Compass Pathways (NASDAQ: CMPS) announced that it has achieved the primary endpoint in the first of two ongoing Phase 3 trials evaluating COMP005 psilocybin for treatment-resistant depression (TRD).
The ongoing Phase 3 COMP005 trial is the first study of an investigational synthetic psilocybin—and the first classic psychedelic—to report Phase 3 efficacy data. The primary endpoint is the difference in change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) scores between the active treatment group and the placebo group at week six.
In a statement, Kabir Nath, CEO of Compass Pathways, commented, “The positive top-line results at week six from the COMP005 trial underscore the innovative potential of psilocybin treatment in mental health care for which Compass Pathways continues to pave the way. We are proud of this significant progress, which reflects our scientific rigor, operational excellence and steadfast commitment to serving patients living with TRD. 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. We remain focused on our goal of transforming the landscape of mental health treatment.”
Guy Goodwin, MD, CMO of Compass Pathways, added, “As we continue our Phase 3 program, we are very encouraged by the initial positive results and the highly statistically significant and clinically meaningful change in the MADRS score between the arms of the study 6 weeks after a single administration of COMP360. 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. This achievement provides hope that they can finally receive appropriate care and live the life they deserve. We are incredibly grateful to the participants, investigators and clinical sites for their invaluable contributions to this study.”
