Apnimed right now introduced constructive topline outcomes from the LunAIRo examine, its second pivotal section 3 scientific trial of their lead candidate, AD109 (aroxybutynin 2.5 mg/atomoxetine 75 mg) for obstructive sleep apnea (OSA).
AD109 is a first-in-class, anti-apneic neuromuscular modulator that targets the basis reason behind OSA by growing higher airway muscle tone throughout sleep. It’s designed to be a once-daily capsule taken at bedtime.
“Given the size of unmet want in OSA, the place nearly all of sufferers stay untreated, we consider AD109, as a easy once-daily oral drug, has the potential to increase and reshape the therapy panorama,” stated Larry Miller, MD, chief government officer of Apnimed.1
The LunAIRo examine is a 12-month randomized, double blind, placebo-controlled, parallel-arm, 1-year scientific trial of AD109, with an investigational mounted dose mixture of aroxybutynin 2.5 mg/atomoxetine 75 mg, in contributors with OSA who can’t tolerate or presently refuse steady constructive airway strain remedy. Investigators enrolled a various vary of 660 grownup contributors from 64 facilities within the US, who had been randomly assigned 1:1 to both AD109 or placebo (AD109, n=329; placebo, n=331) and instructed to take their assigned therapy once-daily earlier than bedtime. Individuals included 46% females, a number of racial teams, and different weight lessons. Moreover, the contributors represented a variety of OSA severity, together with delicate (37%), average (33%), and extreme (30%) ranges.
LunAIRo met its major endpoint, demonstrating clinically significant and statistically vital reductions in airway obstruction at 26 weeks. Individuals handled with AD109 achieved a imply discount within the Apnea-Hypopnea Index (AHI) of 46.8% from baseline at week 26 (vs 6.8% with placebo; P<0.001). The discount in AHI remained vital at finish of examine (week 51, P<0.001).
As to security profile, AD109 was usually well-tolerated, with the most typical treatment-emergent adversarial occasions being delicate or average in severity, and per prior research. No severe adversarial occasions associated to AD109 had been reported.
The LunAIRo topline outcomes are per the earlier constructive topline outcomes from the SynAIRgy section 3 scientific trial, which was a randomized, double blind, placebo-controlled, parallel-arm 6-month scientific trial of AD109 in contributors with OSA who can’t tolerate or presently refuse steady constructive airway strain remedy. The trial enrolled 646 grownup contributors who had been randomly assigned 1:1 to both AD109 or placebo. It met its major endpoint of imply change from baseline within the AHI at 26 weeks in contrast with placebo (P=0.001).2
“The consistency of the promising findings throughout each the LunAIRo and SynAIRgy trials supplies strong scientific proof that AD109 meaningfully improved sleep apnea severity and oxygenation,” stated Sanjay Patel, MD, examine chair for the LunAIRo scientific trial and director of the UPMC Complete Sleep Issues Medical Program in Pittsburgh, Pennsylvania. “That is the primary time we’ve seen a once-daily oral treatment exhibit such vital, sturdy results in a broad affected person inhabitants with OSA.”1
Investigators are nonetheless analyzing extra goal, subjective, and exploratory endpoints and security information from the LunAIRo and SynAIRgy research, and are anticipated to report this evaluation at a medical congress later this 12 months.
“With 2 giant section 3 research now demonstrating a constant and vital efficacy profile for AD109, we’re nearer to delivering the primary oral pharmacotherapy for over 80 million US adults with OSA,” stated Miller. “Primarily based on the section 3 information from LunAIRo and SynAIRgy, Apnimed plans to file a New Drug Software (NDA) with the US FDA in early 2026. As we put together for FDA regulatory submitting and commercialization of AD109, we’re targeted on guaranteeing we’ve the capabilities, individuals, and partnerships in place to deliver this progressive drug to sufferers affected by OSA and the clinicians who deal with them.”1
AD109 additionally demonstrated enhancements in extra topline secondary and exploratory endpoints within the LunAIRo examine, similar to significant enhancements in oxygenation as assessed by reductions in hypoxic burden (P<0.0001) and oxygen desaturation index (P<0.001) at week 26 and at finish of examine (week 51). A big proportion of contributors additionally achieved a ≥50% discount in AHI from baseline at week 26 (P<0.0001) and at week 51 (P<0.0001). Notably, AD109 improved OSA illness severity for 45.0% of contributors at week 26 and 47.5% at week 51; and AD109 achieved OSA full illness management (AHI<5) for 22.9% of contributors at week 26 and 22.5% at week 51.
“The huge variety of individuals presently residing with untreated OSA factors to a necessity for extra therapy choices. As somebody residing with OSA, the LunAIRo examine provides me hope that novel pharmacotherapy therapies are on the horizon and may doubtlessly enhance so many lives,” stated Emma Cooksey, a affected person advocate and sleep apnea program supervisor at Undertaking Sleep. “Innovation on this area is lengthy overdue, and it’s encouraging to see significant progress being made.”1
“We’re particularly grateful to the examine contributors, the investigators, and the examine websites that contributed to our AD109 section 3 scientific program. Their partnership and belief have been instrumental in advancing a brand new strategy to OSA—one which has the opportunity of altering how this persistent illness is handled,” concluded Miller.1
References
1. Apnimed reviews constructive topline outcomes from second section 3 trial of AD109, reinforcing potential of first oral capsule for obstructive sleep apnea. Information launch. July 23, 2025. Accessed July 23, 2025. https://apnimed.com/article/ad109toplinephase3results/
2. Apnimed publicizes constructive topline leads to the primary landmark section 3 scientific trial of AD109, an investigational once-daily oral capsule for obstructive sleep apnea. Information launch. Might 19, 2025. Accessed July 23, 2025. https://apnimed.com/article/ad109phase3toplineresults/
