Apnimed, Inc. has announced the early completion of enrollment in its SynAIRgy Phase 3 Study, evaluating AD109 (aroxybutynin/atomoxetine) for the treatment of obstructive sleep apnea (OSA). This milestone marks the completion of patient enrollment for all Phase 3 studies of AD109, encompassing over 1,300 participants. Topline data from the SynAIRgy and LunAIRo Phase 3 studies are anticipated in mid-2025. AD109 represents a potential first-in-class oral therapy designed to address the neuromuscular dysfunction associated with OSA.
SynAIRgy Study Details
The SynAIRgy Study (NCT05813275) is a randomized, double-blind, placebo-controlled trial involving 646 participants with OSA who are intolerant to or refuse continuous positive airway pressure (CPAP) therapy. Participants were randomized 1:1 to receive either AD109 or placebo nightly for six months. The primary endpoint is the reduction in airway obstructions, measured by the Apnea-Hypopnea Index (AHI4). A key secondary endpoint assesses the impact of AD109 on OSA symptoms using the PROMIS-Fatigue scale. The study was conducted across 73 centers in the U.S. and Canada.
AD109: A Novel Approach to OSA Treatment
AD109 is a fixed-dose combination of aroxybutynin, a novel antimuscarinic, and atomoxetine, a selective noradrenaline reuptake inhibitor (NRI). This combination targets the neuromuscular cause of upper airway collapse in OSA patients. By addressing this underlying dysfunction, AD109 aims to improve oxygenation during sleep. The drug is administered as a once-nightly oral pill, potentially offering a simpler treatment option compared to existing therapies.
The Need for New OSA Treatments
OSA is a prevalent condition, affecting over 54 million people in the United States and nearly one billion worldwide. The disease is characterized by recurrent upper airway collapse during sleep, leading to intermittent oxygen deprivation. OSA is caused by both neuromuscular dysfunction and anatomical abnormalities. Untreated OSA can lead to serious comorbidities, including hypertension, diabetes, cardiovascular disease, and stroke. Despite available treatments, a significant proportion of individuals with OSA either refuse, abandon, or underutilize them, highlighting the need for additional therapeutic options.
According to Patrick Strollo, Jr, MD, Chairman of the SynAIRgy clinical study, the strong interest in the study reflects the sleep community's desire for new treatment options. Larry Miller, CEO of Apnimed, expressed gratitude to the patients participating in the Phase 3 studies, emphasizing AD109's potential to redefine the standard of care for OSA.
