Medcan and psychedelic pharmaceutical company Incannex Healthcare (NASDAQ: IXHL) has filed a provisional patent application directed to the use of lead drug IHL-42X for the treatment of obstructive sleep apnea (OSA).
The application is the latest in the company’s ongoing commercial strategy to accrue a series of patent families across the development, manufacture and use of its drug candidates.
IHL-42X was designed to combine two drugs — tetrahydrocannabinol (THC or dronabinol) and acetazolamide — with therapeutic effects on OSA that act via different mechanisms.
Acetazolamide induces metabolic acidosis, raises the drive to breathe and reduces the sensitivity of body system that controls breathing, which lowers the incidence and severity of apneas and hypopnoeas.
Dronabinol is believed to activate muscles in the upper airway during sleep, thereby reducing the incidence of airway collapse.
Incannex previously discovered that the two drugs act synergistically to reduce the apnea hypopnea index (AHI) in patients with OSA.
Proof-of-concept trial assessment
Incannex has engaged Monash University associate professor of physiology Dr Brad Edwards to further assess the polysomnography data from a phase 2 proof-of-concept clinical trial investigating the effect of IHL-42X on OSA.
Dr Edwards is an expert on the mechanisms of OSA, having contributed to the development of a method to characterise its underlying causes (or endotypes).
Working with principal investigator Dr Jen Walsh and her research team at the University of Western Australia, Dr Edwards and his team have been able to characterise the effects of IHL-42X on OSA’s different endotypes.
IHL-42X was shown to have a dose-dependent effect on loop gain, whereby a low dose showed a “statistically significant improvement” in airway collapsibility.
Incannex managing director Joel Latham said the efficacy of low dose IHL-42X in the proof-of-concept trial had been an ideal outcome for the company.
“Low dose IHL-42X encompasses low doses of THC and acetazolamide such that the side effect profile was observed to be similar to that of the placebo arm,” he said.
“IHL-42X did not have a significant effect on the arousal threshold (propensity to wake up from sleep) at any dose [which] sheds an important light on the drug’s mechanism of action … the relationship between OSA endotypes and response to IHL-42X is useful in identifying patients who will best respond to treatment as set out in the provisional patent application.” Ultimately, this means that Incannex may find its best use for IHL-42X in a particular cohort of patients.
Incannex is currently preparing for another clinical trial into IHL-42X and is also working on opening an investigational new drug application with the US Food and Drug Administration (FDA).