On May 19, 2025, Apnimed announced positive topline results from its Phase 3 SynAIRgy clinical trial of AD109 (aroxybutynin 2.5 mg/atomoxetine 75 mg), an investigational once-daily oral pill for adults with mild, moderate and severe obstructive sleep apnea across all weight classes.
About AD109
AD109 is a once-daily pill that aims to improve oxygenation during sleep in people with sleep apnea by targeting the neuromuscular root cause of upper airway collapse. It combines aroxybutynin, a novel antimuscarinic, and atomoxetine, a selective norepinephrine reuptake inhibitor, to increase signaling to the upper airway muscles during sleep by targeting the neurobiology of the hypoglossal motor nucleus.
AD109 met the primary endpoint in the SynAIRgy clinical trial: mean change from baseline in the apnea-hypopnea index (AHI) at 26 weeks compared to placebo. Study participants treated with AD109 achieved a mean reduction in AHI of 55.6% from baseline.
In addition to meeting the primary endpoint, AD109 also demonstrated improvements in oxygenation as assessed by hypoxic burden and oxygen desaturation. Additionally, 51.2% of participants treated with AD109 showed a reduction in sleep apnea disease severity category, while 22.3% of participants achieved completed disease control, defined as an AHI of less than five events per hour.
Apnimed reported that AD109 was generally well-tolerated, and the most common adverse events were consistent with earlier AD109 clinical trials. No serious adverse events related to AD109 were reported in the SynAIRgy trial.
The SynAIRgy trial was a randomized, double blind, placebo-controlled, parallel-arm six-month clinical trial of AD109 in participants with obstructive sleep apnea who are intolerant to or refuse CPAP therapy. It involved 646 adult patients, including 49.1% females, individuals from multiple racial groups, and a range of weight classes, with sleep apnea severity levels distributed as mild (34.4%), moderate (42.4%), and severe (23.2%).
According to the company’s press release, Apnimed expects topline results from its second Phase 3 clinical trial, LunAIRo, in Q3 2025. It plans to submit a New Drug Application for AD109 to the U.S. FDA by early 2026 for regulatory review.
About Obstructive Sleep Apnea
Obstructive sleep apnea is a prevalent and serious sleep disorder involving repeated blockage of the airway during sleep, leading to paused breathing and oxygen deprivation. Commonly caused by the collapse of throat tissues, it can result in loud snoring, choking noises and frequent awakenings, potentially contributing to health problems such as high blood pressure, heart disease, stroke, diabetes and depression.
Sleep apnea can be treated with options such as CPAP therapy, oral appliances, surgery, weight management, positional therapy and lifestyle changes. In addition, the FDA has approved one prescription medication, Zepbound (tirzepatide), for adults with moderate to severe obstructive sleep apnea and obesity.
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