Business
FDA Review of PsiGAD2 IND complete; clinical trial for Psilocybin Assisted Psychotherapy in Patients with Generalised Anxiety Disorder to Proceed
Approval from FDA to proceed with 94 patient Phase 2 clinical trial received following review of IND dossier containing information on the clinical trial, as
About this update from Incannex Healthcare Inc.
[{"type":"text","content":"Approval from FDA to proceed with 94 patient Phase 2 clinical trial received following review of IND dossier containing information on the clinical trial, as well as safety and quality of the investigational drug product.PsiGAD2, short for Psilocybin for Generalised Anxiety Disorder trial two, follows the PsiGAD1 proof of concept trial, which demonstrated a 12.8 point reduction in the Hamilton Anxiety Rating Sacle (HAM-A) score from baseline in the psilocybin treatment group.\n NEW YORK and MELBOURNE, Australia, Aug. 05, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (‘Incannex’ or the ‘Company’), a clinical-stage pharmaceutical company developing proprietary medicinal cannabinoid products and psychedelic assisted psychotherapies is pleased to announce that it has received approval from the US Food and Drug Administration (‘FDA’) to conduct the Company’s Investigational New Drug (‘IND’) opening Phase 2 clinical trial. The trial will investigate Incannex’s psilocybin pharmaceutical formulation, known as PSX-001, in conjunction with psychotherapy in patients with generalised anxiety disorder in the United States and the United Kingdom.\n Incannex submitted the IND application on 26 June 2024 and the FDA completed their review of the application package during the allocated 30-day period. Incannex received communication that the FDA review was completed, and the IND-opening clinical trial, PsiGAD2, is deemed safe to proceed following assessment of the trial protocol, lead trial investigator, and a risk benefit analysis of the trial and prospective drug product.\n PsiGAD2 will recruit approximately 94 patients with generalised anxiety disorder, including those currently being treated with selective serotonin reuptake inhibitors, who meet the study inclusion and exclusion criteria. Patients will receive one of two dose strengths of PSX-001 under double blind conditions. There will be two dosing sessions for all patients as well as preparatory and integration sessions to facilitate psychotherapy.\n The primary endpoint for the study will be change in HAM-A score, a widely used and validated measure of anxiety, two weeks after completion of the second dosing session. HAM-A scores will be collected at predefined intervals for 23 weeks after completion of the dosing sessions and the change from baseline assessed a...