Compass Pathways Announces Publication of Results from COMP004 Study on COMP360 Psilocybin for Treatment-Resistant Depression
Compass Pathways (NASDAQ: CMPS) has published results from its COMP004 study, a 52-week observational follow-up of Phase 2 trials evaluating COMP360 psilocybin for treatment-resistant depression (TRD). The study demonstrated that a single 25mg dose of COMP360 maintained antidepressant effects longer compared to lower doses.
Key findings show the median time to depressive event was 92 days for the 25mg group, versus 83 days (10mg) and 62 days (1mg). A post-hoc analysis revealed even more substantial differences, with 189 days for the 25mg group compared to 43 days (10mg) and 21 days (1mg).
The treatment was generally well-tolerated, with three participants reporting treatment emergent serious adverse events deemed unrelated to the study drug. The company expects top-line data from its ongoing Phase 3 COMP005 trial in Q2 2025, with 26-week COMP006 data anticipated in H2 2026.
Compass Pathways (NASDAQ: CMPS) ha pubblicato i risultati del suo studio COMP004, un follow-up osservazionale di 52 settimane dei trial di Fase 2 che valutano il COMP360 psilocibina per la depressione resistente al trattamento (TRD). Lo studio ha dimostrato che una singola dose di 25 mg di COMP360 ha mantenuto gli effetti antidepressivi più a lungo rispetto a dosi inferiori.
I risultati chiave mostrano che il tempo mediano fino all'evento depressivo è stato di 92 giorni per il gruppo da 25 mg, rispetto a 83 giorni (10 mg) e 62 giorni (1 mg). Un'analisi post-hoc ha rivelato differenze ancora più significative, con 189 giorni per il gruppo da 25 mg rispetto a 43 giorni (10 mg) e 21 giorni (1 mg).
Il trattamento è stato generalmente ben tollerato, con tre partecipanti che hanno segnalato eventi avversi gravi emergenti dal trattamento ritenuti non correlati al farmaco dello studio. L'azienda prevede di presentare i dati preliminari del suo trial di Fase 3 COMP005 nel secondo trimestre del 2025, con i dati del COMP006 di 26 settimane attesi per il secondo semestre del 2026.
Compass Pathways (NASDAQ: CMPS) ha publicado los resultados de su estudio COMP004, un seguimiento observacional de 52 semanas de ensayos de Fase 2 que evalúan el COMP360 psilocibina para la depresión resistente al tratamiento (TRD). El estudio demostró que una sola dosis de 25 mg de COMP360 mantuvo los efectos antidepresivos durante más tiempo en comparación con dosis más bajas.
Los hallazgos clave muestran que el tiempo mediano hasta el evento depresivo fue de 92 días para el grupo de 25 mg, frente a 83 días (10 mg) y 62 días (1 mg). Un análisis post-hoc reveló diferencias aún más sustanciales, con 189 días para el grupo de 25 mg en comparación con 43 días (10 mg) y 21 días (1 mg).
El tratamiento fue generalmente bien tolerado, con tres participantes reportando eventos adversos graves emergentes del tratamiento considerados no relacionados con el fármaco del estudio. La empresa espera datos preliminares de su ensayo en Fase 3 COMP005 en el segundo trimestre de 2025, con los datos del COMP006 de 26 semanas anticipados para el segundo semestre de 2026.
Compass Pathways (NASDAQ: CMPS)는 치료 저항성 우울증(TRD)을 위한 COMP360 실로시빈의 2상 시험을 평가한 52주 관찰 후속 연구인 COMP004 연구 결과를 발표했습니다. 이 연구는 25mg의 단일 용량이 더 낮은 용량에 비해 항우울 효과를 더 오랫동안 유지했다는 것을 보여주었습니다.
주요 발견에 따르면 우울증 사건까지의 중앙 시간은 25mg 그룹에서 92일이었고, 10mg 그룹은 83일, 1mg 그룹은 62일이었습니다. 후속 분석에서 25mg 그룹은 189일로, 10mg 그룹은 43일, 1mg 그룹은 21일로 더 큰 차이를 보였습니다.
치료는 일반적으로 잘 견뎌졌으며, 세 명의 참가자가 연구 약물과 무관한 심각한 부작용을 보고했습니다. 회사는 2025년 2분기에 진행 중인 3상 COMP005 시험의 주요 데이터를 예상하고 있으며, 2026년 하반기에는 26주 COMP006 데이터가 예상됩니다.
Compass Pathways (NASDAQ: CMPS) a publié les résultats de son étude COMP004, un suivi observational de 52 semaines des essais de Phase 2 évaluant le COMP360 psilocybine pour la dépression résistante au traitement (TRD). L'étude a démontré qu'une seule dose de 25 mg de COMP360 maintenait les effets antidépresseurs plus longtemps par rapport à des doses inférieures.
Les résultats clés montrent que le temps médian jusqu'à l'événement dépressif était de 92 jours pour le groupe de 25 mg, contre 83 jours (10 mg) et 62 jours (1 mg). Une analyse post-hoc a révélé des différences encore plus significatives, avec 189 jours pour le groupe de 25 mg contre 43 jours (10 mg) et 21 jours (1 mg).
Le traitement a été généralement bien toléré, trois participants ayant signalé des événements indésirables graves émergents du traitement jugés non liés au médicament de l'étude. L'entreprise s'attend à des données préliminaires de son essai de Phase 3 COMP005 au deuxième trimestre de 2025, avec des données de COMP006 de 26 semaines anticipées pour le second semestre de 2026.
Compass Pathways (NASDAQ: CMPS) hat die Ergebnisse seiner COMP004-Studie veröffentlicht, einer 52-wöchigen Beobachtungsnachuntersuchung von Phase-2-Studien zur Bewertung von COMP360 Psilocybin bei behandlungsresistenter Depression (TRD). Die Studie zeigte, dass eine einzelne Dosis von 25 mg COMP360 die antidepressiven Effekte länger aufrechterhielt als niedrigere Dosen.
Wichtige Ergebnisse zeigen, dass die Medianzeit bis zum depressiven Ereignis 92 Tage für die 25-mg-Gruppe betrug, im Vergleich zu 83 Tagen (10 mg) und 62 Tagen (1 mg). Eine post-hoc-Analyse ergab noch erhebliche Unterschiede, mit 189 Tagen für die 25-mg-Gruppe im Vergleich zu 43 Tagen (10 mg) und 21 Tagen (1 mg).
Die Behandlung wurde im Allgemeinen gut vertragen, wobei drei Teilnehmer von schwerwiegenden behandlungsbedingten Nebenwirkungen berichteten, die als nicht mit dem Studienmedikament verbunden angesehen wurden. Das Unternehmen erwartet im 2. Quartal 2025 erste Daten aus seiner laufenden Phase-3-Studie COMP005, während die Daten der 26-wöchigen COMP006-Studie für das 2. Halbjahr 2026 erwartet werden.
- Single 25mg dose showed significant durability of antidepressant effects up to 189 days in a subgroup
- Strong safety profile with no treatment-related serious adverse events
- Phase 3 clinical program is the largest randomized controlled psilocybin treatment trial ever conducted
- Results show eventual relapse in all dosage groups, requiring repeated treatments
- Long wait for Phase 3 trial results (Q2 2025 for primary endpoint)
Insights
Compass Pathways' published 52-week follow-up results represent a significant clinical advancement for their lead candidate COMP360 in treatment-resistant depression. The data demonstrates compelling durability differences between dose groups, with the 25mg dose showing median response duration of 92 days versus 83 and 62 days for lower doses.
Most notably, a subgroup analysis revealed substantially longer benefit for the 25mg group with median response of 189 days compared to just 43 and 21 days for lower doses. This potential for 6+ months of symptom relief from a single administration represents a paradigm shift for TRD patients who typically require daily medication.
The favorable safety profile, with no treatment-related serious adverse events, further strengthens COMP360's clinical profile. Importantly, these results now published in the Journal of Clinical Psychiatry provide peer-reviewed validation as the company advances into Phase 3 trials.
The addressable market is substantial, with approximately 100 million people worldwide affected by TRD. The upcoming data readout from the pivotal COMP005 trial in Q2 2025 represents the next critical catalyst that could validate these promising durability signals in a larger population.
The COMP004 follow-up study provides compelling evidence for COMP360's differentiated clinical profile in treatment-resistant depression. What stands out is the dose-dependent durability - a critical factor in TRD where maintaining remission is as challenging as achieving initial response.
The median 92-day response duration for the 25mg dose represents approximately three months of symptom relief from a single administration - remarkably longer than conventional antidepressants that require daily dosing and often show diminishing effectiveness over time.
The subgroup showing 189-day (approximately 6-month) durability is particularly intriguing. If Compass can identify predictive characteristics of these high-responders, it could enable targeted patient selection for maximum benefit.
From a clinical perspective, COMP360's mechanism - a single psilocybin administration with psychological support - represents a fundamentally different treatment paradigm. Unlike daily medications that often cause side effects and adherence challenges, this approach could significantly improve quality of life for TRD patients who have failed multiple treatment attempts.
The advancement to Phase 3 trials with a clear efficacy signal establishes COMP360 as a leading candidate in psychedelic medicine's clinical development. The forthcoming pivotal trial data will be important in determining whether these promising durability signals translate to a larger population.
Highlights:
- 52-week observational follow-up study from Phase 2b reveals single 25 mg COMP360 psilocybin dose offers longer-term antidepressant effects compared to lower doses, with average efficacy for a single dose of 25mg lasting about 12 weeks and substantially longer in a subgroup
- Findings published in the March edition of the Journal of Clinical Psychiatry
The results of COMP004 build upon previous findings from the Phase 2b trial COMP001, which showed that a single 25mg dose of COMP360 psilocybin was associated with a rapid and highly statistically significant reduction in depressive symptoms compared to COMP360 1mg dose after three weeks (p<0.001), with durable response for up to 12 weeks.
Key COMP004 findings
- Durable improvement in symptoms observed. The analysis of all patients in COMP001 revealed a longer time to relapse for patients receiving 25 mg compared with 10mg and 1 mg, with the median time to a depressive event of 92 days for the 25 mg dose group, 83 days for the 10 mg and 62 days for the 1 mg group.
- Extended benefit for a subgroup. A post hoc analysis revealed a substantial difference in time to depressive event for those who enrolled in COMP004 from COMP001 in the 25 mg group compared to the 10mg and 1mg groups, with median times of 189 days for the 25 mg group, 43 days for the 10 mg group, and 21 days for the 1 mg group.
- Safety monitoring. COMP360 was generally well tolerated. Three participants reported experiencing a treatment emergent serious adverse event (TESAE) post-enrollment to COMP004, occurring more than 6 months after a single dose administration and all deemed unrelated to study drug.
These COMP004 study data were published in the March edition of the Journal of Clinical Psychiatry.
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.
“Treatment-resistant depression is a major public health challenge, affecting approximately 100 million people worldwide, and it is well understood that there is an urgent need for differentiated treatment options,” said Dr. Guy Goodwin, Chief Medical Officer. “This study together with the Phase 2b (COMP001) suggest the potential of COMP360 to provide rapid and durable clinical benefits from a single administration. We continue to explore the full profile of COMP360 in our ongoing Phase 3 clinical development program and we look forward to seeing the first phase 3 data from our COMP005 trial in the second quarter.”
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 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 the COMP004 Trial
The COMP004 trial is a 52-week observational follow-up study on sixty-six participants from COMP001 (n=58 of which 22 participants were in the 25 mg arm, 19 participants were in the 10 mg arm and 17 participants were in the 1 mg arm) and COMP003 (n=8) trials to explore the long-term efficacy and safety of the three different doses of psilocybin (1 mg, 10 mg, and 25 mg) administered to patients with TRD as a monotherapy in COMP001 and 25 mg psilocybin administered as an adjunct to an SSRI in COMP003. Following completion of COMP001 or COMP003, as applicable, study participants had the option to enroll in COMP004 and there was a low rate of enrollment into COMP004. The analyses based solely on participants who enrolled in COMP004 are limited by the resulting selection bias.
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 time periods during which 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; 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, including that the results from this long-term follow-up study may not be predictive of the results for our phase 3 program in TRD; 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
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