- Atai Life Sciences (NASDAQ:ATAI)-owned Perception Neuroscience announced that the Phase 2a trial of PCN-101 (R-ketamine) did not meet its primary endpoint of a statistically significant change from baseline in participants’ MADRS (Montgomery-Åsberg Depression Rating Scale) score at 24 hours compared to placebo.
- MADRS is a widely used clinicianâ€rated measure of depressive severity.
- 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 treatment-resistant depression (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 the placebo.
- However, the single 60mg dose of PCN-101 showed an efficacy signal at each time point over the 2-week timeframe of the study.
- Key secondary endpoints included a proportion of patients defined as responders. Despite the greater response and remission rates in the 60mg arm, the trial did not meet statistical significance on these secondary measures.
- PCN-101 was generally well-tolerated with rates of sedation and dissociation comparable to placebo.
- Atai will further evaluate the PCN-101 data in more detail over the next weeks and work to explore the next steps, including seeking strategic partnership options.
- Price Action: ATAI shares are down 40.3% at $1.56 on the last check Friday.
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