ATAI - Atai Life stock slumps 40% as depression drug fails mid-stage study

Atai Life Sciences ( NASDAQ: ATAI ) said its majority-owned unit Perception Neuroscience's therapy PCN-101 (R-ketamine)  did not meet the main goal of a phase 2a trial for treatment-resistant depression.

The study evaluated efficacy of a single IV administration of PCN-101 versus placebo. The trial enrolled 102 patients with TRD across three groups - 30mg, 60mg and placebo.

The company said the study did not meet its main goal of showing statistically significant change from baseline in participants' MADRS (Montgomery-A?sberg Depression Rating Scale) score at 24 hours compared to placebo.

On the main goal 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, according to the company.

The company added that key secondary goals 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.

Atai, however, noted that 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, the company added.

Atai added that it will further evaluate the PCN-101 data in more detail over the next weeks and will work with its subsidiary Perception to explore next steps, including but not limited to seeking strategic partnership options.

ATAI -42.59% premarket to $1.51

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