Incannex reports positive Phase 2 trial results for PSX-001 in Generalised Anxiety Disorder.

Incannex Healthcare reports positive results from its Phase 2 clinical trial of PSX-001 (formerly Psi-GAD), a psilocybin-assisted psychotherapy treatment for Generalized Anxiety Disorder (GAD). The trial confirmed statistically significant and clinically meaningful improvements across every key endpoint assessed. The treatment has shown potential as a best-in-class therapy for patients with moderate to severe GAD.

Incannex Healthcare Inc. (NASDAQ: IXHL) has announced positive results from its Phase 2 clinical trial of PSX-001 (formerly Psi-GAD), a psilocybin-assisted psychotherapy treatment for Generalized Anxiety Disorder (GAD). The trial, conducted with 73 adult participants, demonstrated statistically significant and clinically meaningful improvements across all key endpoints assessed. The results reinforce PSX-001's potential as a best-in-class therapy for patients with moderate to severe GAD.

The randomized, double-blind, placebo-controlled study showed a 12.8-point reduction in HAM-A scores for patients treated with PSX-001 compared to a 3.6-point reduction in the placebo group (p0.0001). This significant difference was sustained over an 11-week follow-up period, indicating a rapid onset and durable treatment effect. The treatment also resulted in a 44.1% clinical response rate and 27% remission rate, more than four and five times higher than the placebo group, respectively.

PSX-001 demonstrated efficacy across multiple validated measures of anxiety severity, functional disability, depression, and quality of life. The treatment showed no serious adverse events and only one withdrawal from the 73 participants, highlighting its strong safety profile.

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 position.

The results of the Phase 2 trial for PSX-001 represent a significant breakthrough in the psychedelic medicine space. The trial's robust efficacy and safety profile position PSX-001 as a leading candidate in the development of psilocybin-assisted therapies for anxiety disorders globally.

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