Compass Pathways

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…

Compass Pathways (Nasdaq:CMPS) announced positive data from two early studies focused on using psilocybin therapy for anorexia nervosa and severe treatment-resistant depression.

The London-based company presented the results at the Society of Biological Psychiatry Annual Meeting in New Orleans.

In the anorexia nervosa study, 10 patients received a single 25 mg of the company’s COMP360 synthetic formulation of psilocybin. Almost one-third (30%) of the patients had clinically significant reductions in eating disorder psychopathology after one month. That figure rose to 40% at three months.

A total of 90% of study volunteers reported that the clinical trial was meaningful and therapeutic.

Participants reported no serious adverse events.

Dr. Walter Kaye at the University of California San Diego School of Medicine oversaw the study.

The second treatment recruited 12 individuals with severe treatment-resistant depression who had not respon…