Summary: Incannex Healthcare reported business highlights for the quarter, including positive top-line results from a pharmacokinetics and safety study of IHL-42X for obstructive sleep apnea, progress in the global phase 2/3 RePOSA trial, the establishment of an OSA clinical advisory board, and a decrease in R&D expenses due to trial completions and resource reallocation.
Key Takeaways
- Positive IHL-42X pharmacokinetics findings for the treatment OSA support future FDA 505(b)(2) New Drug Application submission.
- RePOSA clinical trial design includes expansion to both UK and US sites for the phase 3 trial.
- New OSA clinical advisory board announced.
Incannex Healthcare Inc, a clinical-stage biopharmaceutical company developing oral combination medicines, provided business highlights for the quarter that ended December 31, 2024.
“Patients with obstructive sleep apnea need new and convenient therapeutic options to manage this serious, chronic, and life-threatening disease. We are enthusiastic about the potential for IHL-42X, an oral, once-daily treatment that uniquely targets physiological pathways responsible for the airway obstruction characteristic of OSA,” says Joel Latham, Incannex’s president and CEO, in a release. “We achieved a key milestone for our OSA program, reporting positive top-line results from a pharmacokinetics (PK) and safety study of IHL-42X, conducted alongside our global phase 2/3 RePOSA study.”
Incannex Clinical Highlights
- Announced positive top-line results from the completed pharmacokinetics and safety study of IHL-42X, a novel, oral fixed-dose combination of acetazolamide and dronabinol for the treatment of OSA.
- In line with expectations, the study demonstrated bioavailability of IHL-42X, confirming delivery of both drug components. Moreover, the pharmacokinetics profiles of the active ingredients in IHL-42X were similar to those established for the reference listed drugs, and total drug exposure levels from IHL-42X were found to be equivalent to those of the reference listed drugs, building a scientific bridge to the established safety and toxicology data.
- These results have the potential to support a future FDA 505(b)(2) new drug application and will aid in the analysis of the global phase 2/3 RePOSA study.
Operational Highlights
- The RePOSA global phase 2/3 clinical trial is “progressing well,” according to a press release, “with strong recruitment and enrollment at the US sites.” Building on the positive momentum and continued interest in patient recruitment, the trial design includes expansion to both UK and US sites for the phase 3 trial.
- The company has completed manufacturing of the IHL-42X clinical supply needed to initiate phase 3 of the clinical trial.
- Established an IHL-42X OSA clinical advisory board and appointed Alison Wimms, PhD as an advisor, representing ResMed. Wimms brings two decades of sleep medicine industry and research expertise to Incannex’s new OSA advisory board. “The board marks an important step in fostering collaboration as we advance our global phase 2/3 ‘RePOSA’ clinical study in OSA,” according to Incannex.
Financial Highlights
- Research and development expenses for the three months ended December 31, 2024 totaled $1.4 million USD, compared to $2.6 million USD for the same period in 2023. The primary R&D expense for the period was associated with the global phase 2/3 RePOSA clinical trial for OSA, while the primary decrease in expense was due to the completion of the IHL-42X safety and pharmacokinetics clinical trial, in addition to pausing the phase 2 IHL-675A Australia study in rheumatoid arthritis to re-allocate use of resources to a larger US phase 2 IHL-675A clinical study, where an expedited regulatory pathway may be available.
“Looking ahead, we are committed to executing our clinical programs and are energized by the upcoming catalysts, including the top-line readout from the US phase 2 portion of the IHL-42X trial expected in the first half of 2025,” Latham says.
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