Incannex Healthcare Ltd (ASX:IHL, NASDAQ:IXHL) has appointed two highly experienced lead principal investigators (PIs) for its Phase 2/3 clinical trial of IHL-42X, a treatment for obstructive sleep apnoea (OSA).
Crucial role in trials
The investigators, Dr. John D Hudson of FutureSearch Trials of Neurology in Austin, Texas, and Dr. Russell Rosenberg of Neurotrials Research Inc in Atlanta, Georgia, will play a crucial role in the trial.
They will oversee the first clinical trial sites, handle submissions to the FDA, and obtain ethics approval from Institutional Review Boards.
Incannex plans to recruit some 45 sites across multiple jurisdictions for this significant trial.
Dr. John D Hudson, serving as the Principal Investigator for FutureSearch Trials of Neurology, has extensive experience supervising more than 300 clinical trials related to neurological and sleep disorders, and is recognised nationally and internationally as a speaker on these topics.
FutureSearch Trials operates clinical research facilities in Austin and Dallas, Texas, focusing on studies related to neurological, pain, and sleep disorders, including an on-site sleep lab.
“Clinical trials for novel formulations of medication are newsworthy for any specialty and sleep medicine is no exception,” Dr Hudson said.
“Obstructive sleep apnoea, 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.”
Decades of clinical sleep research
Dr. Russell Rosenberg, CEO of Neurotrials Research Inc, has more than 35 years of experience in clinical sleep medicine and research. He has been involved in numerous clinical trials, including 14 related to OSA and 211 focused on other sleep disorders.
“Incannex has developed a sound, rational, scientific protocol to determine the efficacy and safety of IHL-42X in subjects with obstructive sleep apnea," Dr Rosenberg said.
"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 apnoea 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.”
Incannex CEO and managing director Joel Latham added:
“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. 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.”