Incannex has announced positive results from a phase 2 clinical trial investigating the effects of a cannabis-based formulation on the treatment of obstructive sleep apnoea.
The clinical-stage pharmaceutical company Incannex has revealed promising results from a phase 2 proof-of-concept clinical trial investigating its cannabis-based formulation IHL-42X for the treatment of obstructive sleep apnoea. The findings showed that IHL-42X reduced apnoea hypopnoea index (AHI), improved patient-reported sleep quality and was well tolerated among test subjects.
AHI is a measure of the number of times per hour a subject’s airway is blocked (apnoea) or partially blocked (hypopnoea). It is the main criteria used to diagnose and monitor sleep apnoea.
Incannex, which develops medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies, found that a low dose was most effective at reducing AHI. Researchers said this is encouraging for the future of the treatment as a lower dose will reduce risks of side effects and the cost of goods.
The study was conducted at the University of Western Australia Centre for Sleep Science and The Alfred Hospital. A total of eleven participants were recruited for the study and ten participants completed treatment periods.
The clinical trial assessed three doses of IHL-42X at reducing the AHI in patients who suffered from the condition. Data was also collected for other aspects of sleep quality, THC clearance and safety.
Trial participants received each of the three doses of IHL-42X and placebo across four seven-day treatment periods, separated by one week washout periods. At the end of each treatment period, they attended the clinic for an overnight sleep study where AHI was determined, along with other measures of sleep quality, quality of life and drug safety.
The researchers found that breathing was interrupted less frequently during sleep in subjects taking IHL-42X. The company said this supports its hypothesis that the formulation is an effective treatment for the common sleep condition and provides confidence that IHL-42X will meet the FDA’s criteria.
The Australian company met with the FDA last month for a “highly constructive” Pre-Investigational New Drug Application (pre-IND) meeting with the US Food and Drug Administration to discuss the development of IHL-42X. In a decision that will save Incannex time and cost, FDA agreed that the firm does not need to conduct studies on animals.
Chief Scientific Officer for Incannex, Dr Mark Bleackley, said: “The FDA’s interest in IHL-42X as a potential therapy for OSA was extremely encouraging.
“The feedback they provided on the overall proposed development program was positive. The agency’s responses to the specific questions we posed allow us to revise our clinical trial protocols to ensure that we are running highly efficient studies that generate the type and amount of data the FDA will require in a future marketing application. The results from the pre-IND meeting will shape the IHL-42X development program over the coming months.”
