The first patient has been dosed in a Phase 2 clinical trial evaluating AD109 as a treatment for mild to moderate obstructive sleep apnea (OSA), a once-daily, oral medication that addresses its developers designed to treat the underlying biology of the sleep disorder.
“In the fourth quarter of 2020, we initiated a Phase 2 study with our lead product candidate, AD109, in patients with a broad spectrum of OSA—from mild to severe,” says Larry Miller, MD, Apnimed CEO, in a release. “We believe patients with OSA need a safe, effective, and easy to use disease-modifying treatment. With this study we will explore the safety and effectiveness of several doses of AD109 in patients with milder disease, potentially expanding the population of patients we can help. We anticipate data from both of these Phase 2 studies in the second quarter and plan to move forward with a Phase 3 registrational study later in 2021.”
AD109 combines a selective norepinephrine reuptake inhibitor (atomoxetine) with a novel new chemical entity—a selective antimuscarinic (aroxybutynin). Proof-of-concept for the AD109 program was demonstrated by Apnimed in a Phase 2, parallel group dose-finding study of the combination of atomoxetine and racemic oxybutynin. That study provided evidence of safety and efficacy in the treatment of OSA with a norepinephrine reuptake inhibitor (NRI) + antimuscarinic combination in 140 patients, indicating that a pharmacologic approach could treat the underlying neurobiology of OSA. Aroxybutynin has been shown to be safe and well-tolerated and had a favorable pharmacokinetic profile in a Phase 1 study, paving the way for Phase 2 studies of AD109.
This Phase 2 study is a randomized, double-blind, placebo-controlled, three-period, single-dose crossover factorial study in patients with mild to moderate OSA. A total of 30 participants will be enrolled. Each participant will receive two different dose levels of AD109, and placebo, at bedtime across three overnight periods.