Compass Pathways Reports Lasting 12-Week Symptom Improvement in Phase 2 COMP360 Psilocybin PTSD Study

Compass Pathways plc, a biotechnology company focused on enhancing mental health treatment, has revealed promising top-line results from an open-label phase 2 study of their investigational COMP360 psilocybin treatment for post-traumatic stress disorder (PTSD). The study assessed the safety and efficacy of the treatment in 22 patients.

Importantly, the study achieved its primary safety objective, demonstrating that the administration of COMP360 was well-tolerated. No serious adverse events were observed. Additionally, the study also met various secondary efficacy endpoints, indicating substantial and lasting symptom improvement from baseline measurements.

Dr. Guy Goodwin, Chief Medical Officer of Compass Pathways, expressed optimism about the results, highlighting that even though it was a small, open-label study, the findings suggest that COMP360 could offer substantial symptomatic relief and enhance patients' daily functioning and quality of life. He emphasized that the absence of serious adverse events underscores the safety profile of COMP360 for PTSD patients.

In terms of safety, the study reported that adverse events included headache (50%), nausea (36.4%), crying (27.3%), and fatigue (27.3%). Two instances of suicidal ideation were recorded but resolved during the study. Both events were linked to the study drug and involved participants with a history of suicidality.

Efficacy measurements showed considerable improvements in PTSD symptoms and functional impairment. The mean CAPS-5 total score, a measure of PTSD severity, decreased by 29.9 points at week 4 and 29.5 points at week 12 from a baseline score of 47.5. Similarly, the Sheehan Disability Scale (SDS) scores, which measure functional impairment, showed an 11.7-point reduction at week 4 and a 14.4-point reduction at week 12 from a baseline score of 22.7.

High response and remission rates were observed early in the treatment process. At week 4, 81.8% of participants showed a significant improvement of at least 15 points in their CAPS-5 score, and 63.6% achieved remission. By week 12, 77.3% of participants sustained their response, and 54.5% remained in remission. Throughout the trial, no participants withdrew, and none returned to antidepressant medications.

Dr. James Rucker, the principal investigator, noted that PTSD is often underdiagnosed and inadequately treated, with no new medications approved in over two decades. The positive signals from this study provide hope for better treatment options.

Kabir Nath, CEO of Compass Pathways, echoed these sentiments, expressing confidence in further research efforts. He emphasized the potential of COMP360 to become a crucial treatment for various mental health conditions, including PTSD and treatment-resistant depression.

The phase 2 open-label study involved adult patients with PTSD from trauma. Participants received a single 25mg dose of COMP360 with psychological support, which was administered to ensure patient safety throughout the treatment session. The primary endpoint was safety at week 12, with secondary endpoints focusing on changes in CAPS-5 and SDS scores from baseline.

The average baseline severity was high, with a mean CAPS-5 total score of 47.5. Participants’ average age was 39, and those with complex PTSD were excluded from the study. The study was conducted at multiple locations, including King's College London, Icahn School of Medicine at Mount Sinai in New York, and Sunstone Therapies in Maryland.

In conclusion, the initial safety data previously released showed that COMP360 was well-tolerated, reinforcing the current findings. This study marks a significant step forward in developing effective treatments for PTSD, offering hope for those who have long suffered from this debilitating condition.