Abstracts
3431343
(#26) Durability of efficacy and safety of COMP360 psilocybin for treatment-resistant depression (TRD) across 26 weeks in an ongoing double-blind, randomized, controlled phase 3 study
Abstract: Introduction: COMP360 is a proprietary synthetic psilocybin formulation under investigation for treatment-resistant depression (TRD). COMP 005 is an ongoing phase 3, randomized, double-blind, placebo-controlled study evaluating its efficacy, safety, and tolerability. This analysis examines outcomes following one or two 25 mg administrations over 26 weeks.
Methods: Adults with TRD (2-4 inadequate prior treatment responses) were randomized 2:1 to single administration of COMP360 25 mg or placebo in Part A (6 weeks). The primary endpoint was change from baseline in MADRS total score at Week 6. In Part B (20 weeks), participants could receive a second administration if they did not achieve remission at Week 6 or subsequently met criteria for relapse. Descriptive statistics for MADRS change were assessed through Week 26.
Results: A total of 258 participants received COMP360 (n=171) or placebo (n=87) in Part A. COMP360 produced significantly greater reductions in MADRS scores versus placebo at all Part A time points, beginning Day 2 (LSM difference: -4.7; 95% CI: -7.0, -2.3; p 0.001) and sustained through Week 6 (-3.6; -5.7, -1.5; p 0.001). During Part B, numerical separation from placebo was maintained through Week 26. Second dosing occurred in 70% (COMP360) and 53% (placebo). Common TEAEs included headache, nausea, and visual hallucination, primarily on dosing days and resolving within 24 hours. Eleven SAEs occurred in 8 participants (4.7%).
Conclusions: Reductions in MADRS total scores following one or two administrations of COMP360 25 mg were observed to be rapid and sustained for at least 26 weeks.
Short Description: This phase 3 analysis of COMP360 psilocybin in treatment-resistant depression evaluates the efficacy, safety, and durability of one or two 25 mg administrations over 26 weeks. Rapid and clinically meaningful reductions in depressive symptoms were observed versus placebo, with effects sustained through the double-blind period.
Name of Sponsoring Organization(s): Compass Pathways
Methods: Adults with TRD (2-4 inadequate prior treatment responses) were randomized 2:1 to single administration of COMP360 25 mg or placebo in Part A (6 weeks). The primary endpoint was change from baseline in MADRS total score at Week 6. In Part B (20 weeks), participants could receive a second administration if they did not achieve remission at Week 6 or subsequently met criteria for relapse. Descriptive statistics for MADRS change were assessed through Week 26.
Results: A total of 258 participants received COMP360 (n=171) or placebo (n=87) in Part A. COMP360 produced significantly greater reductions in MADRS scores versus placebo at all Part A time points, beginning Day 2 (LSM difference: -4.7; 95% CI: -7.0, -2.3; p 0.001) and sustained through Week 6 (-3.6; -5.7, -1.5; p 0.001). During Part B, numerical separation from placebo was maintained through Week 26. Second dosing occurred in 70% (COMP360) and 53% (placebo). Common TEAEs included headache, nausea, and visual hallucination, primarily on dosing days and resolving within 24 hours. Eleven SAEs occurred in 8 participants (4.7%).
Conclusions: Reductions in MADRS total scores following one or two administrations of COMP360 25 mg were observed to be rapid and sustained for at least 26 weeks.
Short Description: This phase 3 analysis of COMP360 psilocybin in treatment-resistant depression evaluates the efficacy, safety, and durability of one or two 25 mg administrations over 26 weeks. Rapid and clinically meaningful reductions in depressive symptoms were observed versus placebo, with effects sustained through the double-blind period.
Name of Sponsoring Organization(s): Compass Pathways
