Compass Unveils Safety Data For Psilocybin Phase 2 PTSD Study

In less than a week following the submission of the historic first request for approval of an MDMA treatment to the FDA, Compass Pathways has disclosed safety data from the phase 2 clinical study of psilocybin in post-traumatic stress disorder (PTSD).

PTSD is a focal point for psychedelic research, evidenced by the Multidisciplinary Association for Psychedelic Studies (MAPS) submitting an application to the FDA for MDMA medicine aimed at treating it. This marked a historic moment, being the first new drug submission for psychedelic-assisted therapy.

Compass has been actively assessing the safety and efficacy of its candidate, COMP360, which incorporates psilocybin—the psychoactive element found in magic mushrooms. The recent post-market release on December 19 provided insights from the evaluation of 22 participants within the initial 24 hours after receiving a 25 mg dose of the medication.

The biotech stated, “The initial data readout … indicated that COMP360 was well-tolerated and the safety profile was as expected, with no treatment-emergent serious adverse events recorded.”

In a statement, Compass’ Chief Medical Officer, Guy Goodwin, expressed satisfaction regarding the positive safety signals, emphasizing the crucial importance of safety in the development of potential new therapies. Goodwin said that the results align with those of other studies and trials, adding to the burgeoning body of proof that shows how COMP360 is so effective, especially when it comes to treating challenging mental health disorders.

However, patients will need to wait for a quite a while longer to obtain efficacy data. Compass is extending its monitoring period to 12 weeks after dosing, aiming to gather additional safety data and assess whether the drug has positively influenced participants’ PTSD. This comprehensive analysis of the trial’s outcomes, including safety metrics and potential therapeutic impacts, is anticipated to be available in the spring.

The trial spans both sides of the Atlantic, conducted at prominent institutions such as the Icahn School of Medicine at Mount Sinai in New York City, The Institute of Psychiatry, Psychology & Neuroscience at King’s College London and Sunstone Therapies in Maryland.

James Rucker, a consultant psychiatrist heading the trial in London, expressed optimism regarding the initial safety results for COMP360 psilocybin treatment in patients with PTSD. He emphasized the distressing nature of PTSD and the limitations of current treatments. Rucker looks forward to a more comprehensive analysis of the study, anticipated next year, to gain deeper insights into the potential efficacy and safety of the drug in the patient population.

Looking at psilocybin’s potential applications, Compass extends its ambitions beyond PTSD. Currently conducting two phase 3 trials, one for single-dose and the other for repeat-dose regimens of the drug, the company’s focus is on treatment-resistant depression. Expected to yield results in summer 2024 and mid-2025, respectively, these trials build upon positive phase 2 outcomes from two years ago. 

Additionally, a phase 2 trial is underway exploring psilocybin’s impact on anorexia nervosa. The broad spectrum of these trials underscores Compass’ comprehensive approach to unlocking the therapeutic potential of psilocybin.

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