Apnimed’s oral sleep apnoea therapy AD109 has met the primary endpoint in a Phase III trial, with hopes to file for approval of the drug in early 2026.
In the Phase III SynAIRgy trial (NCT05813275), AD109 (aroxybutynin 2.5mg/atomoxetine 75mg) met the primary endpoint with a 55.6% mean change in apnoea-hypopnea index (AHI) at 26 weeks compared to placebo. The study enrolled 646 patients with obstructive sleep apnoea (OSA) who are intolerant of or currently refuse continuous positive airway pressure (CPAP) therapy.
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There was also evidence of significantly improved oxygenation, and 51.2% of patients treated with the investigative sleep apnoea pill experienced reduced disease severity.
As well as this, 22.3% of patients treated with AD109 achieved complete OSA disease control, defined as less than five AHI events per hour.
AD109 was generally well-tolerated, and the most common adverse events (AEs) remained consistent with earlier studies.
Overall, topline data from SynAIRgy were similar to that observed in the four-week Phase IIb MARIPOSA study (NCT05071612).
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By GlobalDataAD109 is a first-in-class, anti-apneic neuromuscular modulator which targets the root cause of OSA by increasing upper airway muscle tone during sleep. The drug targets 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.
The drug is in another Phase III study, LunAIRo (NCT05811247), for which Apnimed expects topline data in Q3 2025.
Based on data from SynAIRgy and LunAIRo, Apnimed plans to submit a new drug application (NDA) for AD109 to the US Food and Drug Administration (FDA) by early 2026.
Alliance of Sleep Apnea Partners president and CEO Dr Monica Mallampalli said: “Obstructive sleep apnoea 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… the SynAIRgy results offer people hope that an oral therapy is on the horizon that could make it easier for them to manage their obstructive sleep apnoea and reclaim their lives.”
Vast need for new treatment options
Currently, the standard of care (SoC) for OSA is CPAP therapy; however, in milder cases, or when CPAP is not tolerated, intra-oral mandibular advancement devices and lifestyle changes such as weight loss, smoking cessation and alcohol reduction will also be considered.
Mallampalli added: “There is a vast need for new treatment options. We welcome innovations like this, which are long overdue for our patient community.”
Last year, Eli Lilly gained a label expansion from the FDA for the use of subcutaneous Zepbound (tirzepatide) in moderate-to-severe OSA in adults with obesity after it showed efficacy in a Phase III trial. This marked the first and only prescription medication approved for sleep apnoea.
Earlier in 2025, Apnimed started a Phase IIa trial of another oral drug for sleep apnoea, SASS-001.
