Incannex Pill Cuts Sleep-Apnea Events 83% in Mid-Stage Study

Incannex Healthcare said its experimental pill IHL-42X achieved statistically and clinically significant results in a mid-stage study of obstructive sleep apnea, cutting the Apnoea-Hypopnoea Index (AHI) by as much as 83 percent from baseline in the high-dose group and 79 percent in the low-dose cohort. The randomized, double-blind, placebo-controlled RePOSA Phase 2 trial enrolled 121 adults with moderate-to-severe disease. Between 33.3 percent and 41.2 percent of treated patients recorded reductions of more than 30 percent in AHI, while up to 14.7 percent experienced drops exceeding 50 percent. The candidate also delivered significant improvements in oxygen desaturation, sleep quality and patient-reported fatigue scores. IHL-42X was well tolerated, with no serious adverse events and only infrequent, mostly mild to moderate, treatment-emergent side effects. The safety and efficacy profile positions the drug as a potential first-in-class oral therapy for an estimated 900 million people worldwide who lack pharmaceutical options beyond continuous positive airway pressure devices. The Melbourne- and New York-based company said it is preparing for an End-of-Phase 2 meeting with the US Food and Drug Administration to discuss Phase 3 trial design and a possible accelerated path to registration.