Paula Schweitzer, PhD: AD109 Demonstrates Significant Reduction of AHI4

"This is the first large, long-duration study, and it's really encouraging that we are seeing results that don't just last one night and that last over time," Paula Schweitzer, PhD, study investigator and director of research at St. Luke’s Sleep Medicine and Research Center, said in an interview with HCPLive.

During the "Breaking News in OSA Mini Symposium" at the American Thoracic Society (ATS) 2023 International Conference in Washington, DC, she revealed new data from the MARIPOSA phase 2b trial were disclosed. The trial evaluated the effectiveness, safety, and optimal dosage of AD109 (aroxybutynin + atomoxetine), an oral treatment for individuals with obstructive sleep apnea.

"It's got the potential to treat mild, moderate, and severe sleep apnea and that is encouraging and worth developing."

Apnimed, the development company, reported that AD109 showcased a noteworthy decrease in AHI4 (P < 0.001) in comparison with placebo, and statistical significance was observed at both tested doses. These findings indicated the drug's efficacy in reducing AHI and potentially alleviating daytime fatigue.

"I think it has great potential in being another tool in the treatment toolbox," she explained. "I think it's going to be especially useful for those patients who are unable to tolerate or use the primary treatment that we have currently–CPAP."

Apnimed stated the plan is to commence a pair of phase 3 registration trials in the latter half of 2023.