Medicinal cannabinoid pharmaceutical product developer Incannex Healthcare Limited (ASX: IHL) has filed a provisional patent application directed to the use of IHL-42X for the treatment of Obstructive Sleep Apnoea (OSA).
With this latest provisional patent application, Incannex intends to pursue additional patent protection for its IHL-42X clinical programme, consistent with the company’s ongoing commercial strategy to accrue a patent position across the development, manufacture, and use of the company’s 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 helps to reduce the incidence and severity of apnoeas and hypopnoeas.
Dronabinol is believed to activate muscles in the upper airway during sleep, thereby reducing incidence of airway collapse. Incannex previously discovered that the two drugs act synergistically to reduce the Apnea Hypopnea Index (AHI) in patients with OSA.
Incannex engaged Dr Brad Edwards, Associate Professor of Physiology at Monash University, to further assess the polysomnography data from the Company’s Phase 2 proof-of-concept clinical trial that investigated the effect of IHL-42X on OSA.
Dr Edwards is an expert on mechanisms of OSA, having contributed to the development of a method to characterise the underlying causes (or endotypes) of OSA. Working in collaboration with the Phase 2 trial’s principal investigator, Dr Jen Walsh and her team at the University of Western Australia, Dr Edwards and his team have characterised the effects of IHL-42X on the different endotypes of OSA.
IHL-42X was shown to have a dose dependent effect on loop gain. Low dose IHL-42X showed a statistically significant improvement in airway collapsibility. This validates why low dose IHL-42X was observed to be more effective than the medium or high doses.
The efficacy of low dose IHL-42X in the phase 2 proof of concept trial has 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. IHL-42X did not have a significant effect on the arousal threshold (propensity to wake up from sleep) at any dose.
These findings shed important light on the mechanism of action of IHL-42X. In particular, the relationship between OSA endotypes and response to IHL-42X is useful in identifying patients who will best respond to IHL-42X, as set out in the new provisional patent application.
Incannex works closely with its patent attorneys to build upon its competitive position through the ongoing development of intellectual property assets,” CEO and Managing Director, Joel Latham, said.
“Our intention is to build patent families around our drug candidates as we learn more about them through our research and development programs undertaken by our dedicated scientific teams.”
Incannex has previously filed International Patent Application No. PCT/AU2021/050734 as part of the IHL-42X development programme.