Incannex Healthcare commits to a 116-person bioavailability/ bioequivalence (BA/BE) study and will submit an investigational new drug application to FDA.

Incannex Healthcare (ASX:IHL) will assess the pharmacokinetics and tolerability of the two key active pharmaceutical ingredients (APIs) in IHL-42X compared to their respective US Food and Drug Administration (FDA) reference listed drugs.

Incannex hopes to achieve the first ever registered pharmaceutical product on the market for sleep apnoea.  It hopes to displace the current treatment standard, which is the mechanical CPAP device that has a considerable market size of US$10B per annum – but is associated with poor patient compliance due to discomfort.

The BA/BE study being undertaken in South Australia will, amongst other things, look at the effect of food on the pharmacokinetics of IHL-42X and include 116 participants who will each complete multiple treatment periods.

Study results to form critical component of NDA

The design of the BA/BE study is consistent with FDA recommendations and specific advice received by IHL in its pre-IND meeting with the FDA. Subject to ongoing clinical success, the results from the study will form a critical component of a future new drug application by providing a necessary bridge to IHL-42X’s reference listed drugs, thereby facilitating the use of certain historical data.

IHL prepares for Phase 2/3 trials for OSA

The cannabinoid and psychedelics pharmaceutical company also stated that it is targeting submission of an Investigation New Drug (IND) application with the US Food and Drug Administration (FDA) in Q1 2023.

An IND application is a comprehensive information document detailing safety, efficacy, and quality of IHL-42X and is needed before holding clinical trials at treatment sites in the US.

Once opened, the IND it is continuously updated with research and development results for the purpose of ongoing assessment by the FDA.

IHL aims to submit the IND application in Q1 2023, followed by commencement of pivotal, multi-site, Phase 2/3 clinical trials..

Feasibility Studies for multiple trial sites – completed

In preparation for the Phase 2/3 clinical trials, IHL has undertaken a 12-week feasibility study whereby the trial design was provided to potential investigators along with a survey to gauge interest in conducting the study and identify any region-specific regulatory hurdles.

The feasibility study involved contacting 195 trial sites across 14 countries in North America, Europe, South America, and Australasia. 63 sites expressed interest in conducting the study. IHL anticipates that 20-30 sites will eventually be selected to conduct the clinical trials.

Meanwhile, IHL has completed a Phase 1 clinical trial measuring the safety, tolerability, and pharmacokinetic profiles of its anti-inflammatory IHL-675A. IHL is arranging Phase 2 studies for patients with rheumatoid arthritis, inflammatory bowel disease and lung inflammation.

Incannex is also considerably advanced in a phase 2 clinical trial looking at the use of psilocybin in patients with generalised anxiety disorder. The psychedelic trial is the only of its type in the world and is being done in partnership with Monash University.

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.