2 extension of this Phase 2a open label study is now enrolling patients with TRD who are on stable doses of oral antidepressants to assess the safety and efficacy of BPL-003 co-administration (NCT05660642).
A randomized, quadruple-masked, controlled Phase 2b study of BPL-003 is currently underway (NCT05870540). The study is investigating the effects of a single 12mg or 8mg dose of BPL-003 against a sub-perceptual dose of 0.3mg in 225 patients with TRD. Efficacy will be assessed by masked raters using the MADRS scale at several time points with the primary endpoint at week 4 and final assessment at week 8. Top-line results are expected in H2 2024.
1 Prior to data analysis, one subject (from total of 12 patients) was determined not to meet multiple per protocol eligibility criteria and was excluded from the efficacy analysis.
2 Response rate defined as ≥50% reduction in MADRS score.
3 Remission rate defined as MADRS score ≤10.
About Beckley Psytech and BPL-003
Beckley Psytech is a private clinical-stage biopharmaceutical company developing BPL-003, which is 5-MeO-DMT, a short-duration psychedelic tryptamine that binds to a variety of serotonergic receptors. Epidemiological surveys and observational studies have reported that 5-MeO-DMT is associated with improvements in mood, anxiety, reduced stress, increased life satisfaction and mindfulness. 5-MeO-DMT has been reported to produce mystical experiences with comparative intensity as seen with high doses of psilocybin but has a significantly shorter duration of effect. Phase 1 data showed BPL-003 to be well-tolerated with consistent dose delivery and a reproducible, dose-linear pharmacokinetic profile.
In January 2024, atai made a strategic investment in Beckley Psytech, resulting in a 35.5% ownership stake and 1:1 warrant coverage at a 30% premium on the primary issuances. atai holds a time-limited right of first refusal on a future sale of the company and an indefinite right of first negotiation for BPL-003 and ELE-101. atai and Beckley Psytech also agreed to collaborate on digital therapeutics, commercial and market access activities in preparation for future potential commercialization.
About atai Life Sciences
atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders and was founded as a response to the significant unmet need and lack of innovation in the mental health treatment landscape. atai is dedicated to efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines to achieve clinically meaningful and sustained behavioral change in mental health patients. atai's vision is to heal mental health disorders so that everyone, everywhere can live a more fulfilled life. For more information, please visit www.atai.life.
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