New data from two late-stage clinical trials indicate that Compass Pathways’ psilocybin-based therapy, COMP360, may be on track for approval by the U.S. Food and Drug Administration (FDA) for treatment-resistant depression (TRD). Both company executives and industry analysts highlighted the durability of the treatment’s effects and a consistent safety profile.
The Phase 3 COMP006 trial met its primary endpoint, with participants receiving two 25-mg doses of COMP360 three weeks apart showing a 3.8-point improvement on the Montgomery-Åsberg Depression Rating Scale (MADRS) compared to those who received a 1 mg dose after six weeks. According to Compass’ press release, this represented a “highly statistically significant reduction in symptom severity.”
Compass also shared results from the Phase 3 COMP005 trial, which followed patients for 26 weeks after a single administration of COMP360. The company reported that “COMP360 maintained durability of effect at least through week 26 after just one or two doses.”
Lori Englebert, chief commercial officer at Compass, described this as “perhaps the most impressive” finding from the trials during an investor call. She contrasted these results with Johnson & Johnson’s Spravato, another TRD treatment approved in 2019 that requires dosing every one to two weeks following an initial series of treatments. Englebert said: “This is highly differentiated versus Spravato,” noting that Spravato is considered Compass’ main competitor in this space.
Chief Medical Officer Guy Goodwin emphasized that evidence of long-term effectiveness is important for regulators: “We’re providing that in spades,” he said, pointing out that the FDA had only requested data covering 12 weeks.
Steve Levine, chief patient officer at Compass, noted during the call that after 26 weeks in the COMP005 trial, 40% of patients who had shown at least a 25% reduction on MADRS and received a second dose went into disease remission. Levine stated: “[This] tells us not only that this group had a very meaningful initial response, but a second dose might deepen that.”
Analysts from Stifel commented favorably on these findings as well: “Early insights into durability look favorable, suggesting that patients who benefit early tend to fare well over time.” They also noted positive implications for regulatory approval based on these outcomes.
Safety data remained consistent with previous studies according to an independent Data Safety Monitoring Board chair cited by Compass: findings were similar to earlier research and there were no new or unexpected safety concerns. However, Stifel did point out several cases involving suicidal ideation among participants receiving the higher dose; company management clarified most instances were brief or occurred among nonresponders.
Compass has asked for a meeting with the FDA regarding its planned rolling New Drug Application (NDA), aiming to complete submission by year-end.
If approved by regulators, Englebert said: “If approved, COMP360 will be the first to market in a highly anticipated new class.” Despite progress toward approval and potential market entry ahead of competitors like Definium—especially after Lykos’ recent regulatory setback—analysts note there could still be delays due to psilocybin’s classification as a Schedule I substance by the Drug Enforcement Administration. H.C. Wainwright analyst Patrick Trucchio told BioSpace earlier this month that even if NDA submission follows today’s data release, launch before late 2027 would be optimistic.
