Positive pre-IND meeting with US FDA and ethics approval to commence Phase 2a Psi-GAD clinical trial: psilocybin-assisted psychotherapy for Generalised Anxiety Disorder

Clinical stage pharmaceutical development company, Incannex Healthcare Limited (ASX: IHL, ‘Incannex’ or the ‘Company’), is pleased to announce:
1. that the Phase 2a Psi-GAD clinical trial, led by Dr Paul Liknaitzky at Monash University, has received approval to proceed from the Monash University Human Research Ethics Committee (MUHREC); and
2. the completion of its pre-Investigational New Drug Application (‘pre-IND’) meeting with the US Food and Drug Administration (‘FDA’) regarding the Company’s clinical development program comprising psilocybin-assisted psychotherapy for Generalised Anxiety Disorder (‘GAD’).