Atai Advances R-Ketamine Through Phase 1 Bridging Study, Update And Near-Term Expectations

Clinical-stage biopharma company atai Life Sciences ATAI announced the dosing of the first subject in majority-owned subsidiary Perception Neuroscience’s Phase 1 intravenous-to-subcutaneous bridging study of proprietary R-ketamine, PCN-101.

Open-label, the trial is set to assess safety, tolerability and pharmacokinetic profile of 60mg, 90mg and 120mg of PCN-101 delivered subcutaneously as compared to 60mg of the compound delivered intravenously in 16 healthy volunteers across four cohorts.

PCN-101 is a single isomer of ketamine and belongs to a new generation of glutamate receptor modulators -pharmacologically, it works as a non-competitive NMDA receptor antagonist- that holds the potential for rapid-acting antidepressant activity and anti-suicidal effects.

Although atai’s Phase 2a study on a single IV administration of 30mg and 60mg of PCN-101 in patients with Treatment-Resistant Depression didn’t reach the primary endpoint, it demonstrated “an encouraging safety profile and signals of efficacy across all time points out to two weeks, potentially indicating a sustained duration of effect,” says the company.

The present IV-to-subcutaneous bridging study, with expected completion in mid-2023, will potentially inform dosing regimens of the new subcutaneous formulation of PCN-101 for future studies, supporting further exploration of the potential of R-ketamine as a rapid-acting antidepressant for at-home use.