Incannex Healthcare Ltd (ASX:IHL, NASDAQ:IXHL) chief medical officer Dr Mark Bleakley speaks with Proactive after the company received clearance from the US Food and Drug Administration (FDA) to begin the Phase 2/3 clinical trial for its IHL-42X asset, designed to address obstructive sleep apnoea (OSA).
The clinical-stage pharmaceutical company developing proprietary medicinal cannabinoid products and psychedelic-assisted psychotherapies for unmet needs received the approval after submitting an Investigational New Drug (IND) application to the FDA last month. With the milestone approval in the bag, Incannex will proceed with the finalisation of institutional review board applications and submissions for the lead clinical trial sites.
Incannex is developing unique medicinal cannabis pharmaceutical products and psychedelic medicine therapies for the treatment of OSA, traumatic brain injury (TBI) and concussion, lung inflammation (ARDS, COPD, asthma, bronchitis), rheumatoid arthritis, inflammatory bowel disease, anxiety disorders, addiction disorders, and pain, among other indications.
US FDA approval and registration, subject to ongoing clinical success, is being pursued for each drug and therapy under development.
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Incannex Healthcare Ltd