atai Life Sciences Releases Promising Results from PCN-101 Phase 1 Study, Offering Potential for Home-Based Use

LOS ANGELES– atai Life Sciences (NASDAQ: ATAI), a pioneering biotech company, has reported encouraging results from its Phase 1 investigation into the subcutaneous administration of PCN-101 (R-ketamine), facilitated through its subsidiary, Perception Neuroscience. The trial’s positive safety findings seem to pave the way for the continuation of the research.

The study, characterized by its open-label design and comprehensive four-phase crossover structure, was primed to assess the safety, tolerability, and pharmacokinetics of various PCN-101 dosages (60mg, 90mg, and 120mg) when administered subcutaneously. These findings were compared to the established 60mg intravenous (IV) administration of PCN-101. A group of 16 healthy participants was divided into four specific administration sequences for this evaluation.

The study’s primary objective was to derive insights into dosing strategies tailored to each subcutaneous formulation, with a spotlight on optimizing the therapeutic index—a crucial balance of safety, tolerability, and effectiveness. Achieving this balance is essential for unlocking PCN-101’s potential as a fast-acting antidepressant intended for home use.

Notably, at the 60mg IV dosage, the observed instances of sedation and dissociation mirrored previous studies on PCN-101 at similar dosages. The increased 120mg SQ dose demonstrated sedation and dissociation rates of 14% each, as determined by standardized assessment scores.

Of utmost significance, PCN-101’s administration was well-tolerated and free from severe adverse events.

atai Life Sciences observed that, in terms of safety and tolerability, PCN-101’s profile appears favorably comparable to the FDA-approved esketamine drug, Spravato. Previous research highlighted sedation and dissociation rates of 50% to 61% and 61% to 69% for Spravato, respectively.

These rates bear a resemblance to those recorded in the placebo groups of the earlier Phase 2 study on PCN-101 and clinical evaluations of Spravato for depression.

Overall, the results seem to bolster atai Life Sciences’ conviction that PCN-101 has a promising future in home-based therapeutic applications.