Atai's Clinical Results Of R-Ketamine For Depression: Road To Subcutaneous At-Home Administration

Clinical-stage biopharma company atai Life Sciences ATAI shared results from majority-owned subsidiary Perception Neuroscience’s Phase 1 intravenous-to-subcutaneous bridging study of its proprietary R-ketamine compound PCN-101.

See Also: Breaking Ground In Prevention & Relief Of Anxiety & PTSD: Silo Pharma' Nasal Formulation For Ketamine-Based Treatment

This single isomer of ketamine belongs to a new generation of glutamate (NMDA) receptor modulators with the potential for rapid-acting antidepressant activity and anti-suicidal effects. Preclinical studies suggest it could possess more durable effects compared to S-ketamine, and a more favorable safety and tolerability profile.

The Phase 1 open-label, four-period crossover study assessed the safety, tolerability and pharmacokinetic profile of 60mg, 90mg and 120mg of PCN-101 delivered subcutaneously (SQ) as compared to 60mg delivered intravenously (IV). 16 healthy volunteers participated, each into one of four administration sequences.

The study’s design points at informing dosing regimens of the new SQ formulation toward optimizing the balance of safety, tolerability and efficacy of PCN-101 in future studies, supporting further studies on the potential of R-ketamine as a rapid acting antidepressant for at-home use.

Results showed: 

• 120mg of PCN-101 delivered SQ almost doubled drug exposure while maintaining the nearly same maximum concentration as the 60mg IV dose.

• PCN-101 was generally well-tolerated, and no serious adverse events were reported. At the 60mg IV dose, rates of sedation and dissociation reflected that of prior studies; at the newly-assessed 120mg SQ dose, rates were each 14%.

• Although limited, the study shows a favorable safety and tolerability profile compared to Johnson & Johnson's JNJ Spravato’s regarding rates of sedation and dissociation, reportedly ranging between 50-61% and 61-69%. 

• Altogether, researchers believe the data supports the concept of at-home use of PCN-101 in future studies.

atai continues to work with Perception Neuroscience to explore strategic partnership options.

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Photo: Benzinga edit with photo by True Touch Lifestyle and Gorodenkoff by Shutterstock and Doc James by Wikimedia Commons.