Although the company withheld detailed findings from the study of treatment-resistant depression, analysts at Stifel called COMP360’s efficacy “more than good enough” for registrational purposes.
Compass Pathway’s investigational psilocybin therapy COMP360 significantly eases symptoms in patients with treatment-resistant depression, clearing the way for regulatory discussions.
A release from the company on Monday was light on specifics, without any data on how a placebo arm performed. The company simply revealed that patients treated with COMP360 saw a 3.6-point reduction over six weeks versus placebo in their scores on the Montgomery-Åsberg Depression Rating Scale (MADRS), a validated tool to assess the severity of depressive symptoms. Compass called this outcome as “clinically meaningful” and “highly statistically significant.”
Analysts at Stifel agreed. The study, they wrote in a note to investors Monday morning, “was able to demonstrate meaningful MADRS separation—providing further evidence of efficacy.” Stifel, however, stopped short of saying whether COMP360’s outcome was “impressive or good enough,” citing several factors, not least of which is the lack of information available.
“It’s simply impossible to compare” Compass’ results with that from other depression studies “without knowing how the placebo arm performed,” the analysts wrote.
“From a FDA/registrational perspective though, this study clearly meets/exceeds the bar as the effect size is more than good enough, with a low p-value,” Stifel continued.
Compass only provided sparse safety data but did include a statement from a data safety monitoring board, which found that there were “no new or unexpected findings” and that suicidality or suicidal ideation was not worse in patients who received COMP360. Stifel found the panel’s commentary “encouraging.”
Compass plans to bring these early COMP360 data to the FDA while the biotech awaits the completion of a second pivotal study. Data from this second trial are expected in the second half of 2026.
COMP360 is a synthetic formulation of the psychedelic drug psilocybin. Phase II data published in The New England Journal of Medicine in late 2022 showed that a 25-mg dose of the drug candidate cut MADRS scores by 12 points over three weeks. Side effects were common, occurring in nearly 80% of treated participants, and included toxicities such as headache, nausea and suicidal ideations and behaviors or self-injury.
Monday’s readout delivers a fresh dose of good news to the psychedelic space, which recently has seen some signals of support from the Trump administration’s health leaders.
Last month, for instance, FDA Commissioner Marty Makary said that he was open to considering psychedelics for the treatment of neuropsychiatric diseases.
Regarding the use of psychedelics, “I don’t think the medical establishment is listening to doctors,” Makary said. “What have we had to treat traumatic brain injury and PTSD [post-traumatic stress disorder] that has really had great results?”
HHS Secretary Robert F. Kennedy, Jr. has also previously voiced support for psychedelics, even going as far as accusing the FDA of “suppressing” these treatments.
