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Incannex Healthcare Announces Positive Topline Results from Pharmacokinetics (PK) Study of IHL-42X, an Oral Combination Medicine for the Treatment of Obstructive Sleep Apnea
Demonstrated bioavailability of IHL-42X, Incannex’s proprietary combination formulation, confirming delivery of both dronabinol and acetazolamideAchieved
About this update from Incannex Healthcare Inc.
[{"type":"text","content":"Demonstrated bioavailability of IHL-42X, Incannex’s proprietary combination formulation, confirming delivery of both dronabinol and acetazolamideAchieved similar PK and equivalent total drug exposure levels of IHL-42X and the reference listed drugs (RLD) for dronabinol and acetazolamide, building a scientific bridge to established safety and toxicology data with the potential to support a future FDA 505(b)(2) new drug application (NDA)Pharmacokinetic results for IHL-42X will inform analysis of anticipated Phase 2/3 data assessing IHL-42X in patients with obstructive sleep apneaContinued excellent safety and tolerability findings, with no serious adverse events reported NEW YORK and MELBOURNE, Australia, Jan. 23, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (Incannex), a clinical-stage biopharmaceutical company leading the way in developing combination medicines, today announced positive topline results from a completed pharmacokinetics (PK) and safety study of IHL-42X, a novel, oral fixed-dose combination of acetazolamide and dronabinol for the treatment of Obstructive Sleep Apnea (OSA). “The topline IHL-42X PK findings we are reporting today provide data necessary to support a 505(b)(2) application in accordance with FDA guidance, assuming continued positive results from our Phase 2 and 3 clinical trials,” said Mark Bleackley, Ph.D., Incannex’s Chief Scientific Officer. “The trial results are consistent with our expectations and the objectives for IHL-42X, a novel, oral fixed-dose combination therapeutic.” The study confirmed bioavailability of IHL-42X, demonstrating delivery of both dronabinol and acetazolamide. The PK profile of IHL-42X was similar to those observed for the respective RLDs, including equivalent total exposure levels observed for the drug molecules. Furthermore, administration of IHL-42X with food, in contrast to fasted conditions, indicated no substantial food effect on overall exposure to acetazolamide. Consistent with what is known for the RLD, an increase in overall exposure to THC was observed when IHL-42X was administered with food compared to fasted state. No serious adverse events were reported during the study. All but one Treatment-Emergent Adverse Event (TEAE) was reported to be mild or moderate. The proportion of subjects reporting at least one TEAE on the IHL-42X fasted period...