Compass Monitors PTSD Progress as Psilocybin Therapy Reaches Midphase Data

More than half of the participants in a study by Compass Pathways were found to be in remission by Week 12. Compass Pathways, based in London, has recently announced positive midphase results, connecting its psilocybin therapy combined with psychological support to significant improvements in post-traumatic stress disorder (PTSD) in a small-scale study.

Primarily concentrating on treatment-resistant depression, for which it anticipates phase 3 data this year, Compass Pathways is also investigating the potential of its psilocybin treatment, COMP360, in treating PTSD. Their literature review indicates that only about 20% to 30% of patients achieve full remission with current PTSD therapies.

To evaluate whether COMP360, a formulation of the active substance found in magic mushrooms, could yield better outcomes, Compass enrolled 22 PTSD patients in an open-label phase 2 trial. Each participant received one dose of COMP360 along with psychological support from a licensed professional.

At the beginning of the trial, participants had an average score of 47.5 on the CAPS-5 symptom scale, signifying severe PTSD. After four weeks, Compass observed an average reduction of 29.9 points in the CAPS-5 scores. This reduction remained consistent, with a 29.5-point decrease observed at the 12-week mark. By Week 12, over half of the participants had scores of 20 or less, indicating remission. The study also reported two adverse events related to suicidal ideation, both of which resolved during the trial.

The drugs sertraline and paroxetine, sold under the names Zoloft and Paxil respectively, were approved for PTSD treatment over 20 years ago. Earlier this year, Lykos Therapeutics, formerly known as MAPS Public Benefit Corporation, applied for approval of its MDMA-assisted therapy for PTSD. Lykos’ approval application is based on two phase 3 trials demonstrating CAPS-5 score reductions of 24.4 and 23.7 points from baseline after 18 weeks. These Lykos studies were much larger than the Compass trial and included placebo control groups, making direct comparisons challenging. Nevertheless, Compass’ data appear promising, and the company is investigating the best way to proceed.

Compass argues that its therapy has several advantages over MDMA, the active ingredient in the street drug ecstasy or molly. During a Needham investor event in April, Compass CEO Kabir Nath emphasized that MDMA therapy requires intensive therapy, whereas COMP360 requires only psychological support.

Teri Loxam, Compass’ chief financial officer, discussed the future steps for PTSD at the same event. She mentioned that the company is considering a larger, later-stage trial for PTSD but did not include the costs in its current financial projections. Compass, which had nearly $263 million at the end of March, will need to secure additional funds or adjust its plans to finance further PTSD research.