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
atai Life Sciences (ATAI) announces positive initial results from BPL-003 Phase 2a study in Treatment Resistant Depression (TRD). A single dose demonstrated rapid and durable antidepressant effects, with 45% of patients in remission at week 12. BPL-003 showed good safety profile and was well-tolerated. Phase 2b study in 225 TRD patients underway with top-line results expected in H2 2024.
Positive
Positive initial results from BPL-003 Phase 2a study in TRD patients
45% of patients achieved clinical remission at week 12
55% of patients responded clinically on the day after dosing
Good safety profile and well-tolerated with no serious adverse events reported
Acute effects resolved in less than two hours
Phase 2b study in 225 TRD patients ongoing with results expected in H2 2024
The announcement of positive initial results from Beckley Psytech's Phase 2a study of BPL-003 presents potential implications for the pharmaceutical industry, particularly within the mental health and antidepressant market segments. The data indicating a rapid and sustained antidepressant effect in Treatment Resistant Depression (TRD) patients may signal a significant advancement in addressing the unmet needs of this patient population. The fact that 45% of patients were in clinical remission at week 12 suggests a potentially higher efficacy compared to existing treatments. The safety profile, as reported, aligns with industry expectations for Phase 2a studies, which typically focus on assessing safety and tolerability.
From an investor's perspective, the progress of BPL-003 through clinical trials could influence atai Life Sciences' market valuation as the drug represents a novel therapeutic approach. However, it is essential to consider that these results are preliminary and the upcoming Phase 2b study will be critical in confirming efficacy and safety on a larger scale. Given the size of the TRD market, a successful outcome could lead to significant revenue streams for atai Life Sciences. The reference to a potential fit within the Spravato® two-hour in-clinic treatment paradigm suggests a competitive advantage in terms of patient convenience and could impact adoption rates post-commercialization.
The therapeutic potential of BPL-003, as indicated by the initial results, could represent a paradigm shift in the treatment of TRD, a condition notoriously difficult to manage with current antidepressants. The use of 5-MeO-DMT, a psychedelic compound, aligns with emerging research suggesting rapid-acting antidepressant properties of psychedelics. The psychological support provided alongside the medication in the study underscores the importance of a holistic treatment approach in mental health care.
For healthcare providers and patients, the possibility of achieving clinical remission with a single dose could greatly reduce the burden of ongoing medication management and improve quality of life. However, the open-label design of the Phase 2a study may introduce bias and the small sample size limits the generalizability of the findings. The long-term effects and potential for relapse beyond the 12-week follow-up period remain to be investigated. These factors are vital for clinicians considering future treatment protocols and for investors evaluating the drug's commercial viability.
Analyzing the market impact of BPL-003's development, the current antidepressant market is ripe for innovation, especially for treatments that can demonstrate rapid and durable effects in TRD. The patient population for TRD is substantial, with an estimated 100 million people affected globally, presenting a significant market opportunity for atai Life Sciences. If BPL-003 successfully progresses through Phase 2b and subsequent studies, it could capture a significant share of this market.
The reported good safety profile and rapid resolution of acute effects are particularly noteworthy for market adoption, as these factors are important in the patient and clinician decision-making process. Moreover, the ability to administer BPL-003 intranasally could offer convenience and increase patient compliance compared to more invasive administration routes. The anticipation of top-line results from the Phase 2b study in H2 2024 will be a key milestone for investors and could potentially catalyze movements in atai's stock price.
03/27/2024 - 07:00 AM
- 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
Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “could,” “would,” “project,” “plan,” “potentially,” “preliminary,” “likely,” and the negative of these terms and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including without limitation our expectations and projections regarding the success, potential uses and timing of development of BPL-003 and related trials and studies, and our business strategy and plans.
Because forward-looking statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: clinical and preclinical development is uncertain, and our programs may experience delays or may never advance to clinical trials; our reliance on third parties to assist in conducting our clinical trials including failure by third parties to meet trial or testing deadlines; our reliance on qualified therapists working at third-party clinical trial sites to administer certain of our product candidates; the timing and outcome of regulatory review and/or approvals; research and development of drugs targeting the central nervous system, or CNS, is particularly difficult, and it can be difficult to predict and understand why a drug has a positive effect on some patients but not others; significant competition; obtaining, maintaining and protecting our intellectual property; restricted operating activity as a result of covenants in any financing arrangements; and operational activity. These forward-looking statements are subject to a number of important factors that could cause actual results to differ materially from those in the forward-looking statements, including the risks, uncertainties, and assumptions described in our Form 10-K for the year ended December 31, 2022, filed with the Securities and Exchange Commission (“SEC”) and our quarterly reports on Form 10-Q, as may be updated by other filings we file with or furnish to the SEC.
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atai Life Sciences announced positive initial results from Beckley Psytech’s Phase 2a open label study of BPL-003 in Treatment Resistant Depression (TRD). A single dose of BPL-003 showed rapid and durable antidepressant effects, with 45% of patients in remission at week 12.
55% of patients responded clinically on the day after dosing with BPL-003 in atai Life Sciences' Phase 2a study.
BPL-003 showed a good safety profile and was well-tolerated with no serious adverse events reported in the Phase 2a study.
atai Life Sciences has a Phase 2b study of BPL-003 in 225 TRD patients underway, with top-line results expected in H2 2024.
