Incannex's PSX-001 Trials Show Positive Results for GAD Treatment

Incannex Healthcare reports positive data from its Phase 2 clinical trial of PSX-001, a psilocybin-assisted psychotherapy treatment for Generalized Anxiety Disorder. The trial met every key endpoint, with statistically significant and clinically meaningful improvements across all primary and secondary endpoints, reinforcing PSX-001's potential as a best-in-class therapy for moderate to severe GAD.

Incannex Healthcare (NASDAQ: IXHL) has announced positive results from its Phase 2 clinical trial of PSX-001, a psilocybin-assisted psychotherapy treatment for Generalized Anxiety Disorder (GAD). The randomized, double-blind, placebo-controlled study involving 73 adult participants showed statistically significant improvements across all endpoints.

The primary endpoint, HAM-A (Hamilton Anxiety Rating Scale) scores, saw a 12.8-point reduction in the PSX-001 group compared to a 3.6-point reduction in the placebo group (p0.0001). This difference is substantial and exceeds the threshold for clinical meaningfulness. Additionally, 44.1% of patients in the PSX-001 group achieved clinical response (a reduction in HAM-A score of ≥50%), and 27% reached full disease remission, compared to 9.6% and 4.8% in the placebo group, respectively.

The trial also demonstrated statistically significant improvements in other validated measures of anxiety severity, functional disability, depression, and quality of life. These results suggest that PSX-001 addresses the complex symptomatology of anxiety disorders more comprehensively than conventional treatments. The treatment effect was durable, with improvements sustained over an 11-week follow-up period.

The safety profile of PSX-001 was notable, with no serious adverse events reported and only one participant withdrawing from the trial. The majority of treatment-emergent adverse events were mild to moderate and consistent with the expected pharmacological effects of psilocybin.

Incannex plans to advance to multi-jurisdiction Phase 2 clinical trials and is exploring strategic partnerships to accelerate PSX-001's development. The company has an open Investigational New Drug (IND) application with the U.S. FDA and is refining formulation strategies to ensure a robust intellectual property (IP) position.

References:
[1] https://www.stocktitan.net/news/IXHL/incannex-reports-positive-results-from-phase-2-clinical-trial-of-psx-00xipkppqr4b.html