atai Life Sciences Announces Completion of Enrollment in Phase 2b Clinical Trial Evaluating BPL-003 for Treatment-Resistant Depression
atai Life Sciences (NASDAQ: ATAI) has completed enrollment for the core stage of its Phase 2b clinical trial evaluating BPL-003 (mebufotenin benzoate) for treatment-resistant depression (TRD). The trial enrolled 196 patients across 38 sites in six countries, testing 8mg and 12mg doses against a sub-perceptual dose.
The eight-week, quadruple-masked study aims to assess efficacy and safety in patients with moderate-to-severe depression who failed at least two prior treatments. Previous Phase 2a results showed promising outcomes, with 55% of patients achieving remission at Day 29 and 45% at Day 85 after a single 10mg dose. Notably, patients were dischargeable within two hours post-dosing.
An open-label extension stage continues to evaluate a second high dose of BPL-003. Topline results from the core stage are expected in mid-2025, with Phase 3 planning scheduled for the second half of 2025.
atai Life Sciences (NASDAQ: ATAI) ha completato l'arruolamento per la fase centrale del suo studio clinico di Fase 2b che valuta BPL-003 (benzoato di mebufotenina) per la depressione resistente al trattamento (TRD). Lo studio ha arruolato 196 pazienti in 38 centri in sei paesi, testando dosi di 8 mg e 12 mg contro una dose sub-percettiva.
Lo studio, della durata di otto settimane e con un design quadruplo cieco, mira a valutare l'efficacia e la sicurezza in pazienti con depressione da moderata a grave che non hanno risposto ad almeno due trattamenti precedenti. I risultati precedenti della Fase 2a hanno mostrato esiti promettenti, con il 55% dei pazienti che ha raggiunto la remissione al Giorno 29 e il 45% al Giorno 85 dopo una singola dose di 10 mg. È importante notare che i pazienti sono stati dimessi entro due ore dalla somministrazione.
Una fase di estensione a etichetta aperta continua a valutare una seconda dose alta di BPL-003. I risultati preliminari della fase centrale sono attesi per metà del 2025, con la pianificazione della Fase 3 programmata per la seconda metà del 2025.
atai Life Sciences (NASDAQ: ATAI) ha completado la inscripción para la etapa central de su ensayo clínico de Fase 2b que evalúa BPL-003 (benzoato de mebufotenina) para la depresión resistente al tratamiento (TRD). El ensayo inscribió a 196 pacientes en 38 sitios en seis países, probando dosis de 8 mg y 12 mg contra una dosis sub-perceptual.
El estudio de ocho semanas, con enmascaramiento cuádruple, tiene como objetivo evaluar la eficacia y la seguridad en pacientes con depresión moderada a severa que no han respondido a al menos dos tratamientos previos. Los resultados anteriores de la Fase 2a mostraron resultados prometedores, con el 55% de los pacientes alcanzando la remisión en el Día 29 y el 45% en el Día 85 después de una sola dosis de 10 mg. Es notable que los pacientes fueron dados de alta dentro de las dos horas posteriores a la dosificación.
Una fase de extensión a etiqueta abierta continúa evaluando una segunda dosis alta de BPL-003. Se esperan los resultados preliminares de la etapa central a mediados de 2025, con la planificación de la Fase 3 programada para la segunda mitad de 2025.
atai Life Sciences (NASDAQ: ATAI)는 치료 저항성 우울증 (TRD)을 위한 BPL-003 (메부포테닌 벤조산염)의 평가를 위한 2b상 임상 시험의 핵심 단계에 대한 등록을 완료했습니다. 이 시험은 6개국의 38개 사이트에서 196명의 환자를 등록하였으며, 8mg 및 12mg 용량을 서브 인지 용량과 비교하고 있습니다.
8주간의 4중 맹검 연구는 최소 두 가지 이전 치료에 실패한 중등도에서 중증 우울증 환자의 효능과 안전성을 평가하는 것을 목표로 하고 있습니다. 이전 2a상 결과는 유망한 결과를 보여주었으며, 29일째에 55%의 환자가 완화 상태에 도달하고 85일째에 45%가 10mg 단일 용량 후에 완화되었습니다. 특히, 환자들은 투약 후 2시간 이내에 퇴원할 수 있었습니다.
개방형 연장 단계에서는 BPL-003의 두 번째 고용량을 계속 평가하고 있습니다. 핵심 단계의 주요 결과는 2025년 중반에 예상되며, 3상 계획은 2025년 하반기로 예정되어 있습니다.
atai Life Sciences (NASDAQ: ATAI) a terminé l'inscription pour la phase centrale de son essai clinique de Phase 2b évaluant BPL-003 (benzoate de mébufoténine) pour la dépression résistante au traitement (TRD). L'essai a recruté 196 patients dans 38 sites répartis dans six pays, testant des doses de 8 mg et 12 mg par rapport à une dose sub-perceptible.
Cette étude de huit semaines, à double insu, vise à évaluer l'efficacité et la sécurité chez des patients souffrant de dépression modérée à sévère ayant échoué à au moins deux traitements antérieurs. Les résultats précédents de la Phase 2a ont montré des résultats prometteurs, avec 55 % des patients atteignant la rémission au Jour 29 et 45 % au Jour 85 après une seule dose de 10 mg. Il est à noter que les patients ont pu être libérés dans les deux heures suivant l'administration.
Une phase d'extension ouverte continue d'évaluer une deuxième dose élevée de BPL-003. Les résultats préliminaires de la phase centrale sont attendus pour mi-2025, avec une planification de la Phase 3 prévue pour la seconde moitié de 2025.
atai Life Sciences (NASDAQ: ATAI) hat die Rekrutierung für die Kernphase seiner Phase 2b-Studie abgeschlossen, die BPL-003 (Mebufoteninbenzoat) zur Behandlung von behandlungsresistenter Depression (TRD) bewertet. Die Studie hat 196 Patienten an 38 Standorten in sechs Ländern rekrutiert und testet Dosen von 8 mg und 12 mg gegen eine sub-perzeptuelle Dosis.
Die achtwöchige, vierfach verblindete Studie zielt darauf ab, die Wirksamkeit und Sicherheit bei Patienten mit moderater bis schwerer Depression zu bewerten, die auf mindestens zwei vorherige Behandlungen nicht angesprochen haben. Frühere Ergebnisse der Phase 2a zeigten vielversprechende Ergebnisse, wobei 55 % der Patienten am Tag 29 und 45 % am Tag 85 nach einer einzelnen Dosis von 10 mg in Remission gingen. Bemerkenswert ist, dass die Patienten innerhalb von zwei Stunden nach der Dosis entlassen werden konnten.
Eine offene Verlängerungsphase bewertet weiterhin eine zweite hohe Dosis von BPL-003. Die vorläufigen Ergebnisse der Kernphase werden für Mitte 2025 erwartet, mit einer Planung für Phase 3, die für die zweite Hälfte von 2025 vorgesehen ist.
- Strong Phase 2a results: 55% patient remission at Day 29
- Rapid treatment effect: patients dischargeable within 2 hours
- Large-scale Phase 2b trial: 196 patients across 38 sites
- Patent-protected proprietary intranasal formulation
- Results not expected until mid-2025
- Phase 3 planning delayed to second half 2025
- Remission rate declined to 45% by Day 85
Insights
atai Life Sciences has reached a significant milestone in its clinical program with the completion of enrollment in the core stage of its Phase 2b trial for BPL-003 in treatment-resistant depression (TRD). The trial has successfully enrolled 196 patients across 38 sites in six countries, evaluating two dose levels (8mg and 12mg) against a sub-perceptual dose.
This achievement keeps atai on track for topline results in mid-2025, with an established pathway toward end-of-Phase 2 regulatory meetings and Phase 3 planning in the second half of 2025. The clinical progress is particularly noteworthy given the promising Phase 2a data, where a single 10mg dose of BPL-003 demonstrated impressive efficacy with
What differentiates BPL-003 from other psychedelic-based treatments is its practical clinical application - patients were dischargeable within an average of less than two hours after dosing. This quick administration and monitoring period could provide a substantial competitive advantage and facilitate broader clinical adoption if ultimately approved.
The treatment's potential to deliver durable antidepressant effects from a single dose represents a potentially transformative approach for TRD patients who have failed multiple conventional therapies. The rigorous quadruple-masked study design adds scientific credibility to the eventual results and strengthens the program's regulatory positioning.
The completion of enrollment in atai's Phase 2b trial for BPL-003 represents a critical de-risking event in the development timeline of what could become a disruptive therapy in the treatment-resistant depression market. This milestone suggests strong operational execution by the Beckley Psytech team that atai has partnered with.
From a market perspective, BPL-003 offers three potentially compelling advantages: single-dose administration, rapid onset of effect, and sustained durability of response. The Phase 2a data showing remission rates of
The minimal clinical monitoring time (less than two hours) addresses one of the primary commercial barriers to psychedelic medicine adoption - the resource-intensive nature of administration. This could significantly expand the potential treatment settings and provider types that could offer the therapy, enhancing market access.
While still in mid-stage development, BPL-003's profile as the "largest controlled trial of mebufotenin" and the "first and only Phase 2b trial to investigate mebufotenin in the U.S." positions atai with potential first-mover advantages in this specific mechanism. The trial design targeting moderate-to-severe depression patients who failed at least two prior treatments aligns perfectly with the substantial unmet need in the TRD population.
Should the Phase 2b results replicate the promising Phase 2a findings, BPL-003 could represent a transformative treatment approach in a significant market opportunity, with potential for strong reimbursement support given the economic burden of treatment-resistant depression.
- The eight-week, quadruple-masked, dose-finding, core stage of the Phase 2b clinical trial is evaluating the efficacy and safety of a single dose of BPL-003 (mebufotenin benzoate) in patients with treatment-resistant depression
- The open-label extension stage of the Phase 2b clinical trial continues to enroll patients to evaluate the safety and efficacy of a second dose of BPL-003
- As previously reported, the Phase 2a study of BPL-003 in patients with treatment-resistant depression showed rapid and lasting antidepressant effects from a single dose, and patients were deemed ready for discharge within an average time of less than two hours after dosing
- Topline results from the core stage of the Phase 2b clinical trial are expected in mid-2025
NEW YORK and BERLIN, March 05, 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 the completion of patient enrollment in the eight-week, double-blind, core stage of the global Phase 2b clinical trial evaluating BPL-003 (mebufotenin benzoate) in patients with treatment-resistant depression (TRD). 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 effects from a single dose, with a short time in clinic. Topline results from the core stage of the Phase 2b clinical trial are expected in mid-2025.
“We are impressed by the Beckley Psytech team’s execution of the Phase 2b clinical trial of BPL-003 in patients with treatment-resistant depression, which is the largest controlled trial of mebufotenin and the first and only Phase 2b clinical trial to investigate mebufotenin in the U.S.,” stated Srinivas Rao, M.D., Ph.D., Chief Executive Officer and Co-founder of atai. “The promising data from earlier clinical studies of BPL-003 have demonstrated that a single dose can induce rapid, significant, and lasting antidepressant effects, further reinforcing our confidence in its potential to revolutionize treatment for difficult-to-treat depression. We look forward to the topline results from the eight-week core stage of the Phase 2b clinical trial of BPL-003, which remains on track for mid-2025.”
The eight-week, quadruple-masked, dose-finding, core stage of the Phase 2b clinical trial (NCT05870540) is evaluating the efficacy and safety of a single medium (8mg) or high (12mg) dose of BPL-003 against a sub-perceptual dose. The trial enrolled 196 patients with moderate-to-severe depression that had failed to respond to at least two or more prior treatments in the current episode of depression across 38 sites in six countries. Patients are followed for eight weeks, and efficacy is assessed at various timepoints by centralized, blinded raters using the Montgomery-Asberg Depression Rating Scale (MADRS).
The eight-week, open-label, extension stage of the Phase 2b clinical trial continues to enroll patients to evaluate the safety and efficacy of a second high dose of BPL-003 administered after the completion of the core stage of the trial.
Data from the Phase 2b clinical trial will be used in conjunction with data from the Phase 2a study of BPL-003 in patients with TRD to support end-of-Phase 2 meetings with regulatory bodies and Phase 3 planning in the second half of 2025. Initial Phase 2a data showed that a single 10mg dose of BPL-003 can produce a rapid and lasting antidepressant effect, with
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 effects from a single dose, with a short time in clinic. BPL-003 is being investigated for treatment-resistant depression (TRD) and for alcohol use disorder (AUD). In a Phase 2a study in patients with TRD, a single 10mg dose of BPL-003 produced a rapid antidepressant response in
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 an approximate one third ownership stake and 1:1 warrant coverage at a
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.
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, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “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. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements relating to our business strategy and plans; and 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 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) on March 28, 2024, 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.
Contact Information
Investor Contact:
IR@atai.life
Media Contact:
PR@atai.life
FAQ
What are the key findings from ATAI's Phase 2a trial of BPL-003 for treatment-resistant depression?
How many patients and sites are involved in ATAI's Phase 2b trial of BPL-003?
What dosages of BPL-003 are being tested in ATAI's Phase 2b trial?
When will ATAI release the topline results for BPL-003's Phase 2b trial?
What makes ATAI's BPL-003 trial significant in the mebufotenin research field?
