– SynAIRgy Compares AD109 to Placebo Over 6 Months in People with OSA who Are Intolerant of or Refuse Positive Airway Pressure (PAP) Therapy, the Current Standard of Care
– Part of a two-study registrational Phase 3 program that also includes LunAIRo which began enrollment in September 2023
CAMBRIDGE, Mass., December 21, 2023 – Apnimed, Inc., a clinical-stage pharmaceutical company focused on developing oral pharmacologic therapies for the treatment of obstructive sleep apnea (OSA) and related disorders, announced the first patient dosed in its SynAIRgy Phase 3 study designed to examine the efficacy and safety of AD109 (aroxybutynin/atomoxetine) compared to placebo at six-months. 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.
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.
“Together, LunAIRo and SynAIRgy 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. 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 advance in how we treat OSA. Topline results from the Phase 3 program of AD109 are expected in the first half of 2025.”... Apnimed's Press Release -
