Abstracts
3431344
(#27) Efficacy and safety of COMP360 psilocybin for treatment-resistant depression (TRD) at primary endpoint in two ongoing phase 3 double-blind randomized controlled studies
Abstract: Introduction: COMP360 is a proprietary synthetic psilocybin formulation under investigation for treatment-resistant depression (TRD). COMP005 and COMP006 are ongoing phase 3, randomized, double-blind, controlled studies evaluating efficacy, safety, and tolerability. We assessed outcomes through the 6-week primary endpoint following one or two administrations.
Methods: Adults with TRD (2-4 inadequate prior treatment responses) were enrolled. In COMP005 (n=258), participants were randomized 2:1 to single administration of COMP360 25 mg or placebo. In COMP006, participants were randomized 2:1:1 to two doses (3 weeks apart) of COMP360 25 mg, 10 mg, or 1 mg. The primary endpoint in both studies was Week 6 change from baseline MADRS total score.
Results: In COMP005, COMP360 25 mg significantly reduced MADRS scores versus placebo at Week 6 (LSMD: -3.6; 95% CI: -5.7, -1.5; p 0.001), with significance from Day 2 onward. In COMP006 (n=581), two doses of 25 mg significantly reduced MADRS scores at Week 6 versus 1 mg (LSMD: -3.8; 95% CI: -5.8, -1.8; p 0.001); the 10 mg dose showed a smaller effect (LSMD: -2.5; 95% CI: -4.9, -0.2; p=0.016). Most TEAEs occurred on dosing days (65.6%-68.3%) and resolved within 1 day (84.3%-88%). Common TEAEs included headache, nausea, visual hallucinations, and anxiety. SAEs were infrequent (≤2.3%), with no meaningful imbalance in suicidality.
Conclusions:COMP360 25 mg produced rapid, clinically meaningful reductions in depressive symptoms across single- and two-dose paradigms at primary endpoint. The safety profile was consistent with the study drug's known profile and no imbalance in suicidality has been observed to date.
Short Description: This poster presents phase 3 primary endpoint results from COMP 005 and COMP 006 evaluating COMP360 psilocybin in treatment-resistant depression. One or two administrations of 25 mg produced rapid, clinically meaningful reductions in depressive symptoms versus control at the Week 6 primary endpoint, with effects observed as early as Day 2. The safety profile was consistent across studies, with most adverse events occurring on dosing days and resolving quickly.
Name of Sponsoring Organization(s): Compass Pathways
Methods: Adults with TRD (2-4 inadequate prior treatment responses) were enrolled. In COMP005 (n=258), participants were randomized 2:1 to single administration of COMP360 25 mg or placebo. In COMP006, participants were randomized 2:1:1 to two doses (3 weeks apart) of COMP360 25 mg, 10 mg, or 1 mg. The primary endpoint in both studies was Week 6 change from baseline MADRS total score.
Results: In COMP005, COMP360 25 mg significantly reduced MADRS scores versus placebo at Week 6 (LSMD: -3.6; 95% CI: -5.7, -1.5; p 0.001), with significance from Day 2 onward. In COMP006 (n=581), two doses of 25 mg significantly reduced MADRS scores at Week 6 versus 1 mg (LSMD: -3.8; 95% CI: -5.8, -1.8; p 0.001); the 10 mg dose showed a smaller effect (LSMD: -2.5; 95% CI: -4.9, -0.2; p=0.016). Most TEAEs occurred on dosing days (65.6%-68.3%) and resolved within 1 day (84.3%-88%). Common TEAEs included headache, nausea, visual hallucinations, and anxiety. SAEs were infrequent (≤2.3%), with no meaningful imbalance in suicidality.
Conclusions:COMP360 25 mg produced rapid, clinically meaningful reductions in depressive symptoms across single- and two-dose paradigms at primary endpoint. The safety profile was consistent with the study drug's known profile and no imbalance in suicidality has been observed to date.
Short Description: This poster presents phase 3 primary endpoint results from COMP 005 and COMP 006 evaluating COMP360 psilocybin in treatment-resistant depression. One or two administrations of 25 mg produced rapid, clinically meaningful reductions in depressive symptoms versus control at the Week 6 primary endpoint, with effects observed as early as Day 2. The safety profile was consistent across studies, with most adverse events occurring on dosing days and resolving quickly.
Name of Sponsoring Organization(s): Compass Pathways
