Apnimed Reveals Positive Phase 3 Trial Results for AD109

Apnimed, Inc., a pharmaceutical company based in Cambridge, Massachusetts, has announced promising results from its pivotal Phase 3 SynAIRgy clinical trial, evaluating the effectiveness and safety of its lead candidate, AD109, in adults with obstructive sleep apnea (OSA). This condition affects nearly 80 million individuals in the United States and about one billion worldwide. The trial focused on adults with mild, moderate, and severe OSA, across all weight classes, and successfully met its primary endpoint of reducing the apnea-hypopnea index (AHI) at 26 weeks compared to a placebo.

AD109, a first-in-class anti-apneic neuromuscular modulator, is designed to tackle the root cause of OSA by enhancing upper airway muscle tone during sleep. In the study, participants who received AD109 experienced an average reduction in AHI of 55.6% from baseline and showed significantly improved oxygenation and reduced disease severity. Additionally, 51.2% of the treated participants observed a reduction in the severity category of their OSA, and 22.3% achieved complete OSA disease control.

The SynAIRgy trial is notable for being the largest Phase 3 clinical trial of a medication to treat OSA, enrolling 646 adult participants across 73 centers in the United States and Canada. The trial's participants reflected the diverse demographic composition typically seen in sleep clinic populations, including nearly half female participants, multiple racial groups, and a range of weight classes from healthy weight to obese. Participants also spanned all levels of OSA severity—mild, moderate, and severe.

AD109's promising results are significant given the large population affected by OSA and the limited treatment options currently available. Conventional treatments often involve continuous positive airway pressure (CPAP) devices or invasive surgeries, which many patients find difficult to tolerate or use consistently. AD109, however, offers a simpler, once-daily oral medication alternative that directly targets the neuromuscular dysfunction causing airway collapse in OSA, potentially transforming treatment for a wide range of patients.

Apnimed’s CEO, Dr. Larry Miller, expressed optimism about these results, highlighting the potential of AD109 to become a revolutionary treatment option for OSA. The company plans to submit a New Drug Application (NDA) for AD109 to the U.S. Food and Drug Administration by early 2026. Furthermore, Apnimed expects to release topline results from its second Phase 3 trial, LunAIRo, in the third quarter of 2025. This trial is a one-year study assessing AD109's efficacy in adults with OSA.

The SynAIRgy trial's success signifies a potential breakthrough in OSA treatment, as noted by Dr. Patrick Strollo, Jr., the study chair and Vice Chair of Medicine for Veterans Affairs at the University of Pittsburgh School of Medicine. He emphasized the trial's promising results as a much-needed innovation for those struggling with limited OSA treatment options.

Monica Mallampalli, President and CEO of the Alliance of Sleep Apnea Partners, highlighted the significance of the SynAIRgy results, underscoring the urgent need for new treatment options in OSA management. The introduction of an effective oral therapy could ease the management of OSA for many patients, offering hope for improved quality of life.

With AD109 advancing through clinical trials and the promising results from SynAIRgy, Apnimed aims to redefine the treatment landscape for sleep-related breathing disorders, offering simpler, more accessible solutions for those affected by OSA.