Compass Pathways (NASDAQ:CMPS) said its Phase 3 trial of its synthetic formulation of psilocybin, COMP360, in patients with treatment-resistant depression (TRD) met its primary endpoint.
A single 25mg dose of COMP360 demonstrated a statistically significant and meaningful reduction in depression symptom severity compared to placebo, with a mean difference of 3.6 points on the Montgomery-Åsberg Depression Rating Scale (MADRS) at week 6.
Investors, however, had hoped for a larger 5 to 6 point MADRS reduction, with shares of COMPASS trading down almost 45% late morning on Monday at about $2.50.
Safety data reviewed by an independent Data Safety Monitoring Board showed no unexpected safety issues and no clinically meaningful difference in suicidal ideation between the treatment and placebo groups.
The company plans to discuss these preliminary results with the Food and Drug Administration and continue with a second Phase 3 trial (COMP006), with longer-term data expected in late 2026.
“The positive top-line results at week 6 from the COMP005 trial underscore the innovative potential of psilocybin treatment in mental health care for which Compass Pathways continues to pave the way,” CEO Kabir Nath said in a statement.
“We are proud of this significant progress, which reflects our scientific rigor, operational excellence and steadfast commitment to serving patients living with TRD.”