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Compass Pathways’ COMP360 Psilocybin Shows Benefit in Phase 3 TRD Trial
A single 25 mg dose of synthetic psilocybin led to a significant reduction in depression severity at 6 weeks in the pivotal COMP005 trial for TRD, meeting its primary endpoint.
Compass Pathways announced positive phase 3 data from its ongoing COMP005 trial, which evaluates its synthetic psilocybin formulation COMP360 for treatment-resistant depression (TRD). A single 25-dose dose significantly reduced symptom severity on the Montgomery-Åsberg Depression Rating Scale (MADRS).
COMP005, the first of the 2 phase 3 trials evaluating COMP360 for TRD, met its primary endpoint: change from baseline in the MADRS scores between the active vs placebo group at week 6.
“As we continue our Phase 3 program, we are very encouraged by the initial positive results…” said Guy Goodwin, MD, chief medical officer of Compass Pathways, in a statement. “This progress marks an important milestone for patients living with TRD and highlights the groundbreaking work Compass Pathways is doing to bring innovative treatments to those who have been failed by multiple currently approved available treatment options.”
Approximately 21 million adults in the US live with major depression, and 9 million are medicated. However, about one-third of patients with MDD do not respond to the available treatments and have TRD.
Compass Pathways studied COMP360, a synthetic, proprietary formulation of psilocybin, as an alternative treatment for TRD. The ongoing COMP005 trial is a randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of COMP360 25 mg vs placebo among 258 participants with TRD across 32 sites in the US. The trial has 3 parts: blinded through 6 weeks, blinded through week 26, and an open-label treatment from week 26 to 52.
COMP005 showed a single dose of COMP360 25 mg brought statistically significant reduction in symptom severity on the MADRS score with a clinically meaningful difference from baseline of -3.6 (95% confidence interval [CI], -5.7 to -1.5; P < .001). The trial showed a consistent safety profile compared to earlier trials on COMP360 with no new safety findings. The analysis showed no clinically meaningful evidence of an imbalance between treatment arms in suicidality.
Compass Pathways is also conducting a second randomized, double-blind phase 3 trial assessing COMP360 for TRD. The trial, called COMP006, has 568 planned participants from North America and Europe and intends to evaluate 2 fixed doses, taken 3 weeks apart, of 25 mg COMP360 to 10 mg COMP260 and 1 mg COMP360. Like COMP005, COMP006 also comprises 3 parts: blinded through 9 weeks, blinded through week 26, and open-label treatment from week 26 to 52.
Compass Pathways plans to share 26-week data for COMP005 once all participants in COMP006 have completed the first part. The company expects to announce 26-week data from COMP006 in the second half of 2026. Furthermore, they plan to soon discuss the preliminary COMP005 data with the US Food and Drug Administration (FDA).
“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,” said Kabir Nath, Chief Executive Officer of Compass Pathways, in the statement. “We eagerly anticipate further insights once we have the full dataset and also look forward to findings from COMP006, which will explore the efficacy of two fixed doses.”
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