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New York-based Perception Neuroscience, the clinical-stage psychedelic biotechnology company Atai Life Sciences (NASDAQ: ATAI ), announced the results of its PCN-101 study of a specific R-ketamine in patients with treatment-resistant depression (TRD).
Although the combination showed signs of efficacy at all time points, the study did not reach the primary endpoint of a statistically significant change from baseline in participants' MADRS (Montgomery-Asberg Depression Rating Scale) at 24 hours compared to placebo, the company said. The MRS is a widely used clinically assessed measure of depression severity.
A two-week trial study evaluated the safety, tolerability, and efficacy of a single intravenous injection of PCN-101 in 102 patients with TRD.
Other primary endpoints were the proportion of patients defined as responders, i.e. the proportion of patients with a 50% improvement from baseline on the MADRS and the proportion of patients with an overall MADRS score of less than 10.
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For these measures, the study did not reach statistical significance, although response and remission rates were higher in the 60 mg group.
PCN-101 was generally well tolerated, with remission and withdrawal rates comparable to placebo.
Based on the overall results, Atai said it will look closely at the study data and work with understanding on next steps, "not limited to exploring strategic partnership options."
After this news, the share price of the company fell. Shares fell 30% to close at $1.86 per share.
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© 2023 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
© 2023 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.