Clinical-stage psychedelics biotech atai Life Sciences ATAI shared the results of its NYC-based subsidiary NYC-based Perception Neuroscience’s Phase 2a study of proprietary R-ketamine PCN-101 on patients with Treatment-Resistant Depression (TRD.).

The company stated that while the compound demonstrated efficacy signals across all time points, the trial 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 clinician‐rated measure of depressive severity.

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

Other key endpoints included a proportion of patients defined as responders -that is, who experienced 50% improvement from baseline in MADRS,- and a proportion of patients in remission -giving a total MADRS score of less than 10. 

On these measures, the trial did not meet statistical significance at any timepoint -although greater response and remission rates in the 60mg arm was recorded.

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

In view of the shared results, atai expressed that it will further evaluate the study data in more detail and work together with Perception to explore next steps, “including but not limited to seeking strategic partnership options.”

The company’s stock plunged 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.