Among psychedelic companies, Compass Pathways plc (Nasdaq: CMPS) is noteworthy for having received Breakthrough Therapy designation from FDA for psilocybin in treatment-resistant depression in 2018. Now, Compass has completed the design of a Phase 3 pivotal study to test its COMP360 psilocybin therapy in treatment-resistant depression (TRD).
The Phase 3 study will be the first Phase 3 trial to investigate psilocybin internationally.
London-based Compass Pathways will divide its Phase 3 program into three clinical trials, which it anticipates will begin by the end of the year.
The first pivotal trial will test a 25-mg dose of psilocybin monotherapy against a placebo in approximately 378 volunteers.
The second study will administer a fixed repeat dose (1, 10 and 25 mg) in three dose arms. The trial aims to determine whether a repeat dose can improve recipients’ response.
Both pivotal studies will use change in MADRS score as the primary…