After the Readout: How the Field Is Interpreting Compass' Phase 3 Psilocybin Data

On Tuesday, psilocybin developer Compass Pathways shared topline data from its Phase 3 program in treatment-resistant depression. We covered that readout extensively:

• BREAKING: Second Positive Phase 3 for Compass’ Psilocybin, Though Modest Magnitude Raises Questions
• Compass Provides Fuller Phase 3 Picture, MADRS Curves, on Webcast

We also reached out to researchers, practitioners, and executives across the psychedelics field to get their perspectives on the data and its potential implications. Below, we summarise their views…

FDA Approval: “When, Not If”?

The efficacy outcomes were modest, but still the required hit to get Compass past the finishing post.

Robin Carhart-Harris

A common theme we heard from those we spoke to was the belief that FDA approval for Compass’ program is now a matter of ‘when, not if.’

“I anticipate this will get approved”, Sandeep Nayak, Medical Director of the Johns Hopkins Center for Psychedelic & Consciousness Research, told Psychedelic Alpha. He pointed to various trial design features of the Phase 3 program, including the small proportion of participants with prior psychedelic experience, the generation of durability data, and the collection of ‘adverse events’ related to subjective drug effects. All three of these design features were viewed by FDA as deficient in the ill-fated Lykos Therapeutics (now Resilient Pharmaceuticals) MDMA new drug application (NDA), according to FDA’s complete response letter (CRL). On the safety front, too, he noted that the profile is generally “reassuring”, with no instances of suicidal ideation in the 25 mg arm of COMP006.

Psychedelic researcher Robin Carhart-Harris also believes the results should be sufficient for approval. “The efficacy outcomes were modest”, he told us, “but still the required hit to get Compass past the finishing post.” All-in-all, he added, “these results are more or less as I expected.”

Even Balazs Szigeti, a clinical data scientist at UCSF who was otherwise somewhat pessimistic about the efficacy data, believes that the present Phase 3 program “should be enough for FDA approval.”

British neuropsychopharmacologist and psychedelics researcher David Nutt, meanwhile, is hoping the data might be parlayed into international approvals. “I trust now that any residual doubters will now be satisfied”, the well-known researcher told Psychedelic Alpha, “and this remarkable medicine will be approved by USA, European and UK regulators.” It’s unclear, however, what that timeline looks like, with Compass appearing squarely focused on FDA approval.

With the company reporting two positive Phase 3 readouts, durability data out to week 26, and no new safety signals, there does seem to be a prevailing view...