The article Atai Starts New Phase 1 Study of PCN-101 (R-Ketamine) was originally published on Microdose.

Back in January, atai Life Sciences released results for its most advanced program: PCN-101 (using R-Ketamine for Treatment-Resistant Depression) 

Unfortunately for patients and investors, results were somewhat disappointing and “did not meet its primary endpoint of a statistically significant change from baseline”. 

The stock price dropped considerably and you could feel some momentum dissipate from atai fans and the surrounding community.

The company did however say it would “continue to support Perception’s development of PCN-101 through an additional IV-to-subcutaneous bridging study, which is currently on-track to be completed in the middle of 2023. In parallel, atai continues to work with Perception Neuroscience to explore strategic partnership options.”

And yesterday we received news of atai making good on its promise, announcing the start of a Phase 1 trial to evaluate the additional potential of its ketamine product in different delivery modes. 

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.

See the full press release below.

atai Life Sciences Announces First Subject Dosed in the Phase 1 IV-to-Subcutaneous Bridging Study of PCN-101 (R-Ketamine)

NEW YORK and BERLIN, April 13, 2023 (GLOBE NEWSWIRE) — atai Life Sciences (NASDAQ: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, announced that the first subject has been dosed in Perception Neuroscience’s Phase 1 intravenous-to-subcutaneous bridging study of PCN-101 (R-ketamine).

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 January 2023, atai announced results from the Phase 2a proof-of-concept study evaluating a single IV administration of PCN-101 in patients with treatment-resistant depression across three arms – 30mg, 60mg and placebo. While the results did not reach statistical significance on the primary endpoint, PCN-101 demonstrated an encouraging safety profile and signals of efficacy across all timepoints out to two weeks, potentially indicating a sustained duration of effect.

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, 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 of atai Life Sciences AG.

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 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.

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