Apnimed backs OSA pill with two new peer-reviewed articles

CAMBRIDGE, Mass. – Apnimed has published two peer-reviewed articles on AD109 (aroxybutynin 2.5 mg/atomoxetine 75 mg), an investigational, once-daily oral pill taken at bedtime designed to improve oxygenation and target the neuromuscular root cause of obstructive sleep apnea (OSA). The Phase 3 SynAIRgy trial results are published in the American Journal of Respiratory and Critical Care Medicine (AJRCCM), alongside a companion mechanistic review article in the American Journal of Respiratory Cell and Molecular Biology (AJRCMB), that highlights AD109's neuromuscular mechanism of action and the biological rationale that directly informed the design and success of the Phase 3 program, the company says. "The publication of the SynAIRgy Phase 3 results, together with a companion review article on the underlying biology, provides important insights into OSA as a treatable, multifactorial disease," said Patrick J. Strollo, Jr., M.D., study chair of the SynAIRgy clinical trial and vice chair of medicine for Veterans Affairs at the University of Pittsburgh School of Medicine. "These data support neuromuscular dysfunction as a key driver of disease and demonstrate that targeting this pathway can lead to meaningful improvements in objective physiologic measures, including airway obstruction and oxygenation." Results from the SynAIRgy trial as published in AJRCCM (on treatment estimand):

• 55.6% reduction in apnea-hypopnea index (AHI) (≥ 4% desaturation criterion for hypopneas) from baseline to week 26 (p≤0.0001 vs. placebo)
• 60.5% reduction in geometric mean in hypoxic burden (p<0.0001 vs. placebo) from baseline to week 26
• Mean reduction of 6.5 events/hr in oxygen desaturation index (p<0.0001 vs. placebo) from baseline to week 26
• 39.6% of participants had AHI reductions ≥ 50% (p<0.0001 vs. placebo)
• 22.3% of participants achieved disease control (AHI <5 events/hour)
• Observed across participants with mild, moderate, and severe OSA
• Consistent in participants with and without obesity
• Improvements observed as early as week four and maintained through week 26

AD109 has received Fast Track designation from the Food and Drug Administration (FDA) for the treatment of OSA. Apnimed has submitted its NDA for AD109 to the FDA, and based on FDA's prior feedback, Apnimed expects a potential Prescription Drug User Fee Act (PDUFA) target action date in the first quarter of 2027, subject to FDA acceptance of the NDA for review.

• Related: Apnimed secures $150M in debt financing ahead of planned launch of pill to treat OSA.