NEW YORK and BERLIN, Jan. 06, 2023 (GLOBE NEWSWIRE) — atai Life Sciences (NASDAQ: ATAI) (“atai” or “the Company”), a clinical-stage biopharmaceutical company focused on mental health, announced that, while PCN-101 (R-ketamine) demonstrated signals of efficacy across all timepoints out to two weeks, Perception Neuroscience’s Phase 2a clinical 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.
The Phase 2a 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 IV administration of PCN-101. 102 TRD patients were enrolled across three arms – 30mg, 60mg and placebo.
On the primary endpoint of MADRS at 24 hours, the mean change from baseline was -15.3 for PCN-101 60mg compared to -13.7 for placebo (-1.6 pbo-adj; p-value 0.5). However, the single 60mg dose of PCN-101 showed an efficacy signal at each timepoint over the 2-week timeframe of the study.
Key secondary endpoints 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. 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.
“We thank all the patients, families, caregivers, and investigators for their support and participation in the PCN-101 Phase 2a trial,” said Florian Brand, CEO and Co-Founder of atai.
PCN-101 demonstrated an encouraging safety profile and signals of efficacy across all timepoints despite not achieving statistical significance on the primary endpoint. atai will further evaluate the PCN-101 data in more detail over the next weeks and will work with its subsidiary Perception Neuroscience to explore next steps, including but not limited to seeking strategic partnership options.
PCN-101 Phase 2a Study Design
The Phase 2a proof-of-concept trial was a randomized, double-blind, placebo-controlled multi-center study assessing the safety, tolerability and efficacy of IV PCN-101 (R-ketamine) in 102 patients with TRD across three arms. These patients – all of whom had previously failed at least two rounds of antidepressants – received a single IV dose of either placebo, 30 mg, or 60 mg of PCN-101 adjunctively to their existing treatment regimen.
Patients were assessed for a change in depressive symptomatology using the Montgomery-Åsberg Depression Rating Scale (MADRS) at intervals over 14 days, with the primary endpoint at 24 hours post-dose. Dissociation and sedation were measured using the Clinician-Administered Dissociative States Scale (CADSS) and the Modified Observer’s Alertness/Sedation Scale (MOAA/S), respectively.
About Perception Neuroscience, Inc
Perception Neuroscience is a New York City-based clinical-stage biopharmaceutical company committed to the mission of providing more effective treatment solutions for serious psychiatric disorders. It is developing PCN-101 (R-ketamine) for the treatment of TRD. In March 2021, the company announced a collaboration and licensing agreement with Otsuka Pharmaceutical Co., Ltd. for rights in Japan to PCN-101. Perception Neuroscience is a majority-owned subsidiary of atai Life Sciences.
About atai Life Sciences
atai Life Sciences is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. Founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape, atai is dedicated to acquiring, incubating, and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders.
By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies to achieve clinically meaningful and sustained behavioral change in mental health patients.
atai’s vision is to heal mental health disorders so that everyone, everywhere can live a more fulfilled life. For more information, please visit www.atai.life.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “initiate,” “could,” “would,” “project,” “plan,” “potentially,” “preliminary,” “likely,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. All statements in this press release other than statements of historical fact are forward-looking statements, including, express or implied statements relating to, among other things: statements regarding the trials, results and our expectations related to any subsequent steps concerning the PCN-101 (R-ketamine) studies, data, or related plans and objectives of management for future operations, capital expenditures and capital allocation. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond our control and which could cause actual results, levels of activity, performance, or achievements to differ materially from those expressed or implied by these forward-looking statements.
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