Summary: Apnimed’s phase 3 SynAIRgy trial found that its investigational oral drug AD109 significantly reduced AHI and improved oxygenation in adults with OSA across all severity levels, supporting plans for a 2026 FDA submission.
Key Takeaways:
- AD109 met the primary endpoint, mean change in AHI at 26 weeks, across a broad range of people with mild, moderate, and severe OSA.
- Study participants treated with AD109 achieved a mean reduction in AHI of 55.6% from baseline and achieved significantly improved oxygenation and reduced disease severity.
- AD109 is a first-in-class, anti-apneic neuromuscular modulator that increases upper airway muscle tone during sleep.
- Apnimed expects topline results in Q3’25 from its second phase 3 clinical trial, LunAIRo, and plans to submit a new drug application to the FDA for AD109 by early 2026.
Positive topline results from Apnimed Inc’s pivotal phase 3 SynAIRgy clinical trial evaluating the efficacy and safety of Apnimed’s lead candidate AD109 (aroxybutynin 2.5mg/atomoxetine 75mg) were released today.
The SynAIRgy trial in adults living with mild, moderate, and severe OSA, and across all weight classes, met its primary endpoint: mean change from baseline in the apnea-hypopnea index (AHI) at 26 weeks compared to placebo (p=0.001). 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. 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.
AD109 is designed to target the neurobiology of the hypoglossal motor nucleus by increasing signals to the upper airway muscles during sleep, leading to the reduction or prevention of upper airway collapse.
“Today is a landmark moment for Apnimed and for millions living with OSA who have long struggled with limited treatment options,” says Larry Miller, MD, CEO of Apnimed, in a release. “The positive results from our phase 3 SynAIRgy trial bring us closer to realizing our vision of offering a simple, safe, and effective oral drug—one that is grounded in science, driven by unmet need, and centered on people with OSA. We believe these results represent the dawn of a new era in the OSA treatment paradigm. We are deeply grateful to the patients, investigators, and clinical teams whose partnership and commitment made this achievement possible. Importantly, these results increase our confidence in the expected outcome of the second phase 3 clinical trial, LunAIRo, with topline results expected in Q3’25.”
Additional Efficacy Results
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 (p<0.0001) and oxygen desaturation index (p=0.001)
- 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 (defined as AHI <5 events/hour)
“These phase 3 topline results are highly encouraging and represent the potential for a much-needed innovation in the treatment of OSA,” says Patrick Strollo, Jr., MD, study chair of the SynAIRgy clinical trial and vice chair of Medicine for Veteran’s Affairs at the University of Pittsburgh School of Medicine, in a release. “For too long, progress in OSA has been limited, leaving many people with OSA without sustainable treatment options. The results from SynAIRgy suggest that if approved, AD109 could offer a compelling new treatment option—a novel oral drug that targets the neuromuscular root cause of airway obstruction in sleep apnea and holds promise for transforming care for a broad range of patients.”
“OSA should be considered a top public health priority: it is a serious, common, chronic disease that affects a wide range of people, impacting both males and females of all age groups, ethnicities, and weight classes, including those with or without obesity,” says Monica Mallampalli, PhD, president and CEO of the Alliance of Sleep Apnea Partners, in a release. “There is a vast need for new treatment options. We welcome innovations like this, which are long overdue for our patient community. The SynAIRgy results offer people hope that an oral therapy is on the horizon that could make it easier for them to manage their OSA and reclaim their lives.”
Apnimed plans to submit a new drug application for AD109 to the US Food and Drug Administration by early 2026 for regulatory review. The full data for SynAIRgy will be presented at a medical congress later this year and published in a peer-reviewed scientific journal. Apnimed also anticipates the availability of topline data in Q3 2025 from the second Phase 3 LunAIRo trial, a one-year study of AD109 in adults with OSA.
We Recommend for You:
ID 10569792 © Iakov Kalinin | Dreamstime.com
