Apnimed says sleep apnea drug meets primary endpoint in Phase 3 trial

Apnimed announced positive topline results from its second pivotal Phase 3 clinical trial of Apnimed’s lead candidate AD109. LunAIRo was a 12-month study that evaluated the efficacy and safety of AD109 in adults with mild, moderate and severe OSA, across a wide range of weight classes, with the primary endpoint determined at 26 weeks. The LunAIRo trial met its primary endpoint, demonstrating clinically meaningful and statistically significant reductions in airway obstruction at 26 weeks. Participants treated with AD109 achieved a mean reduction in AHI of 46.8% from baseline at week 26. The reduction in AHI remained significant at end of study. AD109 was generally well-tolerated, with the most common treatment-emergent adverse events being mild or moderate in severity, and consistent with prior studies. No serious adverse events related to AD109 were reported in the LunAIRo trial. The LunAIRo topline results align with the positive topline results previously reported from Apnimed’s SynAIRgy Phase 3 clinical trial, which the Company believes support the safety and efficacy of AD109 in treating adults with mild, moderate and severe OSA, subject to review by FDA. AD109 is designed to be the first pharmacological treatment to improve oxygenation during sleep by directly addressing the neuromuscular root cause of upper airway collapse in people with obstructive sleep apnea. Publicly traded companies that make sleep apnea treatments include Resmed (RMD) and Inspire Medical (INSP).