Apnimed Announces First Patient Dosed in LunAIRo, the First Phase 3 Clinical Study of AD109, a Potential Nighttime Oral Treatment for Obstructive Sleep Apnea
-- LunAIRo Compares AD109 to Placebo Over 6 and 12 Months in People with OSA who Are Intolerant of or Refuse Positive Airway Pressure (PAP) Therapy, the Current Standard of Care --
-- Second registrational Phase 3 study, SynAIRgy, to begin enrollment in 4th quarter --
CAMBRIDGE, Mass., Sept. 21, 2023 (GLOBE NEWSWIRE) -- Apnimed, Inc., a clinical-stage pharmaceutical company focused on developing oral pharmacologic therapies for the treatment of obstructive sleep apnea (OSA) and related disorders, today announced the first patient dosed in its LunAIRo Phase 3 study designed to examine the efficacy and safety of AD109 (aroxybutynin/atomoxetine) compared to placebo at six-months and one year. AD109 has the potential to be the first nighttime oral pharmacologic treatment for people with OSA who are either intolerant of or refuse to use positive airway pressure (PAP) therapy.
“There is an urgent need for new treatment options for people with OSA, particularly those who cannot tolerate currently available therapies,” said Sanjay Patel, M.D., primary investigator in the LunAIRo clinical study and Director, UPMC Comprehensive Sleep Disorders Clinical Program in Pittsburgh, Pennsylvania. “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,” said Larry Miller, M.D., Chief Executive Officer of Apnimed. “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.”
About the LunAIRo study
AD109 has been granted Fast Track designation by the FDA and is currently in Phase 3.
About Obstructive Sleep Apnea