Phase 3 Enrollment Complete for Apnimed's AD109, a Novel Nighttime Oral OSA Treatment

A clinical-stage pharmaceutical company, Apnimed, has announced the early completion of enrollment for its LunAIRo Phase 3 study, which is evaluating a new oral drug candidate, AD109, for the treatment of obstructive sleep apnea (OSA). The study aims to assess the efficacy and safety of AD109 compared to a placebo over a period of six months and one year. The drug is being developed as a potential first oral treatment for OSA patients who are unable to tolerate or refuse positive airway pressure (PAP) therapy.

OSA is a prevalent sleep disorder affecting an estimated 50 to 80 million people in the United States and nearly a billion worldwide. Despite its prevalence, OSA remains largely underdiagnosed and undertreated, underscoring the need for innovative treatment options. The condition can significantly impair daily functioning and increase the risk of serious health issues such as hypertension, diabetes, cardiovascular disease, and stroke.

The LunAIRo study is designed to assess AD109's ability to address the neurobiology of OSA by stimulating the upper airway muscles to maintain an open airway during sleep. The study's primary investigator, Dr. Sanjay R. Patel, highlights the urgent need for new treatment options, given that less than half of those prescribed PAP therapy consistently use it long-term, and many others are unable or unwilling to use it.

The LunAIRo Phase 3 study is a randomized, double-blind, placebo-controlled, parallel-arm study that will examine AD109's effects on a diverse range of OSA patients, including those with mild to severe conditions and varying body mass index (BMI) levels. The study's primary endpoint is to demonstrate AD109's safety and efficacy in reducing airway obstructions, with a key secondary endpoint focusing on symptom improvement based on the PROMIS-Fatigue scale.

Apnimed's CEO, Dr. Larry Miller, has expressed excitement about the early completion of the LunAIRo study's enrollment, noting the strong interest from both clinicians and patients in innovative OSA treatments. The company believes that AD109 represents a significant market opportunity, with the potential to assist a wide range of OSA patients.

AD109 is a novel, once-daily, bedtime medication that combines a selective antimuscarinic with a selective norepinephrine reuptake inhibitor. It targets neurological pathways in OSA to activate upper airway muscles, offering a potential safe, effective, and convenient treatment option. The drug has been granted Fast Track designation by the FDA and is currently in Phase 3 clinical trials.

Apnimed is dedicated to transforming sleep apnea treatment with safe and effective oral medications. The company's lead program, AD109, is part of a broader pipeline of novel pharmacologic therapies for sleep apnea and related disorders. Apnimed is based in Cambridge, Massachusetts, and is developing a range of innovative treatments in partnership with Shionogi & Co., Ltd. through their joint venture, Shionogi-Apnimed Sleep Science, LLC.