Atai Advances R-Ketamine Through Phase 1 Bridging Study, Updates and Near-Term Expectations – ATAI Life Sciences (NASDAQ:ATAI)

clinical-stage biopharma company Atai Life Sciences ATAE Announces the Dose of the First Subject in Phase 1 Intravenous-to-Subcutaneous of Perception Neuroscience, a Majority-Owned Subsidiary bridging study Proprietary R-ketamine, PCN-101’s.

Open-label, trial set out to assess the safety, tolerability and pharmacokinetic profile of PCN-101 at 60mg, 90mg and 120mg subcutaneously compared to 60mg compound given intravenously in 16 healthy volunteers in four groups Has been given.

PCN-101 is a single isomer of ketamine and belongs to a new generation of glutamate receptor modulators – pharmacologically, it acts as a non-competitive NMDA receptor antagonist – that exhibit fast-acting antidepressant activity and anti-suicidality effects. has the capability of

Although Atai’s Phase 2a study on a single IV administration of 30mg and 60mg PCN-101 in patients with treatment-resistant depression did not reach the primary endpoint, it “demonstrated an encouraging safety profile and signs of efficacy at all time points” of two weeks, potentially indicating a sustained duration of impact,” the company says.

The current IV-to-subcutaneous bridging study, expected to be completed in mid-2023, will potentially inform future studies on the dosage of the new subcutaneous formulation of PCN-101, which rapidly induces R-ketamine. Supports further exploration of the potential of Acting antidepressant for home use.

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Photo: Benzinga edit with photos by True Touch Lifestyle on Shutterstock and Wikimedia Commons.

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