Apnimed announced that the first patient has been dosed in a Phase 2 clinical trial evaluating AD109, the company’s first-in-class, oral pharmaceutical  under development for the treatment of OSA.

If successful, this pharmacologic approach could substantially change the treatment paradigm for OSA patients.

“There is a clear unmet need for an approach that addresses the underlying cause of OSA,” said Larry Miller, M.D., Chief Executive Officer of Apnimed. “Evidence from earlier proof-of-concept studies demonstrated the potential of our oral therapy as an option for the treatment of OSA. We anticipate data from this Phase 2 study in the first half of 2021 and plan to move forward into a Phase 3 registrational study 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 pathophysiology of OSA. AD109 was safe and well tolerated, with no drug-related adverse events, and had a favorable pharmacokinetic (PK) profile of aroxybutynin, paving the way for this new Phase 2 study.