Incannex announces Phase 2 trial of PSX-001 met every key endpoint

Incannex (IXHL) Healthcare reports positive data from its Phase 2 clinical trial of PSX-001, a psilocybin-assisted psychotherapy treatment for Generalised Anxiety Disorder, GAD. The results confirm statistically significant and clinically meaningful improvements across every key endpoint assessed in the study, reinforcing PSX-001’s potential as a best-in-class therapy for patients with moderate to severe GAD. The Phase 2 trial of Psi-GAD demonstrated a consistent pattern of efficacy, delivering statistically significant and clinically meaningful improvements across all primary and secondary endpoints: HAM-A: Patients treated with Psi-GAD achieved an average 12.8-point reduction in HAM-A scores from baseline, compared to a 3.6-point reduction in the placebo group. Clinical Response and Remission: Psi-GAD treatment resulted in a clinically meaningful response, corresponding to a reduction in HAM-A score from baseline of greater than or equal to50% in 44.1% of patients. GAD-7: The Psi-GAD group recorded an average 7.4-point reduction in GAD-7 scores, compared to a 3.5-point reduction for placebo. SDS: Patients in the Psi-GAD group experienced a 6.0-point reduction in SDS scores, versus 1.3 points in the placebo group-a statistically significant improvement. PHQ-9: Psi-GAD also showed statistically significant antidepressant effects, with a 3.9-point reduction in PHQ-9 scores compared to just 0.3 points in the placebo group. PWI: Quality of life, as measured by the PWI, improved by an average of 10.6 points in the Psi-GAD group versus 2.7 points for placebo-a statistically significant difference.