MELBOURNE – Incannex Healthcare Inc. (NASDAQ:IXHL), a biotechnology firm focused on cannabinoid and psychedelic medicine, reported positive outcomes from its Phase 2 Psi-GAD1 clinical trial assessing psilocybin as a treatment for generalized anxiety disorder (GAD). The study, which was conducted in collaboration with Monash University's Clinical Psychedelic Lab, met its primary endpoint, with the psilocybin group experiencing a significant reduction in anxiety scores compared to the placebo group.
Patients treated with psilocybin exhibited a 12.8-point decrease in the Hamilton Anxiety Rating Scale (HAM-A) from baseline, a significant change compared to a 3.6-point reduction in the placebo group. Additionally, 44% of the psilocybin group achieved at least a 50% reduction in anxiety scores, and 27% reached full disease remission, rates that far exceed those observed with placebo.
The treatment, which combines psilocybin with psychotherapy, was well-tolerated, with only mild to moderate adverse events reported. These results were consistent with the known effects of psilocybin, and no severe adverse events were noted. The trial had a high retention rate, with only one participant out of 73 withdrawing from the 7-week program.
The successful trial has prompted Incannex to proceed with the development of its proprietary psilocybin formulation, PSX-001, and to prepare for a multi-site Phase 2B trial. The company is currently finalizing the cGMP manufacture of PSX-001 for clinical trial supply and plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA).
GAD is a prevalent disorder, affecting approximately 3% of the population annually in countries like Australia and the United States. Current treatments often fall short, with less than half of patients achieving remission and many experiencing relapses or side effects.
Incannex's announcement, based on a press release statement, highlights the potential of psilocybin-assisted therapy as a new avenue for treating GAD, a condition with limited effective pharmacotherapies. The company aims to improve the quality of life for millions affected by this disorder, pending regulatory approvals and further clinical success.
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