At CHEST, the company released additional data from its pivotal phase 3 SynAIRgy and LunAIRo trials evaluating the investigational drug, AD109.
Apnimed Inc released additional data from its pivotal phase 3 SynAIRgy and LunAIRo trials evaluating the investigational drug, AD109 (aroxybutynin 2.5 mg/atomoxetine 75 mg) at the CHEST Annual Meeting earlier this month.
The additional data built on previously reported topline results show that both studies met their primary endpoint, reduction in apnea-hypopnea index (AHI) at 26 weeks, and across both studies, AD109 demonstrated clinically meaningful improvements in oxygenation, including significant reductions in the oxygen desaturation index (ODI) and hypoxic burden (HB) compared with placebo. These results provide additional support for how AD109, an investigational, once-nightly oral pill, can address both the sleep-related neuromuscular dysfunction and oxygenation deficits underlying the disease.
“The consistency of these findings underscores what we’ve theorized from the start: restoring oxygenation is key to helping people with OSA,” says Larry Miller, MD, Apnimed CEO, in a release. “As we move toward NDA submission, we’re not only demonstrating the strength of our science but also building the foundation to deliver AD109 as a potential new oral option for the many people who are unable or unwilling to use existing therapies. Our goal is to expand the range of effective treatments available so more individuals with OSA can find a solution that works for them.”
Select SynAIRgy Phase 3 Results
In the modified intention-to-treat population, AD109 achieved a significant reduction in mean AHI from baseline (55.6%) compared to placebo (19.1%) at 26 weeks. AD109 also demonstrated improvements in key secondary and exploratory endpoints at week 26, including:
- Significant improvements in oxygenation as assessed by mean reductions in hypoxic burden (60.5%) and oxygen desaturation index (44.8%)
- Significant proportion with reductions of AHI ≥50% (39.6%)
- 51.2% of participants treated with AD109 showed a reduction in OSA disease severity category
- 22.3% of participants treated with AD109 achieved complete OSA disease control (defined as AHI <5 events/hour)
- AD109 was generally well-tolerated, with the most common adverse events being dry mouth, insomnia, and nausea, and no treatment-related serious adverse events were reported
Select LunAIRo Phase 3 Results
In the modified intention-to-treat population, AD109 achieved a significant reduction in mean AHI from baseline (46.8%) compared to placebo (6.8%, p<0.001) at 26 weeks. AD109 also demonstrated improvements in key secondary and exploratory endpoints at week 26, including:
- Significant improvements in oxygenation as assessed by mean reductions in hypoxic burden (58.2%) and oxygen desaturation index (40.3%)
- Significant proportion with reductions of AHI ≥50% (38.3%)
- 45.0% of participants treated with AD109 showed a reduction in OSA disease severity category
- 22.9% of participants treated with AD109 achieved complete OSA disease control
- AD109 was generally well-tolerated, with the most common adverse events being dry mouth, insomnia, and nausea. No treatment-related serious adverse events were reported
“What’s particularly encouraging about these findings is the improvement in oxygenation — a fundamental biomarker of how well the body is protected during sleep,” says Patrick J Strollo, Jr., MD, study chair of the SynAIRgy clinical trial and vice chair of medicine for Veteran’s Affairs at the University of Pittsburgh School of Medicine, in a release. “In addition to the previously reported significant reductions in AHI, these new data add to the robust AD109 results and suggest that, if approved, it may offer a new way to manage OSA by directly targeting the physiological impact of the disease.”
