Incannex announces results from PK study of IHL-42X

Incannex (IXHL) Healthcare 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 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 was reported to be mild or moderate. The proportion of subjects reporting at least one TEAE on the IHL-42X fasted period was similar to the dronabinol fasted period. Fewer subjects reported TEAEs during the acetazolamide fasted treatment period. Food did not have a substantial effect on the number of subjects reporting TEAEs for IHL-42X, with 57.4% fasted vs 58.8% fed.