ATAI LIFE SCIENCES N.V. This Phase 1 open-label study is designed to assess the safety, tolerability, and pharmacokinetic profile of 60mg, 90mg and 120mg of PCN-101 delivered subcutaneously as compared to 60mg of PCN-101 delivered intravenously (IV). The trial will enroll approximately 16 healthy volunteers across the four cohorts and is expected to be completed in the middle of 2023.
In
This IV-to-subcutaneous bridging study will potentially inform dosing regimens of the new subcutaneous formulation that may optimize the therapeutic index-the balance of safety, tolerability and efficacy-of PCN-101 in future studies, thereby supporting further exploration of the potential of R-ketamine as a rapid acting anti-depressant for at-home use.
atai continues to work with Perception Neuroscience to explore strategic partnership options.
About
Perception Neuroscience is a
PCN-101 is a single isomer of ketamine and belongs to a new generation of glutamate receptor modulators with the potential for rapid-acting antidepressant activity and anti-suicidal effects. Pharmacologically, PCN-101 is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist. Depression model studies in rodents suggest that R-ketamine could possess more durable effects than S-ketamine and a more favorable safety and tolerability profile.
About
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.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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) and related studies; our business strategy and plans, including potential partnerships and other strategic arrangements and the plans and objectives of management for future operations and capital expenditures.
Any forward-looking statements made herein speak only as of the date of this press release, and you should not rely on forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, performance, or achievements reflected in the forward-looking statements will be achieved or will occur. Except as required by applicable law, we undertake no obligation to update any of these forward-looking statements for any reason after the date of this press release or to conform these statements to actual results or revised expectations.
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Email: IR@atai.life
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