Atai Life Sciences’ Drug Trial for Depression Fails to Produce Expected Results, Stock Plunges – ATAI Life Sciences (NASDAQ:ATAI)

Clinical-Stage Psychedelics Biotech Atai Life Sciences ATAE Shared the results of a Phase 2a study of the proprietary R-ketamine PCN-101 with NYC-based Perception Neuroscience on patients with treatment-resistant depression (TRD.).

The company said that although the compound demonstrated signs of efficacy at all time points, the trial met its primary endpoint of a statistically significant change from baseline in participants’ MADRS (Montgomery-Esberg Depression Rating Scale) scores at 24 hours compared to placebo. Didn’t finish the point. The MADRS is a widely used clinician-rated measure of depressive severity.

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

Other key endpoints included the proportion of patients defined as responders — ie, those who experienced a 50% improvement from baseline in the MADRS — and the proportion of patients in remission — given a total MADRS score of less than 10.

On these measures, the trial did not meet statistical significance at any time point – although greater response and remission rates were recorded in the 60mg arm.

PCN-101 was generally well-tolerated with rates of sedation and dissociation higher than placebo.

With the shared results in mind, Atai expressed that it will evaluate the study data in more detail and work closely with Notion to explore next steps, which include “exploring strategic partnership options, but Not limited to this.”

The stock of the company fell due to this news. At the close, the stock was trading at $1.86 per share, down 30%.

Photo: Edit Benzinga with photos by RODNAE Productions on Pexels and Doc James on Wikimedia Commons.

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