Clinical-stage biopharmaceutical company atai Life Sciences ATAI announced the dosing of the first subject in phase 1 of its intravenous to subcutaneous phase 1 subsidiary Perception Neuroscience bridge study from proprietary R-ketamine, PCN-101.
The open-label study is designed to evaluate the safety, tolerability and pharmacokinetic profile of 60 mg, 90 mg and 120 mg of PCN-101 administered subcutaneously versus 60 mg of the compound administered intravenously in 16 healthy volunteers in four cohorts.
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 has the potential for fast-acting antidepressant activity and antisuicidal effects.
Although atai’s Phase 2a study of a single IV administration of 30 mg and 60 mg of PCN-101 in patients with treatment-resistant depression failed to meet its primary endpoint, it “demonstrated an encouraging safety profile and efficacy signals across time periods of two weeks, possibly indicating a sustained duration of action,” the company said.
The present IV-to-subcutaneous bridging study, which is expected to be completed by mid-2023, will potentially provide information on dosing regimens of the new subcutaneous formulation of PCN-101 for future studies and further exploration of the potential of R-ketamine as a fast-acting antidepressant for the human home use.
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