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- Incannex Healthcare (IHL) has made several advances in the protocol for its clinical trial of IHL-42X in patients with Obstructive Sleep Apnoea (OSA)
- The clinical-stage cannabinoid development company has partnered with The Alfred Hospital in Melbourne, where the Phase 2b trial will be conducted
- Professor Terence O’Brien, who has worked as the principal investigator on more than 100 clinical trials, has been appointed as the Principle Investigator
- Incannex has also contracted Novotech to ensure the IHL-42X clinical trial meets the requirements of the U.S. Food and Drug Administration
- Company shares are up 6.24 per cent to 6.6 cents each
Incannex Healthcare (IHL) has advanced the protocol for its clinical trial of IHL-42X in patients with Obstructive Sleep Apnoea (OSA).
The clinical-stage cannabinoid development company has partnered with The Alfred Hospital in Melbourne, where the Phase 2b trial will be conducted.
The primary endpoint of the clinical trial is the improvement in Apnea-Hypopnea Index (AHI), used as a measure of the severity of OSA. The secondary endpoints will include any reduction in the oxygen desaturation index, daytime somnolence, improvements in mood and safety of IHL-42X.
Incannex Healthcare Managing Director and CEO Joel Latham said the company is delighted to have secured the partnership with The Alfred after the COVID-19 pandemic cast doubt on the involvement of hospitals.
“The onset of COVID-19 and the ensuing lockdown that occurred in March of 2020 threw doubt over the ability of hospitals to be involved in any clinical trial activities.
“As a result, the Board of Incannex was determined to push forward with its trial and initially designed the trial around participants using portable measuring devices that, once fitted under the instruction of a sleep specialist, could be worn at home and feed data back to a central hub,” he said.
“However, as restrictions began to ease and appropriate trial management protocols were put in place, the participation of hospitals in clinical trial activity became clearer, and the company identified The Alfred as being the ideal partner in the IHL-42X trial.
“After the recent protocol changes, each patient will have their own room for the sleep study, adhering to social distancing rules. The company has also been advised by its regulatory consultants that its newly designed trial in partnership with The Alfred will provide a more robust and comprehensive trial, which will be important in its pursuit of registration under the FDA 505b(2) pathway,” he explained.
The Principle Investigator for the trial has also been named as the Neuroscience Clinical Trials Unit at The Alfred Hospital Professor Terence O’Brien who has worked as the principal investigator on more than 100 clinical trials.
“Professor O’Brien is a highly experienced medical clinician and clinical trial investigator. He lends strong credibility to our study, which is important due to our goal of making a new drug application with the FDA for drug registration, subject to ongoing clinical success,” Latham said.
Additionally, Incannex has contracted Novotech to ensure the IHL-42X clinical trial meets the requirements of the U.S. Food and Drug Administration.
The contracted research organisation will ensure the integrity of the program in terms of site management, data collection, analysis and safety monitoring.
Incannex also intends to submit the trial protocol to the Alfreds Health Ethics Committee by July 27, 2020, the next registration deadline for review.
Company shares are up 6.24 per cent to 6.6 cents each at 3:40 pm AEST.
