Two Trials, One Signal: Compass Pathways Delivered
Congratulations to Compass Pathways!
The company just announced that its psilocybin therapy, COMP360, achieved the primary endpoint in its second Phase 3 trial for treatment-resistant depression (TRD).
Translation: in one of the hardest populations in psychiatry – people who haven’t responded to conventional antidepressants – it worked. Again.
Two large Phase 3 trials. Two successful primary endpoints.
This is not trivial.
Here’s what CEO Kabir Nath had to say …
Across three robust, well-designed, and well-executed clinical trials involving more than 1,000 participants, we have now demonstrated consistent, highly statistically significant results at the primary endpoint and a clinically meaningful effect.
This is a remarkable achievement for the field of psychiatry - especially in the TRD population, where proving benefit has historically been extraordinarily challenging. These data strengthen our conviction in the highly differentiated profile for COMP360. Given the urgent need for new treatments in TRD, we are advancing our discussions with the FDA, with the goal of submitting an NDA in Q4 and securing approval.
You can review the key findings here.
Also worth reading …
A Pill-Free Approach to Depression Gets FDA Approval: https://substack.com/@jlsfund/p-182087110
Single-dose psilocybin for U.S. military Veterans with severe treatment-resistant depression: https://www.sciencedirect.com/science/article/abs/pii/S0165032724016227
Psilocybin Rewires the Brain for People with Depression: https://www.ucsf.edu/news/2022/04/422606/psilocybin-rewires-brain-people-depression