- LunAIRo, Apnimed’s second Phase 3 trial of AD109, met its primary endpoint, demonstrating a reduction in the Apnea-Hypopnea Index (AHI) from baseline at 26 weeks (p<0.001 vs. placebo); no serious adverse events related to AD109 were reported in the LunAIRo trial
- LunAIRo results were consistent with topline findings of the SynAIRgy Phase 3 trial, providing strong clinical validation of AD109 across two independent studies, marking a critical step toward expanding treatment options for people with OSA
- AD109 is a first-in-class, anti-apneic neuromuscular modulator which targets the root cause of OSA by increasing upper airway muscle tone during sleep
- Apnimed plans to submit a New Drug Application for AD109 to the U.S. Food and Drug Administration (FDA) by early 2026
Apnimed, Inc., a pharmaceutical company advancing an industry-leading pipeline of first-in-class oral therapies that address the root causes of obstructive sleep apnea (OSA) and other sleep-related breathing diseases, today announced positive topline results from its second pivotal Phase 3 clinical trial of Apnimed’s lead candidate AD109 (aroxybutynin 2.5mg/atomoxetine 75mg). LunAIRo was a 12-month study that evaluated the efficacy and safety of AD109 in adults with mild, moderate and severe OSA, across a wide range of weight classes, with the primary endpoint determined at 26 weeks.
The LunAIRo trial met its primary endpoint, demonstrating clinically meaningful and statistically significant reductions in airway obstruction at 26 weeks. Participants treated with AD109 achieved a mean reduction in AHI of 46.8% from baseline at week 26 (vs 6.8% with placebo; p<0.001). The reduction in AHI remained significant at end of study (week 51, p<0.001). AD109 was generally well-tolerated, with the most common treatment-emergent adverse events being mild or moderate in severity, and consistent with prior studies. No serious adverse events related to AD109 were reported in the LunAIRo trial.
The LunAIRo topline results align with the positive topline results previously reported from Apnimed’s SynAIRgy Phase 3 clinical trial, which the Company believes support the safety and efficacy of AD109 in treating adults with mild, moderate and severe OSA, subject to review by FDA.
“With two large Phase 3 studies now demonstrating a consistent and significant efficacy profile for AD109, we are closer to delivering the first oral pharmacotherapy for over 80 million U.S. adults with OSA. Given the scale of unmet need in OSA, where the majority of patients remain untreated, we believe AD109, as a simple once-daily oral drug, has the potential to expand and reshape the treatment landscape, which would represent a significant commercial opportunity for Apnimed. Based on the Phase 3 data from LunAIRo and SynAIRgy, Apnimed plans to file a New Drug Application (NDA) with the U.S. FDA in early 2026. As we prepare for FDA regulatory filing and commercialization of AD109, we’re focused on ensuring we have the capabilities, people, and partnerships in place to bring this innovative drug to patients suffering from OSA and the clinicians who treat them,” said Larry Miller, MD, Chief Executive Officer of Apnimed. “We’re especially grateful to the study participants, the investigators, and the study sites that contributed to our AD109 Phase 3 clinical program. Their partnership and trust have been instrumental in advancing a new approach to OSA—one that has the possibility of changing how this chronic disease is treated.”
Select Additional Results
In addition to meeting the primary endpoint, AD109 demonstrated improvements in additional topline secondary and exploratory endpoints in the LunAIRo study, including:
- Meaningful improvements in oxygenation as assessed by reductions in hypoxic burden (p<0.0001) and oxygen desaturation index (p<0.001) at week 26 and at end of study (week 51)
- A significant proportion of participants achieved a ≥50% reduction in AHI from baseline at week 26 (p<0.0001) and at week 51 (p<0.0001)
- AD109 improved OSA disease severity for 45.0% of participants at week 26, and 47.5% at week 51
- AD109 achieved OSA complete disease control (AHI<5) for 22.9% of participants at week 26, and 22.5% at week 51
Analysis of additional objective, subjective and exploratory endpoints and safety data from the LunAIRo and SynAIRgy studies are ongoing and will be reported at a medical congress later this year.
“The consistency of the promising findings across both the LunAIRo and SynAIRgy trials provides robust clinical evidence that AD109 meaningfully improved sleep apnea severity and oxygenation,” said Sanjay Patel, MD, study chair for the LunAIRo clinical trial and Director, UPMC Comprehensive Sleep Disorders Clinical Program in Pittsburgh, Pennsylvania. “This is the first time we’ve seen a once-daily oral medication demonstrate such significant, durable effects in a broad patient population with OSA.”
“The vast number of people currently living with untreated OSA points to a need for additional treatment options. As someone living with OSA, the LunAIRo study gives me hope that novel pharmacotherapy treatments are on the horizon and can potentially improve so many lives,” said Emma Cooksey, patient advocate and Sleep Apnea Program Manager at Project Sleep. “Innovation in this space is long overdue, and it’s encouraging to see meaningful progress being made.”
Discover the latest trends and insights—explore the Business Insights Journal for up-to-date strategies and industry breakthroughs!
