Incannex Healthcare has recruited two highly experienced lead principal investigators (PIs) for the IND opening Phase-2/3 clinical trial investigating IHL-42X cannabinoid treatment of obstructive sleep apnoea (OSA).

The company has appointed Dr John D Hudson of FutureSearch Trials of Neurology, Austin, Texas and Dr Russell Rosenberg of Neurotrials Research Inc, Atlanta, Georgia.

It’s a critical step for the study as Dr Hudson and Dr Rosenberg (and their associated facilities) will serve as the first clinical trial sites for submission to the FDA and for ethics approval from Institutional Review Boards.

“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,” Incannex (ASX:IHL) CEO and MD Joel Latham said.

“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.” 

Potentially life-changing oral medication option

Dr Hudson has supervised over 300 clinical trials over the past 20 years mostly related to neurological issues, and founded the Austin Neurological Clinic and Sleep Medicine Consultants.

He said that obstructive Sleep Apnea affects millions of people, and remains under-treated, 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,” Dr Hudson said.

“This is more than exciting, it could prove to be life-changing for many patients.”

A positive addition to the treatment landscape

Dr. Rosenberg is currently Chief Science Officer and CEO of NeuroTrials Research in Atlanta, Georgia and has more than 35 years’ 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.

“Many sleep apnea patients cannot adhere to positive airway pressure therapy, use it for an inadequate period at night or just refuse it,” he said.

“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.”

This article was developed in collaboration with Incannex Healthcare Limited, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.