atai Life Sciences and Beckley Psytech Announce Positive Topline Results from the Phase 2b Study of BPL-003 in Patients with Treatment-Resistant Depression
atai Life Sciences (NASDAQ: ATAI) and Beckley Psytech announced positive topline results from their Phase 2b study of BPL-003 (intranasal mebufotenin) in treatment-resistant depression (TRD). The study, involving 193 patients across 38 sites in six countries, met its primary and all key secondary endpoints.
Both 8mg and 12mg single doses showed statistically significant improvements in depression symptoms compared to the 0.3mg control group. At Day 29, the 12mg dose showed a mean MADRS score reduction of 11.1 points versus 5.8 points in the control group (p=0.0038), while the 8mg dose achieved a 12.1-point reduction (p=0.0025). Effects were observed as early as Day 2 and maintained through Week 8.
The treatment demonstrated favorable safety with 99% of adverse events being mild or moderate, no drug-related serious adverse events, and no suicide-related safety signals. Most patients were ready for discharge within 90 minutes post-dose, suggesting compatibility with existing clinical treatment paradigms. Based on the results, the 8mg dose has been selected for Phase 3 development, pending regulatory consultation.
atai Life Sciences (NASDAQ: ATAI) e Beckley Psytech hanno annunciato risultati positivi preliminari dal loro studio di Fase 2b su BPL-003 (mebufotenina intranasale) nella depressione resistente al trattamento (TRD). Lo studio, che ha coinvolto 193 pazienti in 38 centri distribuiti in sei paesi, ha raggiunto l'endpoint primario e tutti gli endpoint secondari chiave.
Sia le dosaggi singoli da 8 mg che da 12 mg hanno mostrato miglioramenti statisticamente significativi nei sintomi depressivi rispetto al gruppo di controllo da 0,3 mg. Al giorno 29, la dose da 12 mg ha evidenziato una riduzione media del punteggio MADRS di 11,1 punti contro 5,8 punti nel gruppo di controllo (p=0,0038), mentre la dose da 8 mg ha raggiunto una riduzione di 12,1 punti (p=0,0025). Gli effetti sono stati osservati gi脿 dal giorno 2 e mantenuti fino alla settimana 8.
Il trattamento ha mostrato un profilo di sicurezza favorevole con il 99% degli eventi avversi classificati come lievi o moderati, nessun evento avverso grave correlato al farmaco e nessun segnale di sicurezza legato al rischio suicidario. La maggior parte dei pazienti 猫 stata pronta per la dimissione entro 90 minuti dalla somministrazione, suggerendo compatibilit脿 con i paradigmi clinici esistenti. In base ai risultati, la dose da 8 mg 猫 stata selezionata per lo sviluppo di Fase 3, in attesa di consultazioni regolatorie.
atai Life Sciences (NASDAQ: ATAI) y Beckley Psytech anunciaron resultados positivos preliminares de su estudio de Fase 2b con BPL-003 (mebufotenina intranasal) en la depresi贸n resistente al tratamiento (TRD). El estudio, que incluy贸 a 193 pacientes en 38 sitios de seis pa铆ses, cumpli贸 con su objetivo primario y todos los objetivos secundarios clave.
Tanto las dosis 煤nicas de 8 mg como de 12 mg mostraron mejoras estad铆sticamente significativas en los s铆ntomas de depresi贸n en comparaci贸n con el grupo control de 0,3 mg. Al d铆a 29, la dosis de 12 mg mostr贸 una reducci贸n media en la puntuaci贸n MADRS de 11,1 puntos frente a 5,8 puntos en el grupo control (p=0,0038), mientras que la dosis de 8 mg logr贸 una reducci贸n de 12,1 puntos (p=0,0025). Los efectos se observaron desde el d铆a 2 y se mantuvieron hasta la semana 8.
El tratamiento demostr贸 un perfil de seguridad favorable con el 99% de los eventos adversos siendo leves o moderados, sin eventos adversos graves relacionados con el f谩rmaco ni se帽ales de seguridad relacionadas con el suicidio. La mayor铆a de los pacientes estuvieron listos para el alta dentro de los 90 minutos posteriores a la dosis, lo que sugiere compatibilidad con los paradigmas cl铆nicos existentes. Basado en los resultados, la dosis de 8 mg ha sido seleccionada para el desarrollo de Fase 3, pendiente de consulta regulatoria.
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旃橂电� 攵�鞛戩毄鞚� 99%臧� 瓴届 霕愲姅 欷戨摫霃�鞓�鞙茧┌ 鞎诫 甏�霠� 欷戨寑頃� 鞚挫儊氚橃潙鞚� 鞐嗢棃瓿� 鞛愳偞 甏�霠� 鞎堨爠靹� 鞁犿樃霃� 鞐嗢棃鞀惦媹雼�. 雽�攵�攵勳潣 頇橃瀽臧� 韴棳 頉� 90攵� 鞚措偞鞐� 韲挫洂鞚� 臧�電ロ暣 旮办〈 鞛勳儊 旃橂 韺煬雼れ瀯瓿检潣 鞝來暕靹膘潉 鞁滌偓頃╇媹雼�. 瓴瓣臣毳� 氚旐儠鞙茧 8mg 鞖╇焿鞚� 3靸� 臧滊皽鞚� 鞙勴暣 靹犾爼霅橃棃鞙茧┌, 攴滌牅 雼龟淡瓿检潣 順戩潣臧� 鞓堨爼霅橃柎 鞛堨姷雼堧嫟.
atai Life Sciences (NASDAQ : ATAI) et Beckley Psytech ont annonc茅 des r茅sultats positifs pr茅liminaires de leur 茅tude de phase 2b sur le BPL-003 (m茅bufot茅nine intranasale) dans la d茅pression r茅sistante au traitement (TRD). L'茅tude, impliquant 193 patients r茅partis sur 38 sites dans six pays, a atteint son crit猫re principal ainsi que tous les crit猫res secondaires cl茅s.
Les doses uniques de 8 mg et 12 mg ont toutes deux montr茅 des am茅liorations statistiquement significatives des sympt么mes d茅pressifs par rapport au groupe t茅moin 脿 0,3 mg. Au jour 29, la dose de 12 mg a entra卯n茅 une r茅duction moyenne du score MADRS de 11,1 points contre 5,8 points dans le groupe t茅moin (p=0,0038), tandis que la dose de 8 mg a obtenu une r茅duction de 12,1 points (p=0,0025). Les effets ont 茅t茅 observ茅s d猫s le jour 2 et maintenus jusqu'脿 la semaine 8.
Le traitement a d茅montr茅 un profil de s茅curit茅 favorable avec 99 % des 茅v茅nements ind茅sirables 茅tant l茅gers ou mod茅r茅s, aucun 茅v茅nement ind茅sirable grave li茅 au m茅dicament et aucun signal de s茅curit茅 li茅 au risque suicidaire. La plupart des patients 茅taient pr锚ts 脿 sortir dans les 90 minutes suivant la dose, sugg茅rant une compatibilit茅 avec les paradigmes cliniques existants. Sur la base des r茅sultats, la dose de 8 mg a 茅t茅 s茅lectionn茅e pour le d茅veloppement de phase 3, sous r茅serve de consultations r茅glementaires.
atai Life Sciences (NASDAQ: ATAI) und Beckley Psytech gaben positive Zwischenergebnisse ihrer Phase-2b-Studie mit BPL-003 (intranasales Mebufotenin) bei therapieresistenter Depression (TRD) bekannt. Die Studie mit 193 Patienten an 38 Standorten in sechs L盲ndern erreichte sowohl den prim盲ren als auch alle wichtigen sekund盲ren Endpunkte.
Sowohl die einmaligen Dosen von 8 mg als auch 12 mg zeigten im Vergleich zur 0,3 mg Kontrollgruppe eine statistisch signifikante Verbesserung der Depressionssymptome. Am Tag 29 zeigte die 12 mg-Dosis eine durchschnittliche MADRS-Punktreduktion von 11,1 Punkten gegen眉ber 5,8 Punkten in der Kontrollgruppe (p=0,0038), w盲hrend die 8 mg-Dosis eine Reduktion um 12,1 Punkte erreichte (p=0,0025). Die Wirkung trat bereits am Tag 2 auf und hielt bis zur Woche 8 an.
Die Behandlung zeigte ein g眉nstiges Sicherheitsprofil mit 99 % der Nebenwirkungen als mild oder moderat, keine medikamentenbedingten schwerwiegenden unerw眉nschten Ereignisse und keine sicherheitsrelevanten Signale im Zusammenhang mit Suizid. Die meisten Patienten waren innerhalb von 90 Minuten nach der Gabe entlassungsbereit, was auf eine Kompatibilit盲t mit bestehenden klinischen Behandlungskonzepten hinweist. Basierend auf den Ergebnissen wurde die 8 mg-Dosis f眉r die Phase-3-Entwicklung ausgew盲hlt, vorbehaltlich regulatorischer Beratung.
- Both 8mg and 12mg doses showed statistically significant efficacy versus control
- Rapid onset of action with effects visible from Day 2
- Durable antidepressant effects maintained through Week 8
- High study completion rate of 90%
- Short clinical monitoring time with majority of patients ready for discharge at 90 minutes
- 8mg dose showed equivalent efficacy to 12mg with better tolerability
- Study success enables strategic combination between atai and Beckley Psytech to proceed
- Dose-related increases in administration site discomfort, nausea, headache, blood pressure and anxiety at 12mg dose
- Phase 3 trials still required before potential regulatory approval
- Additional regulatory consultations needed before proceeding to Phase 3
Insights
BPL-003 shows significant, rapid, and durable antidepressant effects in TRD patients with favorable safety profile and potential for clinic integration.
This Phase 2b study represents a significant advancement in the treatment landscape for treatment-resistant depression (TRD). The trial demonstrated that single doses of BPL-003 (intranasal mebufotenin) produced statistically significant reductions in depressive symptoms compared to the low-dose active control, with effects appearing as early as Day 2 and persisting through the 8-week follow-up period.
The Montgomery-脜sberg Depression Rating Scale (MADRS) results are particularly compelling - both the 8mg and 12mg doses showed mean reductions of approximately 11-12 points from baseline at Day 29 versus approximately 6 points in the control group. This magnitude of effect is considered clinically meaningful in TRD populations, where patients have failed multiple prior treatments.
What's especially notable is the durability of response. Many current antidepressants require daily administration to maintain efficacy, while BPL-003 demonstrated sustained effects for at least 8 weeks after a single administration. This could significantly reduce treatment burden for patients with chronic depression.
The safety profile appears favorable, with
The short in-clinic time requirement (majority ready for discharge at 90 minutes post-dose) suggests BPL-003 could fit within existing treatment paradigms established by Spravato庐, potentially offering improved practicality compared to other psychedelic therapies that often require extended monitoring.
With the 8mg dose showing equivalent efficacy but better tolerability than 12mg, advancing this dose to Phase 3 represents a rational development strategy that balances efficacy and safety considerations.
- Study met its primary and all key secondary endpoints, and BPL-003 demonstrated rapid, robust and durable antidepressant effects with a single dose
- Both 8 mg and 12 mg single doses of BPL-003 showed statistically significant and clinically meaningful reductions in depressive symptoms at all time points of the study compared to a 0.3 mg low-dose active control out to Week 8
- BPL-003 was generally well-tolerated at all doses, with
99% of treatment-emergent adverse events being mild or moderate, and no drug-related serious adverse events or suicide-related safety signals - Majority of patients deemed ready for discharge at the 90 minutes post-dose assessment, which suggests BPL-003 could fit within the existing 2-hour in-clinic interventional psychiatry treatment paradigm established by Spravato庐
- The Phase 2b study is the largest ever controlled study of mebufotenin (n=193) and the only blinded Phase 2 study of mebufotenin to include the United States
- Safety and efficacy data support the selection of the 8 mg dose to advance into Phase 3 clinical development, pending consultation with regulatory authorities
- Strategic combination between atai Life Sciences and Beckley Psytech to create a global leader in short time in-clinic psychedelic-based mental health therapies is expected to progress to shareholder approval stage
- Conference call scheduled for 8:00am EDT today, July 1, 2025
NEW YORK, and AMSTERDAM and OXFORD, United Kingdom, July 01, 2025 (GLOBE NEWSWIRE) -- 聽听(狈础厂顿础蚕: ATAI) (鈥渁tai鈥�), a clinical-stage biopharmaceutical company on a mission to develop highly effective mental health treatments to transform patient outcomes, and 聽(鈥淏eckley Psytech鈥�), a private clinical-stage biopharmaceutical company pioneering the next generation of mental health treatments, today jointly announced positive topline results from the eight-week, quadruple-masked, dose-finding, core stage of the Phase 2b clinical trial evaluating the efficacy and safety of a single dose of BPL-003 (intranasal mebufotenin (5-MeO-DMT) benzoate) in patients with treatment-resistant depression (TRD). The study achieved its primary endpoint as well as all key secondary endpoints. At Day 29, a single 12 mg dose of BPL-003 demonstrated a statistically significant reduction in depressive symptoms, as measured by the Montgomery-脜sberg Depression Rating Scale (MADRS), with a mean decrease of 11.1 points from baseline compared to a 5.8 point reduction in the 0.3 mg comparator group (p = 0.0038). For the key secondary efficacy endpoints, a single 8 mg dose of BPL-003 also showed significant improvement at Day 29, with a mean MADRS score reduction of 12.1 points (p=0.0025 for change vs. 0.3 mg control). Notably, both the 8mg and 12mg doses of BPL-003 showed statistically significant improvements in MADRS scores as early as one day after dosing, with effects generally maintained out to Week 8.
Safety and efficacy results from this study support the selection of the 8 mg dose of BPL-003 for advancement into Phase 3 clinical studies. atai and Beckley Psytech plan to engage with the U.S. Food and Drug Administration (FDA) and other applicable agencies regarding the Phase 3 trial design for patients with treatment-resistant depression in the coming months.
With these positive Phase 2b results, the pre-agreed success criteria for the proposed strategic combination between atai and Beckley Psytech, which was has been achieved and the strategic combination is now expected to progress to atai shareholder approval stage. The atai Beckley combination is expected to create a global leader in short time in-clinic psychedelic-based mental health therapies.
Cosmo Feilding Mellen, Chief Executive Officer and Co-Founder of Beckley Psytech, said: 鈥淭he achievement of our primary and secondary endpoints in this study represents an important milestone in the development of BPL-003 and reinforces its potential to be a viable treatment option for patients and healthcare systems. We are particularly encouraged that a single 8 mg or 12 mg dose of BPL-003 showed rapid and durable efficacy results, favourable tolerability and a short time in-clinic, giving us important flexibility in optimising the design of future trials. Thank you to all of the patients and study partners who participated in this study - we now look forward to preparing for end-of-Phase 2 meetings with regulators and moving forward with our strategic combination with atai Life Sciences to form atai Beckley, a global leader in psychedelic-based mental health treatments.鈥�
The Phase 2b clinical study was conducted at 38 sites across six countries and enrolled a total of 193 patients with moderate-to-severe TRD (defined as non-response to two or more prior treatments in the current depressive episode) (). It is the largest controlled clinical study to investigate mebufotenin and the only blinded Phase 2b study of mebufotenin to include the United States. Patients were randomized to receive a single 12 mg (n=73), 8 mg (n=46), or 0.3 mg comparator (n=74) dose of BPL-003 and were followed for eight weeks with efficacy assessments conducted by centralised, blinded raters using the MADRS at Day 2, Day 8, Day 29 and Day 57.
Key efficacy findings:
- A single 12 mg dose of BPL-003 led to a mean reduction in MADRS score from baseline of 11.1 points compared with 5.8 points in the 0.3 mg comparator arm (p=0.0038) at Day 29, with the 8 mg dose arm showing a mean MADRS reduction from baseline of 12.1 points versus the 0.3mg comparator arm (p=0.0025) at that same timepoint.
- The 8 mg and 12 mg doses of BPL-003 demonstrated equivalent efficacy suggesting the 8 mg dose may be sufficient to achieve therapeutic benefit from a single dose.
- The difference in MADRS scores between the 8 mg and 12 mg doses versus the 0.3 mg dose were statistically significant in both active arms from as early as Day 2, with mean MADRS reductions from baseline of 8.8 points in the 8 mg group and 8.9 points in the 12 mg group observed at that timepoint, compared to a reduction from baseline of 3.9 points in the 0.3 mg group. These mean reductions from baseline increased to 11.1 points in the 8 mg group and 10.8 points in the 12 mg group at Day 8.
- A durable effect was also observed for both higher doses, with the 8 mg group showing a mean reduction of 10.8 points from baseline at Day 57 and the 12 mg group showing a mean reduction of 10.2 points from baseline compared with the 0.3 mg group (5.2 point reduction). These findings highlight the potential of BPL-003 to be a durable treatment for patients with TRD.
Key safety findings:
- BPL-003 was generally well-tolerated at all doses. More than
99% of treatment-emergent adverse events (TEAEs) were mild or moderate and there were no drug-related serious adverse events (SAEs). - Dose related increases in administration site discomfort, nausea, headache, blood pressure and anxiety suggest the 8mg dose was better tolerated than the 12mg dose.
- No participants in the 8 mg nor 12 mg arms had any instance of treatment-emergent suicidal intent or behaviour, indicating no suicide-related safety signal observed to date.
- The average time to meet readiness for discharge criteria across all arms was within two hours of dosing, with the majority of patients deemed ready for discharge at the 90 minutes post-dose assessment. This, alongside the administration of BPL-003 via a previously approved nasal spray device, supports the potential of BPL-003 to fit within the existing interventional psychiatry treatment paradigm that has been successfully established by Spravato庐.
- The study had a low drop-out rate with
90% of patients completing the core study. - These findings suggest a favourable tolerability profile which are consistent with earlier Phase 1 and Phase 2a studies of BPL-003, as well as other psychedelic studies within the class.
Additional data from the core study is expected to be shared through publications and medical meetings in the future.
Dr David Feifel, Professor Emeritus of Psychiatry at the University of California, San Diego and Director of the Kadima Neuropsychiatry Institute said: 鈥�What stands out in these results is that a single administration of BPL-003 in patients with treatment-resistant depression was generally well tolerated and produced a robust antidepressant effect that emerged rapidly and was solidly sustained for at least two months. Notably, the acute psychedelic effects were shorter than with most other psychedelics studied clinically, suggesting potential for a quicker functional recovery for patients and a reduced need for prolonged monitoring. If a treatment with this profile were available today, it would immediately become my treatment of choice for TRD.鈥�
Follow-up in the eight-week open-label extension (OLE) stage of the study is ongoing. The OLE study is designed to evaluate the safety and efficacy of a second 12 mg dose of BPL-003 administered to patients eight weeks after dosing in the core study.
Commenting on the news, Srinivas Rao, Chief Executive Officer and Co-Founder of atai, said: 鈥淭hese findings strengthen our confidence in the potential of BPL-003 to be a transformative psychedelic therapy, offering rapid and durable antidepressive effects with minimal in-clinic time for patients with treatment-resistant depression. We look forward to engaging with the regulators later this year to advance this innovative treatment into Phase 3 clinical development.鈥�
Conference Call
atai and Beckley Psytech will host a conference call and live webcast today Tuesday, July 1, 2025, 2025 at 8:00 a.m. EDT. The conference call can be accessed by dialling 1-800-715-9871 for participants in the U.S. and 1-646-307-1963 for international callers, with the Conference ID: 1459387. The webcast can be accessed on the Investors section of atai鈥檚 corporate website under . The presentation and an archived replay of the webcast will be available in the same section of the website for a minimum of 30 days following the event.
About BPL-003
BPL-003 is Beckley Psytech鈥檚 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 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 across the globe, with around 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 , meaning there is a significant unmet need for more effective treatments.
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. atai鈥檚 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. It is 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 atai鈥檚 mission, visit or follow the Company on and on .
About Beckley Psytech
Beckley Psytech Ltd is a private biopharmaceutical company dedicated to improving the lives of people living with neuropsychiatric disorders by developing rapid-acting psychedelic medicines. Founded in 2019, and underpinned by more than two decades of pioneering scientific research from the Beckley Foundation, Beckley Psytech combines world-leading psychedelic science with extensive drug development expertise in order to optimise patient outcomes, improve treatment opportunities and ease the burden neuropsychiatric conditions have on individuals, healthcare systems and society. For more information about Beckley Psytech, visit or follow the Company on .
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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, (i) the Proposed Transaction may not be completed in a timely manner or at all, including the risk that any required shareholder approvals are not obtained; (ii) the failure to realize the anticipated benefits of the Proposed Transaction; (iii) the possibility that any or all of the various conditions to the consummation of the Proposed Transaction may not be satisfied or waived; (iv) the occurrence of any event, change or other circumstance that could give rise to the termination of the share purchase agreement; and (v) the effect of the announcement or pendency of the Proposed Transaction on atai鈥檚 ability to retain and hire key personnel, or its operating results and business generally and other important factors described in the section titled 鈥淩isk Factors鈥� in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (the 鈥淪EC鈥�), as such factors may be updated from time to time in atai鈥檚 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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FAQ
What were the key results of atai's Phase 2b BPL-003 trial for depression?
How long did the antidepressant effects of BPL-003 last in the ATAI clinical trial?
What is the safety profile of BPL-003 in ATAI's Phase 2b study?
How does BPL-003's clinical administration time compare to other treatments?
What is the next step for ATAI's BPL-003 depression treatment?
How many patients participated in ATAI's Phase 2b BPL-003 trial?
