Incannex Healthcare details large scale pivotal clinical trial program to develop IHL-42X for obstructive sleep apnoea
Incannex will also lodge an IND with the US FDA in the new year so it can undertake multi-site trials of IHL-42X in OSA in the US.
Clinical-stage medicinal cannabis and psychedelic pharmaceutical company Incannex Healthcare (ASX: IHL) has initiated a BA/BE (bioavailability/bioequivalence) clinical trial evaluating IHL-42X in obstructive sleep apnoea (OSA).
Incannex will also open an IND (Investigational New Drug Application) with the US Food and Drug Administration in the new year so that it can conduct multi-site pivotal clinical trials in the US.
There is currently no registered drug on the market for OSA and Incannex plans to be the first to achieve FDA approval for such a drug with IHL-42X.
The global annual market for OSA detection and treatment is large at approximately US$10 billion per annum and comprises low compliance treatment methods such as the mechanical CPAP device and other breathing aides.
The BA/BE trial will be carried out on 116 participants who will each receive dose treatments with IHL-42X, dronabinol, acetazolamide and placebo under fasted conditions, and one dose of IHL-42X under fed conditions.
This study will be conducted at CMAX Clinical Research in South Australia and managed by Novotech, an independent clinical research organisation focused on maintaining proper procedures and data collection.
IND application
Incannex has stated in today’s announcement that it is “well progressed” in drafting the IND application. The IND application is a precursor to the commencement of clinical trials at treatment sites in the US and is expected to be submitted to the FDA early in the new year.
Once the IND is open, Incannex can also start pivotal, multi-site phase 2/3 clinical trials to assess the effects of IHL-42X in patients with OSA over an extended 12-month period.
Phase 2/3 trials will be undertaken using the best performing two doses observed in the phase 2 proof-of-concept trial that was deemed a success by the company in June of this year.
Phase 2 proof of concept clinical success
The apnea-hypopnea index (AHI) is the main diagnostic tool for determining the presence and severity of OSA.
In June of this year, IHL reported that its trial participants experienced a 50.7% reduction in AHI reading versus the patient’s baseline reading. And one quarter of participants experienced greater than an 80% reduction in AHI reading.
No serious side effects were reported in the trial and blood THC levels the morning after treatment were reported to be below the limits for impaired driving.
Furthermore, patients were recorded to have significantly higher blood oxygen levels after treatment.
Pivotal trial sites feasibility studies
In preparation for the pivotal phase 2/3 trials, Incannex has completed a 12-week feasibility study and sent copies of the trial design to potential investigators along with a survey to gauge their interest in conducting the study and identify region-specific regulatory hurdles.
The company contacted 195 sites across 14 countries in North America, Europe, South America, and Australasia.
Incannex said 63 clinical trial sites had expressed an interest in participating but that it only requires 20-30 sites.