Incannex Reports Positive Results from Phase 2 Clinical Trial of PSX-001 (Psi-GAD) for Generalised Anxiety Disorder

Core Insights - Incannex Healthcare Inc. reported positive results from its Phase 2 clinical trial of PSX-001, a psilocybin-assisted therapy for Generalised Anxiety Disorder (GAD), indicating its potential as a leading treatment globally [1][12] Trial Design Overview - The Phase 2 study was randomized, double-blind, and placebo-controlled, enrolling 73 adults with moderate to severe GAD, who received either a 25 mg dose of synthetic psilocybin or placebo [2] - Participants underwent two dosing sessions with equal psychological support, ensuring treatment effects were attributable to psilocybin [2] Efficacy Results - The trial demonstrated statistically significant improvements across all primary and secondary endpoints, with a notable 12.8-point reduction in HAM-A scores for the Psi-GAD group compared to a 3.6-point reduction in the placebo group (p<0.0001) [4] - A clinically meaningful response was observed in 44.1% of patients treated with Psi-GAD, achieving a ≥50% reduction in HAM-A scores, significantly higher than the placebo group [5] - The Psi-GAD group also showed a 7.4-point reduction in GAD-7 scores versus 3.5 points for placebo (p<0.0004) [7] - Improvements in functional impairment were noted with a 6.0-point reduction in SDS scores for Psi-GAD compared to 1.3 points for placebo (p<0.007) [8] - Statistically significant antidepressant effects were observed with a 3.9-point reduction in PHQ-9 scores for Psi-GAD versus 0.3 points for placebo (p<0.005) [9] - Quality of life, measured by the PWI, improved by 10.6 points in the Psi-GAD group compared to 2.7 points for placebo (p<0.002) [10] Safety and Tolerability - Treatment with Psi-GAD was well tolerated, with no serious adverse events reported and only one withdrawal from the trial [11] - Most treatment-emergent adverse events were mild to moderate and transient, with no increased risks of suicidality or psychosis noted [11] Company Statements - Dr. Lou Barbato, Chief Medical Officer, emphasized the statistically significant and durable treatment effects observed across multiple measures, positioning Psi-GAD as a leader in anxiety treatment innovation [12] - Joel Latham, President and CEO, highlighted the results as a major milestone for Incannex, reinforcing confidence in their clinical pipeline and strategy [13] Next Steps - Incannex is preparing to initiate a multi-jurisdiction Phase 2 clinical trial and is refining formulation strategies to strengthen its intellectual property position [14][16]