CAMBRIDGE, Mass.--(BUSINESS WIRE)--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.
About the study
The 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.
More information can be found at clinicaltrials.gov under the study ID number NCT04631107.
Apnimed’s lead product candidate, AD109, targets the neurologic control and facilitates the activation of the upper airway dilator muscles to maintain an open airway during sleep. AD109 is a first-in-class, oral pharmaceutical combination dosed once-daily at bedtime, designed to treat OSA patients across a broad spectrum of disease severity. AD109 combines a selective norepinephrine reuptake inhibitor (NRI) with a low dose of our novel NCE selective antimuscarinic. The investigational drug is designed to be safe, effective, and convenient, addressing the key limitations of the current standard of care treatments.
About Obstructive Sleep Apnea
Obstructive Sleep Apnea (OSA) is one of the most common and serious sleep disorders and is estimated to affect more than 25 million Americans, though underdiagnosis continues to be a serious problem. OSA is characterized by partial or complete upper airway closure that occurs during sleep, which often leads to poor sleep, and in the long-term has been shown to exacerbate hypertension, diabetes, cardiovascular disease, strokes, and lead to early mortality. Additionally, OSA can impair work productivity, reduce functional ability, and lower quality of life.
Sleep-related muscular relaxation driven by the central nervous system is the key neurologic issue leading to OSA. In patients with OSA, sleep onset leads to a reduction in neuromuscular control of the upper airway and a corresponding relaxation of the upper airway and tongue muscles. The vast majority of diagnosed patients are prescribed positive air pressure therapy devices such as continuous positive airway pressure, or CPAP, but many patients are dissatisfied with these mechanical nighttime devices and fewer than half are compliant long-term, leaving a significant population untreated, undertreated and at risk.
Apnimed is a clinical-stage pharmaceutical company working to transform the treatment of sleep apnea based on a simple idea – patients with Obstructive Sleep Apnea will benefit from treatment with a safe and effective oral medication. Apnimed’s lead development program targets the neurologic control of upper airway muscles to maintain an open airway during sleep. The drug is delivered as a convenient once-daily at bedtime. Based in Cambridge, Mass., the company is developing a portfolio of novel pharmacologic therapies for sleep apnea and related disorders. Learn more at apnimed.com.