Incannex Healthcare Ltd (ASX:IHL, NASDAQ:IXHL), which specialises in medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies, has announced the submission of an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for its IHL-42X asset, designed to address obstructive sleep apnoea.
Essential step
Submitting an IND to the FDA is an essential step for pharmaceutical companies aiming to progress investigational drugs through the stages of development in the United States. The FDA review process involves a meticulous evaluation of the scientific, clinical, and safety aspects of the proposed clinical trial to ensure regulatory compliance.
This application marks a significant milestone for Incannex as it seeks regulatory approval, conducts clinical trials and engages in scientific dialogue with the FDA.
The IND dossier compiled by the Incannex team includes comprehensive modules that provide detailed information on the safety and efficacy of IHL-42X, as well as its component active pharmaceutical ingredients.
It also encompasses crucial data regarding the drug's development, manufacturing, quality, and stability.
The clinical protocol and investigator information for the opening clinical trial are also incorporated in the submission.
Trial will assess sleep outcomes
The trial will be a multi-centre Phase 2/3 study examining the effectiveness of IHL-42X for the treatment of obstructive sleep apnoea (OSA). It will span a 52-week treatment period and focus on patients with OSA who are either intolerant, non-compliant, or naïve to positive airway pressure.
Participants will receive one of the following treatments: IHL-42X, dronabinol, acetazolamide, or placebo.
Throughout the trial, participants will complete daily surveys on their sleep quality and attend monthly clinic visits to assess functional outcomes of sleep, cognitive function, and other measures of safety and efficacy.
Polysomnography will be conducted every three months to evaluate the effect of treatment on the patients' Apneoa Hypopnea Index score (AHI) and other sleep parameters. All drug treatments will be compared to placebo.
Highly experienced research clinicians
Leading this groundbreaking clinical trial are two highly experienced research clinicians: Dr. John Douglas Hudson and Dr. Russell Rosenberg. Dr. Hudson, a board-certified Neurologist and Sleep Medicine specialist, serves as the Principal Investigator for FutureSearch Trials of Neurology in Austin, Texas.
With over 20 years of experience supervising more than 300 clinical trials, Dr. Hudson has become a renowned national and international speaker in the field of neurological and sleep disorders.
Dr. Rosenberg, currently the Chief Science Officer and CEO of NeuroTrials Research in Atlanta, Georgia, boasts a doctorate in clinical and research psychology from The Ohio State University.
He has accumulated over 35 years of experience in clinical sleep medicine and research, participating in numerous clinical trials, including 14 focused on OSA and 211 related to other sleep disorders.