atai Life Sciences Announces Strategic Investment in Beckley Psytech to Accelerate the Clinical Development of Short-Duration Psychedelics
atai Life Sciences (NASDAQ: ATAI) announced a strategic investment in Beckley Psytech Limited to accelerate the development of two patent-protected, clinical-stage psychedelic candidates, BPL-003 and ELE-101. Multiple clinical readouts are anticipated within the next 12 months, including a Phase 2b readout of BPL-003 in Treatment Resistant Depression in 2H24. BPL-003 has the potential to become a first-in-class short-duration psychedelic treatment with rapid acting and durable antidepressant effects.
The strategic investment by atai Life Sciences in Beckley Psytech represents a significant move within the biopharmaceutical sector, particularly in the niche market of psychedelic medicine for mental health disorders. The investment diversifies atai's portfolio, potentially strengthening its market position and creating shareholder value. The anticipation of multiple clinical readouts, including a Phase 2b readout of BPL-003, is a critical event that could significantly impact the company's valuation. If the results are positive and show a competitive advantage over existing treatments, such as rapid action and durability, this could lead to a reassessment of atai's growth prospects and risk profile.
Furthermore, the potential synergies in digital therapeutics and market access activities could streamline the path to commercialization, thereby reducing go-to-market time and costs. However, investors should consider the inherent risks of clinical trials and the regulatory hurdles that psychedelic substances face. The success of these compounds is not guaranteed and setbacks could adversely affect the company's financials and stock price.
The clinical-stage programs BPL-003 and ELE-101 are noteworthy due to their patent protection and potential as short-duration psychedelic treatments. The focus on Treatment Resistant Depression (TRD) is particularly relevant, as current treatment options are limited and often ineffective for a significant subset of patients. The promise of rapid-acting and durable antidepressant effects could meet a substantial unmet need in mental health care.
It is important to monitor the progress of these clinical trials closely, as the results will have implications for the future of psychedelic research and its acceptance in mainstream medicine. The success of these trials could pave the way for new treatment protocols and potentially disrupt the current mental health pharmaceutical market. However, the long-term impact will depend on the safety profile, efficacy compared to standard treatments and acceptance by the medical community and regulators.
The strategic investment in Beckley Psytech by atai Life Sciences could signal a broader industry trend towards the development of psychedelic medicines. This area of research is gaining traction, with increasing interest from both the scientific community and investors. The market for mental health treatments is vast and growing, with a significant demand for innovative and effective therapies.
Analyzing the potential market size for BPL-003 and ELE-101, especially considering their short-duration and rapid-acting properties, suggests a competitive edge in the patient experience and treatment logistics. This could lead to a higher adoption rate among healthcare providers and patients. However, market penetration will depend on several factors, including regulatory approval, reimbursement policies and the ability to scale production. The collaboration's focus on digital therapeutics could also offer a strategic advantage in terms of patient monitoring and treatment personalization, which is increasingly valued in the healthcare market.
01/04/2024 - 07:00 AM
Strategic investment in Beckley Psytech reinforces atai’s position as the biopharmaceutical company with the largest and most diverse portfolio of clinical-stage psychedelic candidates Two patent-protected, clinical-stage programs BPL-003 (intranasal 5-MeO-DMT) and ELE-101 (intravenous psilocin) complement atai’s existing drug development programs Multiple clinical readouts anticipated from this investment in Beckley Psytech within next 12 months, including a Phase 2b readout of BPL-003 in Treatment Resistant Depression in 2H24 BPL-003 has the potential to become a first-in-class short-duration psychedelic treatment with rapid acting and durable antidepressant effects Anticipated synergies through collaborating on digital therapeutics, commercial and market access activities in preparation for potential future commercialization atai to hold conference call & webcast on Thursday, January 4, 2024 at 8:00 a.m. ET NEW YORK and BERLIN, Jan. 04, 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 a strategic investment in Beckley Psytech Limited (“Beckley Psytech”), a private clinical-stage biotechnology company dedicated to transforming short-duration psychedelics into effective and rapid-acting medicines for neuropsychiatric conditions.
This strategic investment and collaboration aims to accelerate the development of Beckley Psytech’s two clinical-stage, patent-protected, short-duration psychedelic candidates, BPL-003 and ELE-101, by adding them to atai’s mental health innovation platform. BPL-003 is a novel, short-duration, intranasal formulation of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT also known as Mebufotenin), and ELE-101 is a novel intravenous formulation of psilocin, the primary moiety of psilocybin.
“This transaction underscores our conviction in the potential of psychedelics as groundbreaking treatments for people living with mental health disorders. Short-duration psychedelics have the potential to offer similar clinical benefit to longer-acting psychedelics, in a more efficient and scalable way, which could lead to increased patient access. By including BPL-003 and ELE-101 in the atai platform, we are building the largest portfolio of psychedelic compounds with prior clinical evidence,” said atai Founder and Chairman, Christian Angermayer.
Beckley Psytech’s CEO, Cosmo Feilding Mellen said: “ Beckley Psytech and atai Life Sciences share a vision for the future of mental health treatment, and we are excited to join forces on the journey to develop effective, accessible, rapid-acting psychedelic medicines for people in need. Alongside the financial investment, we are optimistic about the numerous possible synergies of this collaboration, especially in developing digital tools to optimize patient support and planning for future commercialization. We look forward to exploring these in the coming months.”
BPL-003 is currently in development for two indications: Treatment Resistant Depression (TRD) and Alcohol Use Disorder (AUD), with three clinical trials underway. The first trial is a global, multi-site, double-blind, randomized Phase 2b study in people living with TRD, evaluating the effects of a medium and high dose of BPL-003 against an active placebo comparator in 225 patients with moderate-to-severe TRD. Medium and high dosages were found to reliably induce profound psychedelic experiences in a completed Phase 1 trial, with a rapid onset of psychedelic effects within minutes and the resolution of all perceptual effects within 60-90 minutes. In addition to the Phase 2b study in TRD that is anticipated to read out in the second half of 2024, BPL-003 is also being investigated in two small Phase 2a open-label studies in TRD and AUD, with data expected in the first half of 2024 and mid 2024 respectively.
Beckley Psytech’s second candidate ELE-101 is being developed for the treatment of Major Depressive Disorder (MDD). This compound has the potential to offer the therapeutic benefits of psilocybin, which has demonstrated significant antidepressant effects in multiple clinical studies, in a more consistent, controllable, and shorter treatment paradigm of less than 2 hours. Initial results from the current ELE-01 Phase 1/2a study are anticipated in the first half of 2024.
atai Co-founder and Chief Executive Officer, Florian Brand added: “When it comes to mental health, there is no one-size-fits-all solution, and the diverse pharmacology of our drug candidates acknowledges the heterogeneity of neuropsychiatric patient populations. Looking ahead to the next 12 months, adding to our already strong pipeline of potential catalysts, we anticipate this investment will lead to several additional meaningful clinical readouts, including topline results from the BPL-003 Phase 2b study, expected in the second half of 2024.”
Under the terms of the investment Beckley Psytech will remain an independent, privately-owned company and atai will own 35.5% of Beckley Psytech. This is based on a $50m total investment, with a $40m direct investment into the company to fund ongoing research programs, and an additional $10m in secondary share purchases from existing shareholders. Upon closing, atai will receive 1:1 warrant coverage at a 30% premium on the primary issuances. atai will also have the right to appoint and hold 3 of the 9 seats in Beckley Psytech’s Board of Directors, and will hold a time-limited right of first refusal on a future sale of the company, asset sales or other transfer of commercial rights, as well as an indefinite right of first negotiation for BPL-003 and ELE-101.
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atai Life Sciences announced a strategic investment in Beckley Psytech Limited to accelerate the development of two patent-protected, clinical-stage psychedelic candidates, BPL-003 and ELE-101.
Multiple clinical readouts are anticipated within the next 12 months, including a Phase 2b readout of BPL-003 in Treatment Resistant Depression in 2H24.
BPL-003 has the potential to become a first-in-class short-duration psychedelic treatment with rapid acting and durable antidepressant effects.
