FDA Clears Incannex To Proceed With Phase 2 Psilocybin-Assisted Therapy Trial For Anxiety
As reported in a recent press release, Incannex Healthcare Inc. (NASDAQ:IXHL) has received approval from the U.S. Food and Drug Administration to proceed with a phase 2 clinical trial investigating its psilocybin formulation, PSX-001, combined with psychotherapy for treating generalized anxiety disorder (GAD). This follows the successful review of the company’s Investigational New Drug (IND) application, which detailed the clinical trial protocol and the safety and quality of the investigational drug product.
Previous Positive Results
The trial, named PsiGAD2, builds on the positive results of the initial PsiGAD1 proof-of-concept study conducted at Monash University in Melbourne. PsiGAD1 demonstrated a significant 12.8-point reduction in the Hamilton Anxiety Rating Scale (HAM-A) scores from baseline in the psilocybin treatment group, highlighting the potential of psilocybin-assisted psychotherapy in reducing anxiety symptoms.
Phase 2 Trials
PsiGAD2 aims to replicate …