Incannex Healthcare Inc. (Nasdaq: IXHL) announced positive data from its Phase 2 clinical trial of PSX-001 for Generalised Anxiety Disorder (GAD). The results show statistically significant and clinically meaningful improvements across various measures.
The trial enrolled 73 adult participants with moderate to severe GAD and demonstrated exceptional efficacy of PSX-001. The treatment showed significant improvements in anxiety, mood, disability, quality of life, and overall wellbeing.
PSX-001's success in the clinical trial positions it as a leading psilocybin-assisted therapy globally, offering hope for patients with GAD.
Exceptional Efficacy Results
PSX-001 (Psi-GAD) showed statistically significant and clinically meaningful improvements across all primary and secondary endpoints, showcasing its potential as a best-in-class therapy for moderate to severe GAD patients.
Clinical Response and Remission
Psi-GAD treatment led to a clinically meaningful response in 44.1% of patients and full disease remission in 27%, significantly higher than the placebo group.
Safety and Tolerability
Treatment with Psi-GAD was well-tolerated with no serious adverse events reported, underlining the safety profile of the therapy.
- The Phase 2 trial of Psi-GAD demonstrated remarkable efficacy in reducing anxiety symptoms, improving functional impairment, and enhancing quality of life for GAD patients.
- The positive results from the trial highlight the potential of PSX-001 as a promising psilocybin-assisted therapy for the treatment of Generalised Anxiety Disorder.
The successful Phase 2 trial of PSX-001 marks a significant milestone for Incannex Healthcare Inc., reinforcing the company's commitment to developing innovative therapies for mental health disorders like GAD.