AD109 obstructive sleep apnea treatment ushered in a major breakthrough: Phase 3 clinical trial achieved positive results

2025 May AD109, an oral drug candidate for patients with pan>OSA, achieved positive top-line results in the pivotal Phase 3 clinical trial of SynAIRgy. The study covered patients with mild to severe OSA, covering different weight categories, and verified the efficacy and safety of AD109. Trial data show that after 26 weeks of treatment, AD109 significantly improved the apnea-hypopnea index (AD109 span>AHI), and reached a statistically significant difference (p=0.001), showing good clinical application potential.

Obstructive sleep apnea is a common sleep disorder in which patients' throat muscles relax during sleep, leading to partial or complete obstruction of the airway, which is manifested by repeated awakenings at night, severe snoring, and decreased sleep quality. This disease not only affects the quality of life, but may also cause serious health problems such as high blood pressure and heart disease. Currently, the standard treatment for obstructive sleep apnea is to use a continuous positive airway pressure (CPAP) device to deliver pressurized air to the airway through a mask to prevent airway collapse. However, compliance with CPAP is low, and there are no oral medications that effectively address the neuromuscular dysfunction of this disease.

It is worth noting that Eli Lilly’s weight loss drugZepbound (tisipatide) will be released in202412Month became the first prescription drug approved by FDA to treat obese adultsOSA, but its scope of application is limited. In contrast, AD109 is a potential "first-in-class" anti-obstructive sleep apnea neuromuscular modulator, which is composed of selective demethylation A fixed-dose combination of the epinephrine reuptake inhibitor atomoxetine and the antimuscarinic drug aroxybutynin. This combination is designed to directly improve neuromuscular function of the upper airway during sleep, addressing the root causes of airway collapse, thereby increasing nighttime oxygenation levels.

The SynAIRgy trial was a randomized, double-blind, placebo-controlled study that enrolled 646 patients aged 18 years and older with mild to moderate to severe obstructive sleep apnea who were intolerant or refused CPAP treatment. The subjects were divided into groups according to the ratio of 1:1 and took AD109 or placebo every night before going to bed. The main efficacy indicator is the change from baseline in the apnea-hypopnea index (AHI) detected by polysomnography at 26 weeks. The results showed that the AD109 groupAHI reduced AHI on average by 55.6%, which was significantly better than the placebo group (p=0.001). In addition, oxygenation-related indicators such as hypoxic load and oxygen desaturation index were significantly improved, reaching high statistical significance respectively (p<0.0001 and p=0.001). After treatment, more than half (51.2%) of patients experienced a reduction in disease severity, and approximately 22.3% achieved successOSAFull control (AHIless than 5 times per hour).

In terms of safety, AD109 showed good tolerability, with no serious adverse events related to the drug, and the adverse reactions were consistent with those in early trials.

Dr. Patrick Strollo, deputy medical director for Veterans Affairs at the University of Pittsburgh School of Medicine, said that the results of this phase 3 clinical trial are very meaningful and herald an innovative breakthrough in the treatment of obstructive sleep apnea. AD109As the first oral drug targeting OSA neuromuscular disorders, if approved, it will bring new treatment options to the majority of patients and is expected to completely change the existing treatment landscape.

SynAIRgyDetailed data from the trial will be presented at future medical conferences and published in professional journals. Apnimedplans to ship to the United States at the beginning of 2026FDA submitted a new drug marketing application for AD109, and also submitted another one-year 3LunAIRo trial, which is currently underway, with top-line data expected to be released in the third quarter of2025.

Price information:Apnimed announces positive topline results in the first landmark phase 3 clinical trial of AD109, an investigational once-daily oral pill for obstructive sleep apnea. News release. Apnimed. May 19, 2025.