Apnimed announced its oral candidate AD109 achieved primary endpoints in the Phase III LunAIRo trial for obstructive sleep apnoea (OSA), showing 46.8% reduction in apnoea-hypopnoea index (AHI) versus 6.8% for placebo at week 26 (p<0.001). The nightly dosed combination of atomoxetine and aroxybutynin maintained efficacy through week 51 with no serious adverse events, replicating positive results from the earlier SynAIRgy trial. AD109 targets upper airway muscles to prevent collapse during sleep, offering a potential alternative to cumbersome CPAP devices for OSA's 1 billion global sufferers.

The company plans a 2026 submission in its US homeland for AD109, which could become the first pharmacologic OSA treatment. Current therapies like continuous positive airway pressure (CPAP) face low adherence due to discomfort. AD109's neuromuscular mechanism and convenience may address this gap, with mild-to-moderate side effects consistent across trials. Apnimed's data suggests the drug benefits mild, moderate and severe OSA patients.

According to PharmCube's NextBiopharm® database, Apnimed boasts the largest OSA pipeline globally, followed by Eli Lilly. Click here to request a free trial for NextBiopharm®.

Source:
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