Apnimed Announces Strong Lineup of Presentations at SLEEP 2024, Including Obesity Analysis in OSA

Apnimed, Inc., a pharmaceutical company dedicated to advancing oral treatments for obstructive sleep apnea (OSA) and other sleep disorders, is set to present significant findings at the SLEEP 2024 annual meeting. The event will feature five data presentations and a symposium dinner, underscoring Apnimed's efforts to tackle the neuromuscular causes of OSA beyond traditional weight loss methods.

A critical study to be presented highlights that most individuals with OSA are not obese, challenging common assumptions about the disorder's primary causes. Apnimed's CEO, Larry Miller, emphasizes the importance of addressing the neuromuscular roots of OSA, particularly through their innovative drug, AD109, which is currently in Phase 3 clinical development. This oral nighttime medication aims to serve a diverse range of OSA patients by targeting the neuromuscular pathways that lead to airway collapse during sleep.

The SLEEP 2024 meeting, organized by the American Academy of Sleep Medicine and the Sleep Research Society, is scheduled from June 1-5 at the George R. Brown Convention Center in Houston. Apnimed's presentations will include both oral and poster discussions on various aspects of their pipeline, including the SynAIRgy Phase 3 study for AD109 and the VicTor Study related to another developmental candidate, AD817.

During the meeting, Apnimed will also host a symposium titled "Shining a Light on Living with Sleep Apnea." This event will feature a preview of the film "Out of Breath," which documents the challenges faced by individuals living with OSA, followed by a panel discussion.

The SynAIRgy Study (NCT05813275) is a rigorous Phase 3 trial evaluating the efficacy of AD109, a combination of aroxybutynin and atomoxetine, in patients who do not tolerate or refuse positive airway pressure (PAP) therapy. The study aims to enroll 640 participants across the U.S. and Canada, with the primary goal of reducing airway obstructions caused by OSA. A secondary goal is to assess improvements in fatigue symptoms using the PROMIS-Fatigue scale. Notably, an additional cohort will examine the effects of AD109 in conjunction with a GLP-1 agonist for weight loss.

AD109 is positioned to potentially become the first oral medication to address both the nighttime airway obstruction and daytime fatigue associated with OSA. By combining a selective antimuscarinic (aroxybutynin) with a selective norepinephrine reuptake inhibitor (atomoxetine), AD109 targets neurological pathways that maintain an open airway during sleep. This innovative approach could provide a more convenient and tolerable alternative to current treatments like CPAP and surgical interventions, which many patients find challenging.

The VicTor Study (NCT05793684) is another essential trial in Apnimed's portfolio, exploring a combination of viloxazine and trazodone in OSA patients. This Phase 2 study is designed as a randomized, double-blind, placebo-controlled crossover trial to compare the efficacy of the drug combination versus viloxazine alone and placebo.

OSA is a prevalent and serious sleep disorder, affecting an estimated 50 to 80 million Americans. The condition is characterized by repeated collapse of the upper airway during sleep, leading to significant drops in oxygen levels, poor sleep quality, and increased risks of hypertension, diabetes, cardiovascular disease, and stroke. Traditional treatments often involve PAP devices, which are effective but have low long-term compliance due to discomfort. Weight loss can alleviate some symptoms, but it is not a comprehensive solution, particularly if the patient regains weight.

Apnimed's mission is to revolutionize OSA treatment with safe and effective oral medications that can be taken once daily at bedtime. Their lead program, AD109, focuses on maintaining open airways by targeting neurological control of the upper airway muscles. With ongoing clinical trials and a robust pipeline of pharmacologic therapies, Apnimed aims to provide new hope for OSA patients who struggle with current treatment options.