The first patient has been dosed in Apnimed’s LunAIRo phase 3 study designed to examine the efficacy and safety of AD109 compared to placebo at six months and one year in people with obstructive sleep apnea (OSA) who are intolerant of or refuse to use positive airway pressure (PAP) therapy.
AD109 (aroxybutynin/atomoxetine) has the potential to be the first nighttime oral pharmacologic treatment for this patient population.
“There is an urgent need for new treatment options for people with OSA, particularly those who cannot tolerate currently available therapies,” says Sanjay Patel, MD, primary investigator in the LunAIRo clinical study and director of the University of Pittsburgh Medical Center Comprehensive Sleep Disorders Clinical Program, in a release. “It’s vital to discover and test alternative treatments for people with OSA to potentially help improve their quality of life both at night and during the day. Based on the results, AD109 has the potential to be a major game changer in how we treat OSA.”
Currently, fewer than half of the people using PAP therapy are compliant long-term, leaving many people at risk from the consequences of untreated OSA, including a higher risk for stroke and heart attack.
“LunAIRo and SynAIRgy, our second registrational study expected to begin enrollment in the fourth quarter, represent the largest ever prospective evaluations of a novel pharmacologic for OSA,” says Larry Miller, MD, CEO of Apnimed, in a release. “These trials are a major step in developing a potential treatment that meets the needs of patients who have limited or no other options. Topline results are expected by early 2025, and with positive results, we anticipate submitting our new drug application to the FDA in the second half of 2025.”
AD109 has been granted Fast Track designation by the FDA.