– Apnimed to Present Rationale and Design of LunAIRo Phase 3 Study for AD109 at the ATS 2024 International Conference
– Topline Phase 3 Data Expected in Mid-2025
CAMBRIDGE, Mass., May 09, 2024 (GLOBE NEWSWIRE) — Apnimed, a clinical-stage pharmaceutical company focused on developing oral pharmacologic therapies for the treatment of obstructive sleep apnea (OSA) and related disorders, announced the early completion of enrollment in its LunAIRo Phase 3 study designed to examine the efficacy and safety of its lead candidate AD109 (aroxybutynin/atomoxetine) compared to placebo at six months and one year. The company believes 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. Apnimed’s second, large pivotal Phase 3 randomized controlled trial, SynAIRgy, is continuing its enrollment. Topline Phase 3 data for both LunAIRo and SynAIRgy are expected in Mid-2025.
OSA is one of the most common and serious sleep disorders, affecting more than 50 million and as many as 80 million people in the United States and nearly one billion worldwide. Unlike many other common chronic disorders, OSA is vastly underdiagnosed and undertreated, representing a major potential opportunity to build awareness driven by new innovations in the field. OSA significantly impairs daily function and increases one’s risk for serious comorbidities like hypertension, diabetes, cardiovascular disease and stroke.
“There are no FDA-approved drugs currently available to address the neuromuscular dysfunction that causes OSA. The LunAIRo Study is designed to evaluate the potential of AD109 to address the underlying neurobiology of OSA by activating the upper airway muscles and maintaining an open airway during sleep,” said Sanjay R. Patel, MD, primary investigator in the LunAIRo clinical study and Director, UPMC Comprehensive Sleep Disorders Clinical Program in Pittsburgh, Pennsylvania. “Because fewer than half of the people who are prescribed devices such as PAP therapy consistently use them long term and many others cannot or will not use them, new options are urgently needed to address the chronic undertreatment of OSA among millions of Americans.”
LunAIRo at ATS 2024 International Conference
The rationale and design of the LunAIRo Phase 3 Study will be featured in a poster presentation 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 1-year study of AD109 in adults with OSA who are intolerant of or refuse PAP therapy. The LunAIRo study examines the use of AD109 in a range of OSA patients across all types of OSA from mild to severe and ranges of body mass index (BMI) from normal to obese.
“We completed the enrollment of LunAIRo ahead of schedule, signaling that there is strong interest in innovative new approaches to treating OSA among both clinicians and people with OSA,” said Larry Miller, MD, Chief Executive Officer of Apnimed. “Studying AD109 across a broad range of people who have OSA is an important consideration in the LunAIRo Study. We believe AD109 represents a significant market opportunity, with the potential to help patients with OSA across a broad spectrum of severity and BMI.”[***]
