Company also announces its finalizing development of its PSX-001 psilocybin drug formulation.
Incannex Healthcare Inc., a biotechnology firm focused on cannabinoid and psychedelic medicine, has reported positive results from its Phase 2 Psi-GAD1 clinical trial investigating psilocybin as a treatment for generalized anxiety disorder (GAD).
The trial met its primary goal, showing a significant reduction in anxiety symptoms among participants who received psilocybin-assisted therapy compared to those who received a placebo, the company said in a Feb. 28 news release.
Developed in collaboration with the Clinical Psychedelic Lab at Monash University under the leadership of Dr. Paul Liknaitzky, the trial demonstrated that patients treated with psilocybin experienced a 12.8-point drop in the Hamilton Anxiety Rating Scale (HAM-A) from a baseline of 29.5 to 16.8 at week 11, six weeks after the final treatment session.
This reduction was 9.2 points greater than that observed in the placebo group, with a statistical significance (p<0.0001). Furthermore, 44% of the psilocybin-treated patients saw a reduction in anxiety scores by at least 50%, and 27% achieved full disease remission, indicating a more than fivefold increase over the placebo group’s remission rate.
The psilocybin treatment, coupled with psychotherapy, was also well-tolerated, with participants reporting only mild to moderate side effects. The safety profile was favorable, as there were no serious or severe adverse events reported, and only one participant out of 73 withdrew from the 7-week treatment program.
Following these results, Incannex is preparing to advance the psilocybin treatment into a multi-site Phase 2B trial in the United States and United Kingdom, the company said.
Meanwhile, the company is finalizing development of its PSX-001 psilocybin drug formulation. Incannex has begun the necessary steps for manufacturing this formulation under current Good Manufacturing Practice standards and plans to submit an investigational new drug application to the U.S. Food and Drug Administration.