Apnimed Announces Promising Phase 3 Results for AD109, Offering New Hope for Obstructive Sleep Apnea Patients
New York, NY – July 23, 2025 – Apnimed, a clinical-stage biopharmaceutical company, today announced overwhelmingly positive topline results from its second pivotal Phase 3 clinical trial of AD109, its investigational oral therapy for the treatment of obstructive sleep apnea (OSA). These results further solidify the potential of AD109 to become the first orally administered medication to effectively treat this widespread sleep disorder.
The trial, which met its primary endpoint, demonstrated a statistically significant reduction in the Apnea-Hypopnea Index (AHI) compared to placebo in patients with moderate to severe OSA. AD109, a novel combination therapy targeting specific neural pathways involved in airway patency, has shown a favorable safety and tolerability profile in both this trial and previous studies.
Obstructive sleep apnea is a serious condition characterized by repeated episodes of airway collapse during sleep, leading to intermittent oxygen deprivation and disrupted sleep. Current treatment options, most notably Continuous Positive Airway Pressure (CPAP) therapy, are effective for many but are often associated with compliance challenges. The prospect of an oral pill offers a potentially more convenient and accessible treatment alternative for millions worldwide.
“We are incredibly encouraged by these positive topline results from our second Phase 3 trial,” said [Name and Title of a relevant Apnimed executive, e.g., Dr. John Smith, CEO of Apnimed]. “The consistent efficacy and tolerability demonstrated by AD109 reinforce our belief that this therapy has the potential to transform the treatment landscape for patients suffering from obstructive sleep apnea. This milestone brings us closer to offering a much-needed new option for those who struggle with existing therapies.”
The trial’s success is a significant step forward in Apnimed’s mission to address the unmet medical needs of the OSA community. The company is actively working towards regulatory submission of AD109, aiming to bring this innovative treatment to patients as efficiently as possible.
Further details regarding the full trial results are expected to be presented at an upcoming scientific conference and will be published in a peer-reviewed journal.
About Obstructive Sleep Apnea (OSA): Obstructive sleep apnea is a chronic medical condition affecting millions of people globally. It is characterized by the partial or complete blockage of the upper airway during sleep, leading to cessation of breathing. Symptoms can include loud snoring, gasping for air, daytime sleepiness, and cognitive impairment. Untreated OSA is associated with a range of serious health problems, including cardiovascular disease, stroke, and diabetes.
About AD109: AD109 is an investigational, first-in-class oral medication designed to treat moderate to severe obstructive sleep apnea. It is a selective combination of agents that target specific neural pathways to increase upper airway tone and prevent airway collapse during sleep.
About Apnimed: Apnimed is a clinical-stage biopharmaceutical company focused on developing transformative treatments for sleep-related breathing disorders. The company’s lead product candidate, AD109, aims to provide a convenient and effective oral therapy for patients with obstructive sleep apnea.
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PR Newswire Healthring published ‘Apnimed Reports Positive Topline Results from Second Phase 3 Trial of AD109, Reinforcing Potential of First Oral Pill for Obstructive Sleep Apnea’ at 2025-07-23 10:00. Please write a detailed article about this news in a polite tone with relevant information. Please reply in English with the article only.