Incannex Healthcare Inc. provided the following update on its proprietary IHL-42X drug candidate. Obstructive sleep apnea (OSA) is characterised by a narrowing or obstruction of the upper airway during sleep, which interrupts breathing resulting in decreased oxygen uptake and poor sleep quality. Results from IHL-42X proof-of-concept Phase 2 clinical trial: To demonstrate proof-of-concept for IHL-42X in the treatment of OSA, Incannex conducted a phase 2 clinical trial compared three dose strengths of IHL-42X, low dose (2.5 mg dronabinol + 125 mg acetazolamide), medium dose (5mg dronabinol + 250 mg acetazolamide) and high dose (10 mg dronabinol + 500 mg acetazolamide), to placebo with regarding safety and efficacy in OSA patients.

The trial was a four-period cross over study whereby every patient received each dose of IHL-42X and placebo for 7 days. The seven-day treatment periods were separated by 7-day washout periods to minimize any lasting effect of the treatment. On night seven of each treatment period, patients completed an overnight sleep study with polysomnography (PSG) to assess AHI and other sleep parameters.

The results of the sleep studies were compared to baseline values, captured prior to the start of treatment. Change in AHI relative to baseline was the primary endpoint for the study. The results of the proof-of-concept study confirmed the hypothesis that the combination of dronabinol and acetazolamide is effective at treating OSA.

The average reduction in AHI compared to baseline for all three doses of IHL-42X. The difference for all three doses compared to placebo was statistically significant (p The RePOSA study, a Phase 2/3 clinical trial investigating the safety and efficacy of IHL-42X in patients with obstructive sleep apnea. To further assess the safety and efficacy of I HL-42X in patients with OSA, Incannex is conducting a Phase 2/3 clinical study that will be conducted at fifty-five sites across the United States, Europe and other countries.

The study has been named RePOSA, from Revealing the Efficacy of IHL-42X use in Patients with OSA. The drug products being tested in the RePOSA study are representative of the to-be-marketed formulation developed by Incannex. In preparation for the study, Incannex conducted a pre-Investigational New Drug (IND) meeting with the US FDA to obtain feedback on the proposed clinical development strategy, safety and rationale for the IHL-42X drug product.

This feedback was incorporated into the RePOSA Phase 2/3 study design and corresponding IND application. The IND was cleared by the FDA, and study may proceed notification was received in August 2023. The RePOSA study consists of two component studies.

This announcement has been approved for release by the Incannex Board of Directors.