Apnimed to Showcase Phase 3 Data for Groundbreaking Sleep Apnea Treatment at CHEST 2025

Apnimed to Present Groundbreaking Data at CHEST 2025

Overview

On October 19-22, 2025, Apnimed Inc. will reveal pivotal data from its Phase 3 clinical trials for AD109, a novel oral treatment aimed at obstructive sleep apnea (OSA), during the CHEST Annual Meeting in Chicago, IL. This presentation will shed light on the largest clinical program assessing an experimental drug for this widespread condition affecting over 80 million in the U.S.

Clinical Trial Results

The studies, known as SynAIRgy and LunAIRo, focused on the efficacy of AD109 (combining aroxybutynin and atomoxetine), revealing promising outcomes. The key highlight is a significant reduction in the apnea-hypopnea index (AHI) over 26 weeks, with AD109 achieving a 55.6% decrease compared to 19.1% for the placebo group in the SynAIRgy trial. Key secondary endpoints related to oxygenation, including oxygen desaturation index (ODI3) and hypoxic burden (HB4), also showed impressive reductions.

Dr. Larry Miller, CEO of Apnimed, emphasized the importance of restoring oxygenation as crucial for managing OSA. These new findings support AD109's potential to serve as a primary therapy choice, especially for individuals who find existing treatments challenging.

Detail of Study Findings

SynAIRgy Trial Insights

1. Reduction in AHI: The mITT population experienced significant AHI reductions with AD109 (55.6%, p<0.0001).
2. Oxygenation Improvement: Noteworthy reductions were observed in hypoxic burden (60.5%, p<0.0001) and ODI3 (44.8%, p<0.0001).
3. Patient Outcomes: 39.6% of participants had a greater than 50% reduction in AHI, and 22.3% achieved complete control of OSA, defined as an AHI of less than 5 events/hour.
4. Tolerability: While generally well-tolerated, the most reported side effects included dry mouth, insomnia, and nausea.

LunAIRo Trial Insights

In the LunAIRo trial, AD109 also exhibited a significant mean AHI reduction of 46.8% versus 6.8% for placebo, reinforcing the efficacy observed in SynAIRgy. Important secondary endpoint results consistent with the first study included:
1. Oxygenation Metrics: Achieving a hypoxic burden reduction of 58.2% (p<0.0001) and an ODI3 decrease of 40.3% (p<0.001).
2. Participant Outcomes: Similar proportions of participants experienced AHI reductions of at least 50% (38.3%) and complete OSA control (22.9%).

Implications for Treatment

Apnimed’s AD109 aims to target the neuromuscular dysfunction linked to OSA, presenting itself as a more straightforward alternative compared to continuous positive airway pressure (CPAP) machines. Patrick J Strollo, Jr., MD, highlighted the substantial findings surrounding oxygenation as a critical health marker during sleep. If approved, AD109 could reshape OSA management strategies, offering an easier administration route while addressing the core problem of upper airway collapse.

Conclusion

As Apnimed progresses toward a New Drug Application (NDA) with the U.S. FDA, these latest findings not only validate the potential of AD109 as a treatment option for millions suffering from OSA but also demonstrate the company’s commitment to advancing innovative and accessible therapies. With ongoing developments in sleep apnea treatment, the future looks promising for patients seeking effective solutions.

For updates from Apnimed and their detailed presentation schedule at the CHEST Annual Meeting, visit their official website or follow them on LinkedIn.