Atai Life Sciences says Phase 2a trial of PCN-101 did not meet primary endpoint

atai Life Sciences announced that, while PCN-101 demonstrated signals of efficacy across all timepoints out to two weeks, Perception Neuroscience’s Phase 2a clinical trial did not meet its primary endpoint of a statistically significant change from baseline in participants’ MADRS score at 24 hours compared to placebo. The Phase 2a proof-of-concept trial was a two-week, randomized, double-blind, placebo-controlled multi-center study assessing the safety, tolerability and efficacy of a single IV administration of PCN-101. 102 TRD patients were enrolled across three arms – 30mg, 60mg and placebo. On the primary endpoint of MADRS at 24 hours, the mean change from baseline was -15.3 for PCN-101 60mg compared to -13.7 for placebo. However, the single 60mg dose of PCN-101 showed an efficacy signal at each timepoint over the 2-week timeframe of the study. Key secondary endpoints included a proportion of patients defined as responders, meaning patients who experienced 50% improvement from baseline in MADRS, and a proportion of patients in remission, defined as a total MADRS score of less than 10. Despite seeing greater response and remission rates in the 60mg arm, the trial did not meet statistical significance at any timepoint on these secondary measures. PCN-101 was generally well-tolerated with rates of sedation and dissociation comparable to placebo. PCN-101 demonstrated an encouraging safety profile and signals of efficacy across all timepoints despite not achieving statistical significance on the primary endpoint. atai will further evaluate the PCN-101 data in more detail over the next weeks and will work with its subsidiary Perception Neuroscience to explore next steps, including but not limited to seeking strategic partnership options.