Apnimed Completes Phase 3 Enrollment for AD109 Sleep Apnea Treatment Study

Apnimed, a clinical-stage pharmaceutical company based in Cambridge, Massachusetts, has announced the early completion of enrollment for its LunAIRo Phase 3 study. The study aims to assess the efficacy and safety of their leading candidate, AD109 (aroxybutynin/atomoxetine), in comparison to a placebo over six months and one year. AD109 has the potential to be the first oral pharmacologic treatment for obstructive sleep apnea (OSA) suitable for patients intolerant of or unwilling to use positive airway pressure (PAP) therapy.

OSA is a widespread and serious sleep disorder affecting over 50 million people in the United States and nearly one billion globally. The disorder is often underdiagnosed and undertreated, posing significant risks such as hypertension, diabetes, cardiovascular disease, and stroke. Traditional treatments like CPAP devices have low long-term compliance, with fewer than half of the prescribed users continuing their use consistently.

The LunAIRo Phase 3 study is critical as it investigates AD109's ability to address the neuromuscular dysfunction causing OSA. Dr. Sanjay R. Patel, the primary investigator of the LunAIRo study and Director of the UPMC Comprehensive Sleep Disorders Clinical Program in Pittsburgh, Pennsylvania, emphasized the need for new treatment options. He noted that many patients cannot tolerate or refuse PAP therapy, underscoring the urgency for innovative solutions like AD109.

The study's design, rationale, and preliminary results will be presented at the American Thoracic Society’s (ATS) International Conference in San Diego, California, on May 20, 2024. The LunAIRo study is a randomized, double-blind, placebo-controlled, parallel-arm trial involving 660 participants with OSA who cannot tolerate PAP therapy. The study aims to show that AD109 is superior to placebo in reducing airway obstructions and improving symptoms based on the PROMIS-Fatigue scale, among other metrics.

Larry Miller, MD, Chief Executive Officer of Apnimed, highlighted the strong interest in new OSA treatments among both clinicians and patients. He pointed out that AD109 could serve a broad range of OSA patients with varying severities and body mass indexes (BMI). The study's early completion of enrollment signifies the high demand and interest in alternatives to existing OSA treatments.

AD109 is a unique combination of aroxybutynin, a selective antimuscarinic, and atomoxetine, a selective norepinephrine reuptake inhibitor. It targets key neurological pathways in OSA, aiming to activate upper airway dilator muscles to maintain an open airway during sleep. The drug is designed to be a once-daily oral medication taken at bedtime, potentially transforming OSA treatment by offering a more convenient and tolerable alternative to current therapies like CPAP and surgical options.

The LunAIRo study enrolled participants from 64 centers across the United States. The primary endpoint focuses on demonstrating the safety and efficacy of AD109 compared to a placebo in reducing airway obstructions. A key secondary endpoint involves assessing the drug's effectiveness in alleviating OSA symptoms based on the PROMIS-Fatigue scale.

Apnimed is committed to developing oral pharmacologic therapies for sleep apnea and related disorders, with AD109 being their lead program. The company’s pipeline includes several innovative oral treatments, developed in collaboration with Shionogi & Co., Ltd. through their joint venture, Shionogi-Apnimed Sleep Science, LLC.

AD109 has been granted Fast Track designation by the FDA and continues to show promise in its ongoing Phase 3 clinical trials. If successful, AD109 could become a groundbreaking treatment for OSA, addressing the unmet needs of millions of patients worldwide.