Compass Pathways Announces Completion of Recruitment for the Phase 3 COMP005 Trial of COMP360 Psilocybin for Treatment-Resistant Depression
Compass Pathways (NASDAQ: CMPS) has completed recruitment for its COMP005 phase 3 trial evaluating COMP360, a synthetic psilocybin treatment for treatment-resistant depression (TRD). Final participants are completing pre-dosing activities, including antidepressant medication washout where necessary.
The trial is part of the largest randomized, controlled, double-blind psilocybin treatment clinical program ever conducted. Top-line results for the 6-week primary endpoint are expected in late Q2 2025, while 26-week data will be available after all participants complete part A of the COMP006 trial, expected in second half 2026.
COMP360 is being investigated as a potential first-in-class psilocybin treatment for mental health conditions, administered with psychological support. TRD affects patients who don't respond adequately to at least two different treatments, with up to one-third of depression patients failing multiple treatment attempts.
Compass Pathways (NASDAQ: CMPS) ha completato il reclutamento per il suo trial di fase 3 COMP005 che valuta COMP360, un trattamento a base di psilocibina sintetica per la depressione resistente al trattamento (TRD). Gli ultimi partecipanti stanno completando le attività pre-dosaggio, inclusa la sospensione dei farmaci antidepressivi quando necessario.
Il trial fa parte del più grande programma clinico randomizzato, controllato e in doppio cieco mai condotto per il trattamento con psilocibina. I risultati preliminari per il punto finale primario di 6 settimane sono attesi entro la fine del secondo trimestre del 2025, mentre i dati a 26 settimane saranno disponibili dopo che tutti i partecipanti avranno completato la parte A del trial COMP006, prevista per la seconda metà del 2026.
COMP360 è in fase di studio come potenziale trattamento innovativo a base di psilocibina per le condizioni di salute mentale, somministrato con supporto psicologico. La TRD colpisce i pazienti che non rispondono adeguatamente ad almeno due trattamenti diversi, con fino a un terzo dei pazienti affetti da depressione che non riescono a ottenere risultati dopo vari tentativi di trattamento.
Compass Pathways (NASDAQ: CMPS) ha completado el reclutamiento para su ensayo de fase 3 COMP005 que evalúa COMP360, un tratamiento de psilocibina sintética para la depresión resistente al tratamiento (TRD). Los últimos participantes están completando actividades previas a la dosificación, incluida la suspensión de medicamentos antidepresivos cuando sea necesario.
El ensayo es parte del programa clínico de tratamiento con psilocibina más grande jamás realizado, que es aleatorizado, controlado y doble ciego. Se esperan resultados preliminares para el punto final primario de 6 semanas a finales del segundo trimestre de 2025, mientras que los datos a 26 semanas estarán disponibles después de que todos los participantes completen la parte A del ensayo COMP006, previsto para la segunda mitad de 2026.
COMP360 se está investigando como un posible tratamiento innovador de psilocibina para condiciones de salud mental, administrado con apoyo psicológico. La TRD afecta a pacientes que no responden adecuadamente a al menos dos tratamientos diferentes, con hasta un tercio de los pacientes con depresión que no logran resultados tras múltiples intentos de tratamiento.
컴파스 패스웨이즈 (NASDAQ: CMPS)는 치료 저항성 우울증 (TRD)을 위한 합성 실로시빈 치료제 COMP360을 평가하는 COMP005 3상 시험의 모집을 완료했습니다. 마지막 참가자들은 필요한 경우 항우울제 약물 세척을 포함한 사전 투약 활동을 완료하고 있습니다.
이번 시험은 지금까지 실시된 가장 큰 무작위, 대조, 이중 맹검 실로시빈 치료 임상 프로그램의 일환입니다. 6주 주요 결과에 대한 최종 결과는 2025년 2분기 말에 예상되며, 26주 데이터는 모든 참가자가 COMP006 시험의 A부분을 완료한 후 제공될 예정이며, 이는 2026년 하반기에 예상됩니다.
COMP360은 심리적 지원과 함께 제공되는 정신 건강 상태에 대한 잠재적인 최초의 실로시빈 치료제로 연구되고 있습니다. TRD는 최소 두 가지 다른 치료에 충분히 반응하지 않는 환자에게 영향을 미치며, 우울증 환자의 최대 3분의 1이 여러 치료 시도에서 실패하고 있습니다.
Compass Pathways (NASDAQ: CMPS) a terminé le recrutement pour son essai de phase 3 COMP005 évaluant COMP360, un traitement à base de psilocybine synthétique pour la dépression résistante au traitement (TRD). Les derniers participants achèvent les activités préalables à la dose, y compris l'arrêt des médicaments antidépresseurs si nécessaire.
L'essai fait partie du plus grand programme clinique randomisé, contrôlé et en double aveugle jamais réalisé pour le traitement à base de psilocybine. Les résultats préliminaires pour le critère principal de 6 semaines sont attendus à la fin du deuxième trimestre 2025, tandis que les données à 26 semaines seront disponibles après que tous les participants auront terminé la partie A de l'essai COMP006, prévu pour la seconde moitié de 2026.
COMP360 est étudié comme un traitement potentiel de première classe à base de psilocybine pour les troubles de la santé mentale, administré avec un soutien psychologique. La TRD touche les patients qui ne répondent pas de manière adéquate à au moins deux traitements différents, jusqu'à un tiers des patients dépressifs échouant à plusieurs tentatives de traitement.
Compass Pathways (NASDAQ: CMPS) hat die Rekrutierung für seine COMP005 Phase-3-Studie abgeschlossen, die COMP360, eine synthetische Psilocybin-Behandlung für behandlungsresistente Depression (TRD), evaluiert. Die letzten Teilnehmer schließen derzeit die Aktivitäten vor der Dosierung ab, einschließlich der Absetzung von Antidepressiva, wo dies erforderlich ist.
Die Studie ist Teil des größten randomisierten, kontrollierten, doppelblinden klinischen Programms zur Psilocybin-Behandlung, das jemals durchgeführt wurde. Die vorläufigen Ergebnisse für den 6-wöchigen primären Endpunkt werden Ende des zweiten Quartals 2025 erwartet, während die 26-Wochen-Daten verfügbar sein werden, nachdem alle Teilnehmer Teil A der COMP006-Studie abgeschlossen haben, die für die zweite Hälfte 2026 geplant ist.
COMP360 wird als potenzielle neuartige Psilocybin-Behandlung für psychische Erkrankungen untersucht, die mit psychologischer Unterstützung verabreicht wird. TRD betrifft Patienten, die nicht ausreichend auf mindestens zwei verschiedene Behandlungen ansprechen, wobei bis zu ein Drittel der Depressionspatienten bei mehreren Behandlungsversuchen scheitern.
- Completed recruitment for Phase 3 COMP005 trial ahead of key results
- Positioned to be first-in-class psilocybin treatment for TRD
- Largest ever psilocybin clinical program, enhancing data credibility
- Results not expected until Q2 2025, indicating long wait for potential revenue
- Extended timeline for complete data (26-week) stretching to H2 2026
- Requires patients to discontinue current antidepressants before treatment
Insights
Compass Pathways has reached a significant clinical development milestone with the completion of recruitment for its Phase 3 COMP005 trial of COMP360 psilocybin therapy for treatment-resistant depression (TRD).
The completion of enrollment in a pivotal Phase 3 study is a critical de-risking event in drug development, particularly for novel therapeutic approaches like psychedelic medicine. With screening closed and final participants scheduled for dosing, the company remains on track for their late Q2 2025 primary endpoint data readout, maintaining their development timeline.
This trial is part of what Compass describes as the largest randomized, controlled, double-blind psilocybin treatment clinical program ever conducted - signaling the robust nature of their clinical approach, which will be important for regulatory considerations. The trial's design suggests Compass is positioning COMP360 not as an alternative therapy but as a potential standard option for the substantial TRD population that fails to respond to conventional treatments.
The sequential data readout strategy - with 6-week primary endpoint data coming in Q2 2025, followed by longer-term 26-week data - indicates a carefully structured approach to demonstrate both short and sustained efficacy, critical considerations for regulatory approval in psychiatric conditions. With up to one-third of depression patients failing multiple treatment attempts, a successful trial could address a significant unmet medical need representing millions of potential patients.
Compass's announcement of completed recruitment for their lead program's Phase 3 trial reflects positive operational execution at a critical juncture. This milestone reduces one significant execution risk for the company - patient enrollment, which is often a challenge for novel therapeutic trials.
For a clinical-stage biotech with a market cap of approximately
The company's focus on treatment-resistant depression represents a substantial commercial opportunity - depression affects millions globally, with a significant percentage failing to respond to available treatments. If successful, COMP360 could potentially address an underserved market segment within the multi-billion dollar depression treatment landscape.
While positive, this milestone should be viewed as expected progress rather than a transformative catalyst. The more significant value inflection point remains the data readout in late Q2 2025. That binary event will substantially impact Compass's valuation and strategic options. Investors should recognize that while recruitment completion reduces operational risk, it doesn't change the probability of success for the trial itself.
The extended timeline to full results, with the COMP006 26-week data expected in H2 2026, highlights the lengthy development pathway remaining before potential commercialization.
Highlights:
- Screening closed for all sites and final participants being scheduled for dosing
- On track for top-line 6-week primary endpoint results in late Q2
“We are pleased that recruitment is complete in the 005 trial, bringing us one-step closer to delivering COMP360 as a potential first-in-class psilocybin treatment for patients with treatment resistant depression,” said Kabir Nath, Chief Executive Officer of Compass Pathways. “We await completion of dosing of the last participant, a milestone that we will also announce in the coming weeks, and we look forward to sharing the results of the 6-week primary endpoint in late Q2.”
COMP360 is a synthetic form of psilocybin under investigation as a treatment for certain difficult-to-treat mental health conditions when administered with psychological support.
TRD is a condition in which individuals with major depressive disorder do not respond adequately to at least two different treatments. Depression is the leading cause of disability and ill health worldwide. Up to two-thirds of people with depression are not helped by the first antidepressant medication they try. Up to a third of people with depression are failed by multiple attempts at treatment.
The pivotal phase 3 clinical program of COMP360 psilocybin treatment in TRD is the largest randomized, controlled, double-blind psilocybin treatment clinical program ever conducted. Top-line 6-week (primary endpoint) COMP005 data is expected late in the second quarter 2025 and 26-week COMP005 data is expected once all participants in the COMP006 trial have completed part A of the COMP006 trial. The COMP006 26-week data is expected in the second half of 2026.
About Compass Pathways
Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the
Compass is headquartered in
Forward-looking statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as “may”, “might”, “will”, “could”, “would”, “should”, “expect”, “intend”, “plan”, “objective”, “anticipate”, “believe”, “contemplate”, “estimate”, “predict”, “potential”, “continue” and “ongoing,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, statements regarding our business strategy and goals; our plans and expectations regarding our phase 3 trials in TRD, including our expectations regarding the number of participants that will be dosed and the time periods during which the dosing of all participants will be completed and the results of the two Phase 3 trials will become available; the potential for the pivotal phase 3 program in TRD, any future trials in PTSD, or other trials to support regulatory filings and approvals; our expectations regarding the safety or efficacy of our investigational COMP360 psilocybin treatment, including as a treatment for treatment of TRD; our ability to obtain regulatory approval and adequate coverage and reimbursement; and our ability to transition from a clinical-stage to a commercial-stage organization and effectively launch a commercial product, if regulatory approval is obtained. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Compass’s control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.
These risks, uncertainties, and other factors include, among others: uncertainties associated with risks related to clinical development which is a lengthy and expensive process with uncertain outcomes, and therefore our clinical trials may be delayed or terminated and may be more costly than expected; participants who have completed screening may not complete pre-dosing activities and enroll in our COMP005 trial; the results of early-stage clinical trials of our investigational COMP360 psilocybin treatment may not be predictive of the results of later stage clinical trials; our need for substantial additional funding to achieve our business goals and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our clinical trials; our efforts to obtain marketing approval from the applicable regulatory authorities in any jurisdiction for our investigational COMP360 psilocybin treatment may be unsuccessful; our efforts to commercialize and obtain coverage and reimbursement for our investigational COMP360 psilocybin treatment, if approved, may be unsuccessful; and those risks and uncertainties described under the heading “Risk Factors” in Compass’s most recent annual report on Form 10-K or quarterly report on Form 10-Q, and in other reports we have filed with the
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Enquiries
Media: Media, media@compasspathways.com
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324
Source: Compass Pathways plc
FAQ
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