Apnimed Inc.’s lead oral therapy for obstructive sleep apnea has delivered a second round of positive phase III data, bringing a potential U.S. FDA filing closer. Top-line results taken from the second pivotal late-stage study show AD-109 (aroxybutynin 2.5mg/atomoxetine 75 mg) hit its primary endpoint with clinically meaningful and statistically significant drops in airway obstruction at 26 weeks.

Mirroring results reported in a phase IIb study, Apnimed Inc.’s first of two pivotal trials testing AD-109 as an oral therapy in obstructive sleep apnea hit primary and secondary endpoints. Should similar findings emerge from a second phase III trial, expected to read out in a couple of months, the privately held firm anticipates a U.S. NDA filing in early 2026.

Apnimed Inc. is gearing up to start phase III testing with AD-109, a once-daily combination of atomoxetine and aroxybutynin that has the potential to be the first oral therapy to treat obstructive sleep apnea, following positive results from the phase IIb Mariposa trial.

It’s a first for Larry Miller. In his 30 years of working in pharma, he has never run a company that didn’t have a pack of near competitors scrambling to develop a therapy. “Not even close,” he told BioWorld. Miller, the CEO of Apnimed Inc., just saw the company close on a $25 million series B to help drive its lead program, a once-daily, oral obstructive sleep apnea (OSA) therapy, into a phase III registrational trial.