Dr Mark Bleackley: New Medication to Benefit Patients With Obstructive Sleep Apnea

In the RePOSA study conducted by Incannex Healthcare Inc., IHL-42X demonstrated great promise in the treatment of obstructive sleep apnea (OSA). Currently in phase 2/3, IHL-42X, a medicinal cannabinoid pharmacotherapy, has showcased encouraging results for reducing the impact of OSA and improving perceptions of sleep quality in affected individuals. In a news release, Incannex explained that there are currently no registered pharmacotherapies available to patients, and when paired with poor compliance to positive airway pressure devices, many patients with OSA are left untreated or chronically under-treated. The development of IHL-42X, therefore, addresses a pressing unmet need in this patient population.

Mark Bleackley, PhD, chief scientific officer, Incannex, joined The American Journal of Managed Care® for an interview to discuss the progress of the clinical trials thus far and notable findings ahead of submission for FDA approval.

This transcript has been lightly edited.

Transcript

What would you say are the most important findings from your research thus far and what implications do these hold for affected patients?

So right now, we've completed a proof-of-concept study, a clinical trial in Australia. And that found that, in patients receiving IHL-42X, there was a statistically significant reduction in their apnea hypopnea index (AHI), which is the number of times per hour their breathing is either stopped or reduced. And that AHI, which is the apnea hypopnea index, is the measure that's used to diagnose and monitor sleep apnea. So, seeing that reduction was the most important result. The other component that was really important, or the other finding from that study that was important, was the patients were asked every night to rate their sleep satisfaction. So, how well they thought they slept, and while they were on the IHL-42X treatment periods, they were more likely to rate their sleep satisfaction as “good” or “very good” than during the placebo period. So, we're having a physiological effect on the AHI. But also, the patients are feeling better, they're perceiving that their sleep is improved while on our drug product.

And the next trial that we're running is really expanding on that proof-of-concept study. So that proof-of-concept study was run over a 7-night treatment period to get us some evidence as to whether the drug is working. Now, we'll expand in our phase 2/3 RePOSA study; the phase 2 is looking at identifying the optimal dose of IHL-42X. So, we'll compare 2 doses to placebo over a 28-day treatment period. Once we've selected that optimal dose based on the efficacy and the safety that we detect, that we record during that phase 2 study we'll select the optimal dose and take that forward to phase 3. So, the phase 2 will be done in 120 patients, and then the phase 3 with 440 patients, and that will extend the treatment period to 1 year, so 365 days, and we'll compare IHL-42X to each of the component drugs—to dronabinol which is the synthetic form THC, and acetazolamide, which is the partner active pharmaceutical ingredient in IHL-42X, and then the placebo as well. So that'll give us an idea of the contribution of each drug to the efficacy and the safety of IHL-42X and becomes a key part of not only understanding how the drug works, but also the regulatory submissions moving forward. So, an eventual submission to the FDA.