FDA Approves atai Life Sciences IND for PCN-101 R-ketamine Program for Treatment-Resistant Depression

FDA Approves atai Life Sciences IND for PCN-101 R-ketamine Program for Treatment-Resistant Depression

atai Life Sciences announced the U.S. FDA cleared an Investigational New Drug (IND) to conduct a clinical drug-drug interaction (DDI) study of PCN-101 (R-ketamine). atai plans to initiate the study early this year through its platform company Perception Neuroscience. The DDI study is designed to evaluate the pharmacokinetics of PCN-101 when used concurrently with other drugs and will advance alongside a recently initiated Phase 2a trial in treatment-resistant depression (TRD) based in Europe.

The open-label, 2-cohort, fixed-sequence, drug-drug interaction study will evaluate the effects of CYP450 inhibition on the pharmacokinetics of PCN-101 in healthy adult subjects. atai will use the results of this study in conjunction with clinical pharmacokinetic data to advance the development of PCN-101 in TRD.

Additionally, atai anticipates running a bioavailability study in 2022, which is designed to bridge the IV formulation to a subcutaneous formulation of PCN-101, supporting the potential for self-administration.

Perception Neurosciences reported data from a phase 1 trial in February of 2021.  In this study, PCN-101 was safe and well-tolerated at all doses up to 150 mg, the hi...

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