Clinical-stage psychedelics biotech at Life Sciences ATAI announced the results of its New York-based Perception Neuroscience subsidiary’s Phase 2a study of its proprietary R-ketamine PCN-101 in patients with treatment-resistant depression (TRD.).

The company stated that while the compound showed efficacy signals at all time points, the study failed to 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 reached. MADRS is a widely used measure of depression severity assessed by physicians.

The two-week proof-of-concept study evaluated the safety, tolerability, and efficacy of a single IV administration of PCN-101 in 102 TRD patients.

Other important endpoints included a proportion of patients defined as responders – ie patients with a 50% improvement from baseline in MADRS – and a proportion of patients in remission – resulting in a total MADRS score of less than 10.

The study did not meet statistical significance at any time point for these measurements—although greater response and remission rates were recorded in the 60 mg arm.

PCN-101 was generally well tolerated, with sedation and dissociation rates comparable to placebo.

In light of the joint findings, atai stated that it will evaluate the study data in more detail and will work with Perception to explore next steps, “including but not limited to exploring strategic partnership options.”

The company’s shares plummeted on the news. At the close, the stock was trading at $1.86 per share, down 30%.

Photo: Benzinga edit with photo by RODNAE Productions on Pexels and Doc James on Wikimedia Commons.