– Data from this study anticipated in first half of 2021 –
– AD109 is a disease-modifying therapeutic for the treatment of Obstructive Sleep Apnea –
–1-month open label extension study to be conducted following double-blind placebo-controlled study to demonstrate durability of effect –
CAMBRIDGE, Mass. November 24, 2020 – 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 first 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 registration 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.
About the study
The Phase 2 study is a randomized, double-blind, placebo-controlled, 4-period, single-dose crossover factorial study in patients with OSA. This factorial study is designed to demonstrate that both atomoxetine and aroxybutynin contribute to the efficacy of AD109 in OSA. A total of 48 participants will be enrolled. At bedtime during 4 overnight periods, each participant will receive a single dose of AD109, the individual components that make up AD109 (aroxybutynin and atomoxetine), and placebo.
The primary endpoint of the study is change in the apnea-hypopnea index (AHI), an index used to indicate the severity of sleep apnea, following treatment with AD109 as compared to the other three study treatments. Apnimed will also conduct a 4-week open-label extension designed to confirm and extend safety and efficacy findings from the first portion of the study.
More information can be found at clinicaltrials.gov under the study ID number NCT04580394.
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 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, hypertension, diabetes, cardiovascular disease, strokes, and 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 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 pill 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.