Apnimed, a renowned clinical-stage pharmaceutical firm focused on developing oral medicines for the treatment of OSA (Obstructive Sleep Apnea) and related disorders, has reportedly announced that the first patient has been medicated in Phase 2 clinical stage trial assessing AD109, the firm’s innovative, oral, first-in-class pharmaceutical candidate that is being developed for the treatment of obstructive sleep apnea.

If proven to be effective, this pharmacologic approach might significantly change the treatment standard for OSA patients.

Larry Miller, M.D., CEO, Apnimed, stated that the data from this study is expected in the first quarter of 2021 and the firm is planning to move ahead into a Phase III registrational study in 2021. Evidence from the company’s previous proof-of-concept trials have showcased the potential of its oral treatment as a viable option for treating OSA

AD109 integrates a selective NRI (norepinephrine reuptake inhibitor) namely atomoxetine with a new NCE, a selective antimuscarinic. The AD109 program proof of concept was showcased by Apnimed in Phase 2, parallel group dose-searching study of the combination of racemic oxybutynin and atomoxetine. 

The particular study provided proof of efficacy and safety for OSA treatment with a combination of antimuscarinic and NRI in about 140 patients, further hinting that a pharmacologic approach might be suitable for treating the underlying pathophysiology of OSA.

In the trial, AD109 proved to be well tolerated and safe, with no adverse event related to a drug. It further had a promising PK (pharmacokinetic) profile of aroxybutynin, making way for this novel Phase 2 study.

About Apnimed:

Apnimed is a renowned clinical-stage pharma company dedicated to transform the treatment of sleep-apnea built on a simple idea, patients diagnosed with OSA will greatly benefit from an effective and safe oral medicine. Located in Cambridge, Mass., the firm is developing a portfolio of new pharmacologic therapies mainly for sleep apnea and other disorders.

Source credit: https://finance.yahoo.com/news/apnimed-announces-first-patient-dosed-123000903.html