atai Life Sciences Announces Positive Topline Data from Part 2 of Beckley Psytech’s Phase 2a Study of BPL-003 in Combination with SSRIs for Treatment-Resistant Depression
- Mean MADRS reduction of 18 points from baseline one day after dosing - Sustained efficacy with 19-point reduction at one month and 18-point reduction at three months - Average discharge time of less than two hours post-dosing - Well-tolerated with only mild to moderate adverse events
The company is currently conducting a larger Phase 2b study with 196 patients, the largest controlled clinical study of mebufotenin in the US, with results expected in mid-2025. These findings will support end-of-Phase 2 regulatory meetings and Phase 3 planning.
- Riduzione media del punteggio MADRS di 18 punti rispetto al basale un giorno dopo la somministrazione
- Efficacia sostenuta con una riduzione di 19 punti dopo un mese e di 18 punti dopo tre mesi
- Tempo medio di dimissione inferiore a due ore dopo la somministrazione
- Buona tollerabilità con eventi avversi da lievi a moderati
L'azienda sta attualmente conducendo uno studio più ampio di Fase 2b con 196 pazienti, il più grande studio clinico controllato su mebufotenina negli Stati Uniti, con risultati attesi a metà 2025. Questi dati supporteranno gli incontri regolatori di fine Fase 2 e la pianificazione della Fase 3.
- Reducción media del MADRS de 18 puntos desde el inicio un día después de la dosis
- Eficacia sostenida con una reducción de 19 puntos a un mes y 18 puntos a los tres meses
- Tiempo promedio de alta inferior a dos horas tras la dosis
- Bien tolerado, solo con eventos adversos leves a moderados
Actualmente, la compañía está llevando a cabo un estudio más amplio de Fase 2b con 196 pacientes, el estudio clínico controlado más grande de mebufotenina en EE. UU., con resultados esperados a mediados de 2025. Estos hallazgos respaldarán las reuniones regulatorias de fin de Fase 2 y la planificación de la Fase 3.
- 투여 1일 후 기준선 대비 MADRS 평균 18점 감소
- 1개월 후 19점, 3개월 후 18점 감소로 지속된 효능
- 투여 후 평균 퇴원 시간 2시간 미만
- 경증에서 중등도의 부작용만 있는 양호한 내약성
현재 회사는 196명의 환자를 대상으로 미국에서 가장 큰 메부포테닌 임상 2b상 시험을 진행 중이며, 결과는 2025년 중반에 발표될 예정입니다. 이 결과는 2상 종료 규제 미팅과 3상 계획 수립에 도움을 줄 것입니다.
- Réduction moyenne de 18 points au score MADRS par rapport au départ, un jour après la dose
- Efficacité maintenue avec une réduction de 19 points à un mois et de 18 points à trois mois
- Temps moyen de sortie inférieur à deux heures après la dose
- Bien toléré avec seulement des effets indésirables légers à modérés
L'entreprise mène actuellement une étude plus large de Phase 2b avec 196 patients, la plus grande étude clinique contrôlée sur la mébufoténine aux États-Unis, avec des résultats attendus à la mi-2025. Ces données soutiendront les réunions réglementaires de fin de Phase 2 et la planification de la Phase 3.
- Durchschnittliche MADRS-Reduktion von 18 Punkten gegenüber dem Ausgangswert einen Tag nach der Dosierung
- Anhaltende Wirksamkeit mit 19-Punkte-Reduktion nach einem Monat und 18-Punkte-Reduktion nach drei Monaten
- Durchschnittliche Entlassungszeit von weniger als zwei Stunden nach der Dosierung
- Gut verträglich mit nur milden bis moderaten Nebenwirkungen
Das Unternehmen führt derzeit eine größere Phase-2b-Studie mit 196 Patienten durch, die größte kontrollierte klinische Studie mit Mebufotenin in den USA, deren Ergebnisse Mitte 2025 erwartet werden. Diese Erkenntnisse werden die regulatorischen Gespräche zum Ende der Phase 2 und die Planung der Phase 3 unterstützen.
- Single dose of BPL-003 showed rapid and durable antidepressant effects lasting up to 3 months
- Significant MADRS score reductions of 18-19 points from baseline across multiple timepoints
- Quick patient discharge time of less than 2 hours post-treatment, supporting commercial scalability
- Well-tolerated safety profile with no serious adverse events reported
- Successful validation of co-administration approach with SSRIs, potentially improving accessibility
- Small sample size of only 12 patients in Phase 2a study
- Open-label study design limits interpretation of results
- Phase 2b results still pending, creating uncertainty about larger-scale efficacy
Insights
atai's BPL-003 shows promising Phase 2a results for treatment-resistant depression as an adjunct to SSRIs, demonstrating fast-acting, durable effects.
The Phase 2a clinical data for atai's BPL-003 (mebufotenin benzoate) represents a potentially significant advancement in the treatment-resistant depression (TRD) landscape. The open-label study demonstrated that a single dose of BPL-003, when administered alongside standard SSRIs, produced substantial clinical improvements – with mean MADRS reductions of 18 points one day post-dosing that remained relatively stable at 19 points after one month and 18 points after three months.
These MADRS reductions are clinically meaningful. For context, a reduction of ≥10 points on this scale is typically considered a clinically relevant response, while a reduction of ≥50% from baseline often defines remission in depression trials. The durability of effect (up to three months) is particularly notable in TRD, where treatment effects often diminish rapidly.
Two critical commercial aspects stand out: First, the average in-clinic time of less than two hours post-dosing suggests a potentially feasible treatment model similar to Spravato® (esketamine). Second, co-administration with SSRIs could simplify regulatory and adoption pathways, as it builds upon rather than replaces standard care.
However, several limitations warrant caution: This was a small (n=12), open-label study without a control group, making it vulnerable to placebo effects and investigator bias. The statement that patients were "dischargeable within two hours" suggests a rapid resolution of acute psychoactive effects, which would be advantageous from both safety and practical implementation perspectives.
The company's advancement of a larger Phase 2b study (n=196) indicates confidence in these preliminary findings. This upcoming randomized, quadruple-masked study represents the largest controlled trial of mebufotenin to date and will provide more definitive evidence of efficacy, with results expected mid-2025.
- Positive results show that a single dose of BPL-003, administered adjunctively to SSRIs, produced a rapid and durable antidepressant effect for up to three months after dosing
- BPL-003 was well-tolerated and patients were able to be discharged within an average time of less than two hours after dosing
- Data from the eight-week core, randomized stage of Beckley Psytech’s Phase 2b study of BPL-003 for treatment-resistant depression is expected in mid-2025
NEW YORK and BERLIN, May 20, 2025 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai” or “Company”), a clinical-stage biopharmaceutical company on a mission to develop highly effective mental health treatments to transform patient outcomes, today announced positive topline data from Part 2 of Beckley Psytech’s Phase 2a study (NCT05660642) of BPL-003 (mebufotenin benzoate), for treatment-resistant depression (TRD). The findings show that a single dose of BPL-003, when given to patients who were also taking defined selective serotonin reuptake inhibitors (SSRIs), was well-tolerated, with rapid and durable antidepressive effects of up to three months with an average in-clinic treatment time of less than two hours following dosing.
“We’re very encouraged by the growing body of data supporting BPL-003 as a potentially differentiated and commercially scalable interventional psychiatric treatment for depression,” stated Srinivas Rao, M.D., Ph.D., Chief Executive Officer and Co-founder of atai. “Patients with treatment-resistant depression face limited options and these results show that a single dose of BPL-003 can deliver rapid and durable antidepressant effects when co-administered with an SSRI, extending the positive results observed in the Part 1 monotherapy study. Although a small, open-label study, the data validates the co-administration approach, which could improve accessibility in the real-world setting. Congratulations to Cosmo, Rob and the Beckley team for continued execution of the BPL-003 program, and we look forward to the Phase 2b readout mid-year.”
The open-label Phase 2a study investigated the safety, efficacy and pharmacokinetics of a single dose of BPL-003 in 12 patients with moderate-to-severe depression, who had failed to respond to at least two or more prior treatments and were taking defined SSRIs. Patients were followed for 12 weeks post-dosing with assessments conducted at multiple points throughout the study.
BPL-003 was also shown to be well-tolerated. All adverse events were mild or moderate in severity and there were no serious adverse events reported (SAEs). Furthermore, acute effects resolved on the day of dosing with patients deemed dischargeable within an average time of less than two hours after dosing.
A single dose of BPL-003 induced rapid and long-lasting antidepressant effects, with a mean MADRS (Montgomery-Asberg Depression Rating Scale) reduction of 18 points from baseline observed the day after dosing, a mean MADRS reduction of 19 points from baseline observed one month after dosing, and a mean MADRS reduction of 18 points from baseline observed three months after dosing.
These findings demonstrate the potential of BPL-003 to deliver a commercially scalable single dose treatment model, if approved, that fits within the current interventional psychiatric care model established by Spravato®.
The results are also consistent with initial results from Part 1 of the study, which investigated BPL-003 as a monotherapy. Data from that study showed that a single dose of BPL-003 was well-tolerated and produced a rapid and lasting antidepressant effect for up to three months after dosing.
Beckley Psytech is expecting results from the core, randomized, quadruple-masked stage of its Phase 2b study of BPL-003 for TRD in mid-2025. The study enrolled 196 patients, which is the largest ever controlled clinical study to investigate mebufotenin and the only blinded Phase 2b study of mebufotenin in the United States. Data from the study will be used to support end-of-Phase 2 meetings with regulatory bodies and Phase 3 planning.
About BPL-003
BPL-003 is Beckley Psytech’s patent-protected, proprietary intranasal formulation of mebufotenin benzoate, administered via a nasal spray device used in a previously approved drug product. BPL-003 is designed to deliver rapid and durable antidepressant effects from a single dose, with a short time in the clinic and is being investigated as a potential therapy for treatment resistant depression (TRD) and for alcohol use disorder (AUD). BPL-003 is covered by granted US, UK and European composition-of-matter patents, with multiple further claims pending in various jurisdictions.
About Treatment-Resistant Depression
Depression is a debilitating and life-changing condition affecting nearly 300 million people across the globe, with around 52 million people affected by the condition in Europe and the US combined. Treatment resistant depression occurs when an individual does not respond to two or more courses of antidepressants and some studies show that it may affect up to
About Beckley Psytech
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 an approximate one third ownership stake and 1:1 warrant coverage at a
About atai Life Sciences
atai is a clinical-stage biopharmaceutical company on a mission to develop highly effective mental health treatments to transform patient outcomes. Our pipeline of psychedelic-based therapies includes VLS-01 (buccal film DMT) for treatment-resistant depression (TRD) and EMP-01 (oral R-MDMA) for social anxiety disorder, which are in Phase 2 clinical development. We are also advancing a drug discovery program to identify novel, non-hallucinogenic 5-HT2AR agonists for TRD. These programs aim to address the complex nature of mental health providing commercially scalable interventional psychiatry therapies that can integrate seamlessly into healthcare systems. For the latest updates and to learn more about our mission, visit www.atai.com or follow us on LinkedIn.
Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “anticipate,” “initiate,” “could,” “would,” “project,” “plan,” “potentially,” “preliminary,” “likely,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things: our business strategy and plans; the potential, success, cost and timing of development of our product candidates, and the product candidates of those companies we invest in, including the progress of preclinical and clinical trials and related milestones such as BPL-003 and related data readouts.
Forward-looking statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties that could cause actual results to differ materially from those projected, including, without limitation, the important factors described in the section titled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”), as such factors may be updated from time to time in atai's other filings with the SEC. atai disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by applicable law.
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