Study Results Revealed: Compass Pathways' Phase 2 Trial of COMP360 Psilocybin for Post-Traumatic Stress Disorder Shows Positive Outcomes
COMPASS Pathways Announces Promising Results from PTSD Study
COMPASS Pathways, a biotechnology company focused on mental health innovation, has made a significant stride in the treatment of Post-Traumatic Stress Disorder (PTSD). The company recently announced the publication of results from an open-label Phase 2 study evaluating the safety and tolerability of a single-dose of 25 mg of its investigational COMP360 synthetic psilocybin treatment.
The study, which involved 22 patients with PTSD, was conducted across three sites in the U.K. and the U.S., and included institutions such as King’s College London (UK), Johns Hopkins University (USA), and the Vancouver Coastal Health Research Institute (Canada).
The findings, published in the Journal of Psychopharmacology, show that COMP360 was well tolerated with no serious adverse events observed. High and sustained rates of response and remission relative to baseline were observed, with early onset of symptom improvement. Durable improvement in symptoms from baseline was observed out to 12 weeks following a single administration.
From a mean SDS total score of 22.7 at baseline, there was a 11.7 point reduction at week 4 and a 14.4 point reduction at week 12. Similarly, improvement in mean CAPS-5 total score from a baseline of 47.5 was observed, with a 29.9 point reduction at week 4 and a 29.5 point reduction at week 12.
The most common treatment-emergent adverse events included headache, nausea, crying, fatigue, and visual hallucinations.
COMP360, the proprietary formulation of synthetic psilocybin, has Breakthrough Therapy designation from the US FDA and ILAP designation in the UK for treatment-resistant depression (TRD). COMPASS Pathways is developing a new model of psilocybin treatment in conjunction with psychological support.
However, it's important to note that COMPASS Pathways' forward-looking statements are subject to risks and uncertainties, including clinical development risks, funding needs, regulatory approval, and commercialization challenges. The company's most recent annual report on Form 10-K, quarterly report on Form 10-Q, and prospectus supplement are available on the SEC's website.
PTSD affects approximately 5% of adults in the U.S. annually, making it an underserved condition with only two FDA-approved medications. COMPASS Pathways' work in this area could potentially fill a significant gap in treatment options.
For media inquiries, please contact Dana Sultan-Rothman at [email protected] or +1 484 432 0041. For investor inquiries, please contact Stephen Schultz at [email protected] or +1 401 290 7324. The press release source is available on businesswire.com.
COMPASS Pathways is headquartered in London, UK, with offices in New York, U.S. The company envisions a world where mental health means not just the absence of illness but the ability to thrive.
