Perception Neuroscience announces first dosing of subjects in the PCN-101 IV-to-subcutaneous bridging study
New York, NY
April 13, 2023
Today, Perception Neuroscience (“Perception”), a biopharmaceutical company, majority owned by atai Life Sciences, focused on developing innovative therapies in neuropsychiatric diseases announced the first subject has been dosed in a Phase 1 clinical study comparing three different subcutaneous (SC) doses of PCN-101 (R-ketamine) to a single dose of PCN-101 administered intravenously (IV). The goals of the study are to assess the pharmacokinetics and tolerability of the subcutaneous formulation for potential clinical development. The study will compare doses of 60 mg PCN-101-IV versus 60, 90, and 120 mg PCN-101 SC through a cross-over design. Sixteen volunteers have been enrolled in the study in order to ensure an appropriately powered comparison.
Terence Kelly, PhD, Chief Executive Officer at Perception stated: “This bridging study should allow Perception to migrate to subcutaneous administration in our planned future studies, which will facilitate a much easier drug administration and is in line with our ultimate goal of enabling this treatment for at-home use”.
Topline results are expected in mid-2023.
About Perception Neuroscience, Inc
Perception Neuroscience is a New York City- based biopharmaceutical company committed to developing therapies for neuropsychiatric diseases. Perception’s mission is to provide substantially more effective treatment solutions to serious psychiatric disorders. The company is a majority-owned subsidiary atai Life Sciences, AG.
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
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. For statements pertaining to atai, 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”). All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including without limitation statements regarding the success, cost, and timing of development of PCN-101 (R-ketamine), including the progress of clinical studies and clinical trials and related milestones and our participation in upcoming events and conferences.
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Contact Information
Terence Kelly, PhD
terry@perceptionneuroscience.com