COMPASS Pathways

Compass Pathways, in collaboration with the U.S. Department of Veterans Affairs, is launching the multicenter, double-blind, randomized PIVOT study to evaluate COMP360 psilocybin in veterans with treatment-resistant depression, including those with comorbid PTSD. Two doses of COMP360 will be compared, with an option for a second unblinded dose after four weeks; the primary endpoint is depression severity measured by MADRS. Compass will supply the drug as well as training and counseling materials; the study will run at five VA sites under the lead of the Birmingham VA Health Care System. » More on de.investing.com

A post-hoc analysis of an open-label phase 2 study of COMP360 in PTSD found that 78% of treatment sessions took place in silence and verbal interactions between participants and therapists were minimal. Support was predominantly non-directive and focused on presence, soothing and affirmation to promote autonomy in the introspective state. Compass Pathways has established a training and mentoring program for therapists; COMP360 holds Breakthrough Therapy designation in the US and an innovative approval in the UK for treatment‑resistant depression. » More on de.investing.com

The phase‑3 COMP006 study of COMP360‑psilocybin showed a clinically meaningful reduction in symptoms in 581 patients with chronic, treatment‑resistant depression: 39% achieved a response by week 6 after two fixed 25‑mg doses, which was maintained through week 26. Nearly 30% of responders achieved remission after a retreatment; by comparison, in the earlier COMP005 study 25% achieved a response after a single dose. Common adverse events included nausea, headache, anxiety and visual hallucinations; serious adverse events occurred in 5.7–6.3%. The company is pursuing a rolling FDA submission and, if approved, targets a market launch in H1 2027. » More on de.investing.com