Incannex has engaged Fortrea (NASDAQ: FTRE) as the contract research organisation (CRO) for management of the IND opening Phase 2/3 clinical trial investigating IHL-42X for treatment of obstructive sleep apnoea (OSA).

Incannex Healthcare (ASX:IHL) said the Phase 2/3 clinical trial will assess the safety and efficacy of IHL-42X at the best performing two doses from its successful proof-of-concept clinical trial, in patients with OSA who are intolerant, non-compliant, or naïve to positive airway pressure, over a 52-week treatment period.

Participants will receive one of its novel cannabinoid combination drug IHL-42X, dronabinol, acetazolamide or placebo for the entirety of the study.

All participants will complete daily surveys on their sleep quality, attend monthly clinic visits to assess functional outcomes of sleep, cognitive function and other measures of safety and efficacy.

Every three months, an overnight polysomnography will be conducted on participants to determine the effect of treatment on the patients’ Apnea Hypopnea Index score (AHI), which is the main measure of OSA required for diagnosis.

All drug treatments will be compared to placebo.

IHL is targeting 45 clinical trial sites to be included in the study after receiving interest from 63 different clinics to be part of the trial in international locations.

The company said Fortrea will use its high-value data sets, combined with its technology enabled clinical trial solutions to improve study recruitment, reduce study risk, safeguard data quality, and gain operational insights as the trial progresses.

Need for pharmaceutical solution to OSA

OSA is the most common sleep-related breathing disorder. It involves the narrowing of the upper airway during sleep, interfering with a person’s breathing, decreasing oxygen uptake, resulting in poor-quality sleep.

Untreated OSA leads to serious long-term adverse health outcomes including hypertension, cardiovascular disease, heart attack, cognitive impairments, anxiety and depression, irritability and daytime fatigue increasing the risk of accidents.

There are currently no drug treatments available for OSA, which is surprising given the prevalence of the affliction.

The current treatment standard of care is a Continuous Positive Airway Pressure (CPAP) machine. However, patient compliance to CPAP is quite poor due to various factors related to discomfort.

The global annual market for OSA detection and treatment using CPAP and other breathing aids is ~US$10 billion per annum and growing.

OSA is highly prevalent, affecting ~30 million adults in the US alone. It is estimated that the annual economic burden of undiagnosed sleep apnoea among US adults is ~US$149.6 billion per annum.

These costs include US$86.9 billion in lost productivity, US$26.2 billion in motor vehicle accidents and US$6.5 billion in workplace accidents.

IHL-42X, developed by Incannex, is a synergistic composition of dronabinol, a synthetic form of tetrahydrocannabinol (THC), and acetazolamide, a carbonic anhydrase inhibitor.

The Phase 2 proof of concept clinical trial observed that IHL-42X reduced average
AHI by an average of 50.7% versus baseline assessments with 25% of participants experiencing greater than an 80% reduction in the AHI.

No serious treatment emergent adverse events were reported during the clinical trial. Furthermore, THC concentrations in blood were below the limits for impaired driving the morning after nocturnal dose administration of IHL-42X.

Approaching trial with confidence

IHL CEO and managing director Joel Latham said the initial Phase 2 proof of concept
clinical trials were “truly remarkable” and now allows for the Phase 2/3 trial to be a genuine long-term safety and efficacy trial.

“If we again observe such remarkable drug efficacy, safely administered over the 52 weeks, Incannex is confident that our product will be marketable,” he said.

Latham said Fortrea has been a valuable partner to IHL for a long time over multiple projects and the company has full confidence that its team will successfully manage trials.

“Fortrea’s familiarity with the study and established relationships with potential trial sites will expedite the study start up and site engagement activities,” he said.

Meanwhile, IHL last week announced it has been given the green light to start its Phase 2 clinical trial to assess the safety and efficacy of IHL-675A for rheumatoid arthritis.

IHL received approval from a Human Research Ethics Committee (HREC) to commence the Phase 2 trial from the lead site Emeritus Research in Melbourne.

This article was developed in collaboration with Incannex Healthcare, a Stockhead advertiser at the time of publishing.  

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.