Apnimed, a clinical-stage pharmaceutical company focused on developing oral medicines to treat Obstructive Sleep Apnea (OSA) and related disorders, today announced that the first patient has been dosed in a Phase 2 clinical trial evaluating AD109 as a treatment for mild to moderate OSA. If successful, AD109 could offer an entirely new approach to treating OSA with a once-daily, oral medication that addresses the underlying biology of the disease.
“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,” said Larry Miller, M.D., Chief Executive Officer of Apnimed. “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 (NCE) – 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 (PK) profile in a Phase 1 study, paving the way for Phase 2 studies of AD109.