atai Life Sciences (NASDAQ:ATAI) shares tumbled more than 40% in pre-market trading on Friday after the company reported disappointing results from its subsidiary Perception Neuroscience’s Phase 2a clinical trial of PCN-101 (R-ketamine), a stereoisomer of ketamine, for treatment-resistant depression.
The biopharmaceutical company said in a statement that while PCN-101 demonstrated signs of efficacy across all time points out to two weeks, the trial did not meet its primary endpoint of a statistically significant change from baseline in participants’ Montgomery-Åsberg Depression Rating Scale (MADRS) score at 24 hours compared to placebo.
The 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 intravenous administration of PCN-101, atai added.
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102 treatment-resistant depression patients were enrolled across three arms: 30mg, 60mg and placebo.
The company said that PCN-101 demonstrated an encouraging safety profile and signals of efficacy across all time points despite not achieving statistical significance on the primary endpoint.
atai added that it will further evaluate the PCN-101 data in more detail over the coming weeks and will work with its subsidiary Perception Neuroscience to explore the next steps, including but not limited to seeking strategic partnership options.
“We thank all the patients, families, caregivers, and investigators for their support and participation in the PCN-101 Phase 2a trial,” said atai CEO Florian Brand.
atai’s Nasdaq-listed shares were down 41.1% at US$1.55 shortly before the market opened on Friday.
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