– 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
Apnimed, Inc., 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.”
About the SynAIRgy Study
The SynAIRgy Study (clinicaltrials.gov identifier NCT05813275) is a randomized, double blind, placebo-controlled, parallel-arm 6-month study of a fixed dose combination of aroxybutynin/atomoxetine (AD109) in participants with OSA who are intolerant of or currently refuse positive airway pressure (PAP) therapy. Participants (n=640) will be randomized 1:1 to either AD109 or placebo. The primary endpoint is designed to show that AD109 is safe and superior to placebo in reduction of airway obstructions (AHI4). A key secondary endpoint is determining whether AD109 is superior to placebo for OSA symptoms based on the PROMIS-Fatigue scale. Other standard objective and subjective metrics of OSA will also be evaluated. The trial will include up to 65 enrolling centers across the US and Canada. Interested participants may check their eligibility at sleepapneatrial.com.
Source: Apnimed
