Incannex Healthcare Inc.

Incannex Healthcare Inc. is a clinical-stage biopharmaceutical company focused on developing medicines for patients with serious chronic diseases and significant unmet needs. The company's primary drug candidate, IHL-42X, is in a pivotal Phase 2/3 clinical trial for obstructive sleep apnea (OSA). IHL-42X is an oral fixed-dose combination of dronabinol and acetazolamide, designed to target two physiological pathways associated with OSA. In a proof-of-concept study in Australia and the Phase 2 portion of the RePOSA clinical trial, IHL-42X reduced the apnea hypopnea index (AHI) and was well-tolerated. In the Phase 2 RePOSA trial, maximum AHI reductions were up to 83% for the high-dose group and up to 79% for the low-dose group. Specifically, 33.3% of patients in the low-dose group and 41.2% in the high-dose group achieved over a 30% AHI reduction, while 13.9% (low-dose) and 14.7% (high-dose) saw reductions exceeding 50%. Both low-dose and high-dose IHL-42X groups achieved a statistically significant reduction in percent change in AHI from baseline compared to placebo (p<0.05). The company is finalizing arrangements for an End of Phase meeting with the U.S. Food and Drug Administration (FDA) to discuss a planned pivotal Phase 3 trial design. Another drug candidate, PSX-001, is in Phase 2 clinical development as an oral synthetic psilocybin treatment combined with psychological therapy for moderate-to-severe generalized anxiety disorder (GAD). A completed Phase 2 clinical trial, PsiGAD1, showed that this combination significantly reduced anxiety scores and was well-tolerated in GAD patients.