Compass Pathways (Nasdaq: CMPS) announced today that its phase IIb clinical trial of COMP360 psilocybin therapy has achieved its primary endpoint. The biotech firm saw results “demonstrating a highly statistically significant and clinically relevant reduction in depressive symptom severity after three weeks”.
COMP360 is the firm’s proprietary formulation of synthetic psilocybin currently being developed for treatment-resistant depression. The firm also recently started a phase II trial for the psilocybin formulation as a potential treatment for post-traumatic stress disorder.
The double-blind trial saw 233 patients administered with varying single doses of COMP360: 25mg, 10mg, and 1mg. The results showed that there is a statistical difference in the Montgomery-Åsberg depression rating scale between the 25mg group and the 1mg group, with the former scoring -6.6 points from the baseline. This could mean that the group treated with the higher dose rated lower on the depression scale.
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On the other hand, the 10mg group showed no statistical difference compared to the 1mg group.
Further, 36.7% of the patients in the 25mg group showed significant responses at week 3 of the trial compared to 17.7 % in the 1mg group. 29.1% of the higher dose patients were also in remission at week 3 compared to 7.6% in the 1mg group.
The patients were reported to have generally tolerated the COMP360, with “more than 90% of treatment-emergent adverse events being mild or moderate in severity”. At least 179 patients reported one adverse event, with the most common being headache, nausea, fatigue, and insomnia. Out of these, 66 patients were from the 25mg group, 56 patients from the 10mg group, and 57 patients from the 1mg group.
On the other hand, 12 patients reported treatment-emergent serious adverse events, which includes suicidal behaviour, intentional self-injury, and suicidal ideation. From this, 5 patients came from the 25mg group, 6 patients from the 10mg group, and 1 patient from the 1mg group.
The trial was designed to find the appropriate larger dose for the phase III trial of the psilocybin therapy, which is expected to begin in 2022.
Compass Pathways last traded at US$43.04 on the Nasdaq.
Information for this briefing was found via Edgar and Compass Pathways. The author has no securities or affiliations related to this organization. Not a recommendation to buy or sell. Always do additional research and consult a professional before purchasing a security. The author holds no licenses.
