Apnimed Announces First Patient Dosed in SynAIRgy, the Second Phase 3 Clinical Study of AD109, a Potential Nighttime Oral Treatment for Obstructive Sleep Apnea

-- SynAIRgy Compares AD109 to Placebo Over 6 Months in People with OSA who Are Intolerant of or Refuse Positive Airway Pressure (PAP) Therapy, the Current Standard of Care

-- Part of a two-study registrational Phase 3 program that also includes LunAIRo which began enrollment in September 2023

CAMBRIDGE, Mass., Dec. 21, 2023 (GLOBE NEWSWIRE) -- Apnimed, Inc., a clinical-stage pharmaceutical company focused on developing oral pharmacologic therapies for the treatment of obstructive sleep apnea (OSA) and related disorders, today announced the first patient dosed in its SynAIRgy Phase 3 study designed to examine the efficacy and safety of AD109 (aroxybutynin/atomoxetine) compared to placebo at six-months. AD109 has the potential to be the first nighttime oral pharmacologic treatment for people with OSA who are either intolerant of or refuse to use positive airway pressure (PAP) therapy.

Currently, fewer than half of the people using PAP therapy are compliant long-term, leaving many people at risk from the consequences of untreated OSA, including a higher risk for stroke and heart attack.

“Together, LunAIRo and SynAIRgy represent the largest ever prospective evaluations of a novel pharmacologic for OSA,” said Larry Miller, M.D., Chief Executive Officer of Apnimed. “These trials are a major step in developing a potential treatment that meets the needs of patients who have limited or no other options. It's vital to discover and test alternative treatments for people with OSA to potentially help improve their quality of life both at night and during the day. Based on the results, AD109 has the potential to be a major advance in how we treat OSA. Topline results from the Phase 3 program of AD109 are expected in the first half of 2025.”

About the SynAIRgy Study
The SynAIRgy Study (clinicaltrials.gov identifier NCT05813275) is a randomized, double blind, placebo-controlled, parallel-arm 6-month study of a fixed dose combination of aroxybutynin/atomoxetine (AD109) in participants with OSA who are intolerant of or currently refuse positive airway pressure (PAP) therapy. Participants (n=640) will be randomized 1:1 to either AD109 or placebo. The primary endpoint is designed to show that AD109 is safe and superior to placebo in reduction of airway obstructions (AHI4). A key secondary endpoint is determining whether AD109 is superior to placebo for OSA symptoms based on the PROMIS-Fatigue scale. Other standard objective and subjective metrics of OSA will also be evaluated. The trial will include up to 65 enrolling centers across the US and Canada. Interested participants may check their eligibility at sleepapneatrial.com

About AD109
AD109 has the potential to be the first oral pharmacologic that could both treat the underlying nighttime airway obstruction and hypoxia that characterize OSA, as well as improve the daytime consequences of OSA, such as fatigue. It is a first-in-class, novel, investigational combination dosed once daily at bedtime and is designed to treat OSA patients across a broad spectrum of disease severity. AD109 combines Apnimed’s novel selective antimuscarinic (aroxybutynin) with a selective norepinephrine reuptake inhibitor (atomoxetine). AD109 targets key neurological pathways in OSA that activate upper airway dilator muscles to maintain an open airway during sleep. AD109 has the potential to become a safe, effective, and convenient treatment for OSA, addressing some of the key limitations of approved treatments that can be poorly tolerated (e.g., CPAP and oral devices) and/or invasive (e.g., surgery or implanted devices).

AD109 has been granted Fast Track designation by the FDA and is currently in Phase 3.

About Obstructive Sleep Apnea        
Obstructive Sleep Apnea is one of the most common and serious sleep disorders. It is estimated to affect more than 45 million Americans, though underdiagnosis continues to be a serious problem and the number of affected Americans may be far greater. OSA is characterized by partial or complete upper airway closure that occurs during sleep, which can cause dramatic reductions in overnight oxygen saturation and often leads to poor sleep, and in the long term, has been shown to exacerbate hypertension, diabetes, cardiovascular disease, and stroke. Additionally, OSA can impair work productivity, reduce daytime functional abilities, and lower quality of life. Sleep-related muscular relaxation driven by the central nervous system is the key neurologic mechanism that causes OSA. In patients with OSA, a reduction in neuromuscular control of the upper airway during sleep leads to a corresponding relaxation of the upper airway dilator 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. Some OSA patients are overweight or obese, and sustained weight loss can reduce the severity of airway collapse and some symptoms. However, even substantial weight loss has not been shown to be curative in most patients or reduce the need for treatments that help maintain an open airway during sleep.

About Apnimed
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 could benefit from treatment with a safe and effective oral medication dosed once daily at bedtime. Apnimed’s lead development program targets the neurologic control of upper airway muscles to maintain an open airway during sleep. 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 or follow us on X and LinkedIn.

Media Contact:
Amanda Breeding

Investor Contact:
Wendy Gabel
Kendall Investor Relations