Massachusetts-based Apnimed announced positive topline results from its pivotal phase 3 clinical trial evaluating the efficacy and safety of its lead candidate, AD109, in adults living with mild, moderate and severe obstructive sleep apnea (OSA).
The SynAIRgy trial met its primary endpoint: mean change from baseline in the apnea-hypopnea index (AHI) at 26 weeks compared to placebo. The topline results for the primary and multiple secondary endpoints were similar to the results observed in the previous 4-week MARIPOSA phase 2b clinical trial.
In addition to meeting the primary endpoint, AD109 also demonstrated improvements in other secondary and exploratory endpoints, including: meaningful improvements in oxygenation as assessed by hypoxic burden and oxygen desaturation index; 51.2% of participants treated with AD109 showed a reduction in OSA disease severity category; 22.3% of participants treated with AD109 achieved complete OSA disease control.
Obstructive sleep apnea (OSA) is a serious, chronic sleep-related breathing disease in which the upper airway repeatedly collapses during sleep, leading to intermittent oxygen deprivation. 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. The once-daily pill is a first-in-class combination of aroxybutynin, a novel antimuscarinic, and atomoxetine, a selective norepinephrine reuptake inhibitor. Currently, no available pharmacological treatments directly address the underlying neuromuscular dysfunction that is present in OSA.
Apnimed plans to submit a New Drug Application (NDA) for AD109 to the U.S. FDA by early 2026.