AD109 Cuts Sleep Apnea Events 44% in Phase 3 Trial as 18% Reach Full Control
Updated
Updated · SciTechDaily · Jun 2
AD109 Cuts Sleep Apnea Events 44% in Phase 3 Trial as 18% Reach Full Control
3 articles · Updated · SciTechDaily · Jun 2
646 adults with mild to severe obstructive sleep apnea who could not tolerate or chose not to use CPAP took part in the six-month SynAIRgy trial across 69 U.S. and Canadian sites.
AD109 reduced the apnea-hypoxia index by about 44%, versus an 18% drop with placebo, while also improving oxygen desaturation and overall blood oxygen levels.
More than 40% of treated patients moved to a lower disease-severity category, and 18% achieved complete disease control, with benefits seen across body types and baseline severity levels.
21% of participants stopped treatment because of side effects, which researchers said were mostly mild and expected, including dry mouth, nausea, insomnia and difficulty urinating.
Apnimed has already filed AD109 with the FDA after receiving Fast Track status, and expects a potential agency decision in the first quarter of 2027 if the application is accepted.
Apnimed's new pill targets sleep apnea's root cause. Could this one drug disrupt the entire billion-dollar sleep treatment industry?
With one in five users quitting due to side effects, can a new sleep apnea pill truly replace the cumbersome CPAP machine?
AD109 Achieves Significant AHI Reduction in Phase 3 Trials: A Paradigm Shift for OSA Management
Overview
Apnimed Inc. has achieved a major milestone by reporting positive Phase 3 trial results for AD109, an oral treatment targeting the neuromuscular root cause of obstructive sleep apnea (OSA). This success marks a significant step forward in drug development and positions AD109 as a strong candidate for regulatory approval. For years, OSA treatment options have been limited, leaving many patients without effective solutions. AD109 stands out as it could become the first oral pill specifically designed for OSA, offering hope for a much-needed innovation and a new, convenient alternative for those struggling with current therapies.