Incannex Healthcare Ltd (ASX:IHL, NASDAQ:IXHL) has initiated a BA/BE study and is targeting submission of an IND application with the FDA in Q1 2023.
The clinical-stage pharmaceutical company is developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs.
Its BA/BE study 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.
IHL-42X is a synergistic composition of dronabinol, a synthetic form of Tetrahydrocannabinol (THC), and acetazolamide, a Carbonic anhydrase inhibitor.
Results from a Phase 2 proof of concept clinical trial undertaken by Incannex were published in 2022, which observed that IHL-42X reduced average apnoea hypopnea index (AHI) by an average of 50.7% versus baseline assessments and 25% of participants experienced greater than an 80% reduction in AHI measure.
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.
Incannex has filed a patent application over IHL-42X, which has been deemed “novel and inventive” by the international patent examiner.
About the current study
The BA/BE study will include 116 participants who will 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 study will be conducted at CMAX Clinical Research in Adelaide, South Australia and managed by Novotech. The design of the BA/BE study is consistent with FDA recommendations for BA/BE and specific advice received by Incannex in the pre-IND meeting.
Results will form a critical component of a future new drug application (NDA), providing the necessary bridge to the reference listed drugs, thereby facilitating the use of historic safety data via the FDA505(b)2 regulatory pathway.
Along with this study, Incannex is preparing an IND application for submission to the FDA, detailing the safety, efficacy and quality of the IHL-42X drug product for the treatment of OSA. This will be a precursor to conducting clinical trials at treatment sites in the United States.
Once the IND is opened, it is continuously updated with research and development results for the purpose of ongoing assessment by the FDA.
Incannex hopes to submit the IND application in Q1 2023 and will then start pivotal, multi-site, Phase 2/3 clinical trials investigating the effects of IHL-42X in patients with OSA.
The trials will assess the safety and efficacy of IHL-42X at the best-performing two doses from the proof-of-concept clinical trial, in patients with OSA over a 12-month treatment period.
Participants will receive one of 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, overnight polysomnography will be conducted to determine the effect of treatment on the patients’ AHI. All drug treatments will be compared to placebo.
Incannex 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.
This study involved contacting 195 sites across 14 countries in North American, Europe, South America, and Australasia. Sixty-three sites expressed interest in conducting the study.
Incannex expects 20-30 sites will eventually be selected to conduct the clinical trials.