Incannex Approved For Bioavailability Clinical Trial For Dronabinol-Based Drug For Treatment Of Obstructive Sleep Apnea

Incannex Healthcare Limited IXHL IHL has received approval from Bellberry Human Research Ethics Committee to commence a bioavailability/bioequivalence (‘BA/BE’) clinical trial on IHL-42X, the company’s proprietary drug product for treatment of obstructive sleep apnea.

The BA/BE clinical trial will assess the pharmacokinetics and tolerability of the two active pharmaceutical ingredients (‘APIs’) in IHL-42X, dronabinol (‘THC’) and acetazolamide, compared to the respective FDA reference listed drugs, as well as the effect of food on pharmacokinetics of the two APIs.

The study will include 116 participants who will each complete four single dose treatment periods, being dosed with IHL-42X, dronabinol and acetazolamide under fasted conditions as well as IHL-42X under fed conditions. Blood samples will be collected over 48 hours and the concentrations of the APIs and their major metabolites in the samples will be analysed.

The clinical trial will be conducted at CMAX Clinical Research in Adelaide, South Australia and managed by Novotech. The design of the BA/BE trial is consistent with US Food and Drug Administration recommendations and specific advice received by Incannex in its pre-IND with the FDA regarding the development of IHL-42X for treatment of OSA.

The results of the BA/BE trial will form a critical component of a future new drug application, providing the necessary bridge to the reference listed drugs, thereby facilitating the use of historic safety data via the FDA505(b)2 regulatory pathway. Importantly, the BA/BE study will run in parallel to the pivotal phase 2/3 trial that will commence after the Company opens an IND with the FDA.

Incannex chief scientific officer Dr Mark Bleackley stated: “The BA/BE trial is a very important component of the IHL-42X pipeline. Being able to bridge to historic safety data on the reference listed drugs for dronabinol and acetazolamide accelerates the development of the drug product and reduces cost and timelines. Approval of the study by Bellberry HREC for the BA/BE study allows us to move towards patient recruitment and data collection with CMAX and Novotech.”

Benzinga Cannabis Capital Conference

The Benzinga Cannabis Capital Conference, the place where deals get done, is returning to Chicago this Sept 27-28 for its 17th edition. Get your tickets today before prices increase and secure a spot at the epicenter of cannabis investment and branding.

Photo by Africa Studio on Shutterstock

Related News

Psyched: Millions From Institutional Investor And Fed Funding For Research, M&As, Women Veterans And More

Why A National Cannabis Organization Sacked Half Its Staff, CEO Turnovers And More Exec Changes