The biotech’s investigational COMP360 psilocybin treatment showed positive safety and tolerability with no serious adverse events in a mid-stage study of people with post-traumatic stress disorder.
Pictured: Psilocybin science and research/iStock, 24K-Production
Mental health biotech Compass Pathways announced Tuesday its investigational psilocybin treatment for post-traumatic stress disorder was well-tolerated in an early read out of Phase II trial data.
The investigational treatment is based on Compass’ proprietary formulation of synthetic psilocybin. The trial was an open-label study of the safety and tolerability of the company’s psilocybin formulation, dubbed COMP360, in 22 adult patients in the U.S. and U.K. with post-traumatic stress disorder (PTSD) due to trauma experienced in adulthood.
Patients in the trial were monitored 24 hours after the administration of a single 25mg dose of COMP360. The safety profile was as expected with no serious treatment-emergent adverse events, according to Compass. Participants will go on to be monitored for a 12-week period post dosing, with data announced in the spring of 2024.
Compass touted the trial as the “first study reporting on the feasibility of psilocybin as a potential treatment for PTSD” in Tuesday’s announcement. According to the company, only 20% to 30% of the 300 million people who experience PTSD in their lives will make a full recovery with currently approved interventions.
The U.K.-based biotech is also studying COMP360 in other serious mental health disorders including treatment-resistant depression and anorexia nervosa. The psilocybin drug is already in two Phase III trials of single dose and repeated dose regimens for treatment-resistant depression. Readouts are expected mid-2024 and 2025. The anorexia program is in Phase II testing.
COMP360 is combined with psychotherapy in the trials. After building a relationship with the therapist, the patient’s dosing session involves lying down, taking the drug capsule, listening to a specially designed music playlist while wearing an eye mask. The session lasts six to eight hours under the supervision of a therapist.
Two states have now legalized psilocybin for supervised use—Oregon and Colorado—and 10 other states are considering proposals to lower or eliminate legal barriers to growing and using psilocybin mushrooms, commonly known as magic mushrooms.
Last week, MAPS Public Benefit Corporation submitted a New Drug Application to the FDA for an investigational MDMA-assisted therapy for individuals with PTSD. If approved by the FDA, the treatment would be the first psychedelic-assisted therapy in the U.S. In July 2023, Australia became the first country to make MDMA a prescription medication.
COMP360 has been designated a Breakthrough Therapy by the FDA and has received an Innovative Licensing and Access Pathway designation in the U.K. for treatment-resistant depression.
Last week, biotech MindMed reported topline data from a mid-stage study of its LSD-based drug in patients with generalized anxiety disorder.
Kate Goodwin is a freelance life science writer based in Des Moines, Iowa. She can be reached at kate.goodwin@biospace.com and on LinkedIn.
