On July 23, Apnimed announced positive topline results from LunAIRo, the second phase 3 clinical trial of AD109 (aroxybutynin 2.5mg, atomoxetine 75mg) in adults with obstructive sleep apnea. Apnimed previously announced results from its SynAIRgy trial of AD109 in May.
LunAIRo study results
Apnimed reports that the 12-month LunAIRo study demonstrated clinically meaningful and statistically significant reductions in airway obstruction at 26 weeks. Participants treated with the once-daily oral drug achieved a mean reduction in the apnea-hypopnea index (AHI) of 46.8% from baseline. In contrast, the AHI was reduced by only 6.8% in those who took a placebo.
The reduction in AHI with AD109 remained significant after 51 weeks, and treatment reduced the AHI to less than 5 — indicating “complete disease control” — in about 23% of participants. The study also found that treatment with AD109 was associated with reductions in hypoxic burden and the oxygen desaturation index.
The LunAIRo trial enrolled 660 adult participants from 64 centers in the U.S. Forty-six percent of participants were women.
Based on the results of the two phase 3 trials, Apnimed indicated that it plans to file a new drug application with the U.S. Food and Drug Administration in early 2026.
About obstructive sleep apnea
Obstructive sleep apnea is a prevalent and serious sleep disorder involving repeated blockage of the airway during sleep, leading to paused breathing and oxygen deprivation. Commonly caused by the collapse of throat tissues, it can result in loud snoring, choking noises, and frequent awakenings, potentially contributing to health problems such as high blood pressure, heart disease, stroke, diabetes and depression.
Sleep apnea can be treated with options such as CPAP therapy, oral appliance therapy, surgery, upper airway stimulation, weight management, positional therapy, and lifestyle changes. In addition, the FDA has approved one prescription medication, Zepbound (tirzepatide), for adults with moderate to severe obstructive sleep apnea and obesity.
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