(RTTNews) - Incannex Healthcare (IXHL), a clinical-stage biopharmaceutical company, on Thursday announced positive topline results from its pharmacokinetics or PK study of IHL-42X, a novel oral combination therapy for the treatment of Obstructive Sleep Apnea or OSA.
The study confirmed the bioavailability of IHL-42X, which combines dronabinol and acetazolamide, demonstrating comparable PK profiles to the reference-listed drugs or RLDs.
Notably, the total drug exposure levels for both components of IHL-42X were found to be equivalent to those of the individual RLDs.
The study also showed that food intake had no significant effect on acetazolamide exposure, though THC exposure was slightly higher when the drug was administered with food.
With continued positive results from its ongoing Phase 2/3 RePOSA trial, the company plans to leverage these findings to support a future FDA 505(b)(2) New Drug Application or NDA for IHL-42X.
Safety data from the study were also encouraging, with no serious adverse events reported and most treatment-emergent adverse events or TEAEs being mild or moderate in severity.
The PK results, along with favorable safety data, provide a strong foundation for advancing the development of IHL-42X as a potential new treatment for OSA.
The global Phase 2/3 RePOSA trial is evaluating IHL-42X in patients with OSA who are non-compliant, intolerant, or naïve to positive airway pressure devices, including CPAP.
The company expects topline data from the U.S. Phase 2 portion in the first half of 2025.
IXHL closed Wednesday's (Jan.22 2025) trading at $1.88 down 1.29%. In premarket trading Thursday, the stock is down over 7% at $1.70.
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