Incannex Healthcare Ltd, a clinical-stage pharmaceutical company developing medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies, has recruited two lead principal investigators for the Investigational New Drug opening phase 2/3 clinical trial investigating IHL-42X, a cannabinoid combination product, for the treatment of obstructive sleep apnea (OSA).
John D. Hudson, MD, principal investigator for FutureSearch Trials of Neurology, and Russell Rosenberg, PhD, chief science officer and CEO of Neurotrials Research Inc, were selected.
“Our company is delighted to have the endorsement of two leading esteemed research scientists with the relevant experience to advance our IHL-42X drug candidate,” says Incannex CEO and managing director Joel Latham in a release. “Their support is testament to the efficacy of IHL-42X demonstrated in phase 2 proof of concept studies. The multi-site clinical trial being arranged is a pivotal trial, meaning that it can be used for the registration of IHL-42X for regulatory registration and commercial launch, which is an exciting development for Incannex after much hard work and dedication from our broad team of contributors.”
Recruiting the lead principal investigators is a critical step for the Investigational New Drug opening phase 2/3 study as Hudson and Rosenberg, and their associated facilities, will serve as the first clinical trial sites for submission to the US Food and Drug Administration and for ethics approval from Institutional Review Boards. Site recruitment and selection in the US and other jurisdictions is an iterative process, according to a release from Incannex, which plans to recruit approximately 45 sites across multiple jurisdictions for this pivotal trial.
Hudson, board certified in neurology and sleep medicine, has supervised over 300 clinical trials over the past 20 years, mostly related to neurological and sleep disorders, and has been a national and international speaker for these disorders.
FutureSearch Trials consists of two clinical research facilities in Austin and Dallas, Texas, which have been in operation for over 15 years. The Austin site where Hudson is the principal investigator focuses on clinical research studies for the treatment of neurological, pain, and sleep disorders and features an on-site sleep lab.
Regarding the IHL-42X trial, Hudson says in a release, “Clinical trials for novel formulations of medication are newsworthy for any specialty, and sleep medicine is no exception. Obstructive sleep apnea, affecting millions of people, remains under-treated. This is due in part to patients not being diagnosed, and in part due to poor patient compliance with current therapeutic modalities. While unheard of a few years ago, oral medications to help reduce the cause of OSA, are now undergoing further investigation. This is more than exciting, it could prove to be life-changing for many patients.”
Rosenberg has more than 35 years of experience in clinical sleep medicine and research, acting as an investigator in over 300 clinical trials including 14 in OSA and 211 in other sleep-related disorders. He is a board-certified sleep specialist and fellow of the American Academy of Sleep Medicine. Rosenberg is former chair and spokesperson for the National Sleep Foundation and has appeared frequently on local and national television news shows including the Today Show, Good Morning America, CNN, and MSNBC.
Neurotrials Research Inc is a clinical research facility in Atlanta that has been in operation for over 25 years. Neurotrials Research is focused on delivery of trials in neurology/central nervous system and sleep indications.
Regarding the IHL-42X phase 2/3 clinical trial, Rosenberg says in a release, “Incannex has developed a sound, rational, scientific protocol to determine the efficacy and safety of IHL-42X in subjects with obstructive sleep apnea. Many sleep apnea patients cannot adhere to positive airway pressure therapy, use it for an inadequate period at night, or just refuse it. Having a safe, effective pharmacological option for obstructive sleep apnea will be a positive addition to the treatment landscape as it will offer those that struggle to adhere to positive airway pressure therapy an alternative therapy.”