Apnimed announced the early completion of enrollment for its phase 3 trial to evaluate the efficacy and safety of AD109 for obstructive sleep apnea.
RT’s Three Key Takeaways:
- Apnimed completed early enrollment in its phase 3 SynAIRgy study to evaluate AD109 as an oral therapy for OSA.
- AD109 is intended to improve oxygenation during sleep by directly addressing the underlying neuromuscular cause of upper airway collapse in people with OSA
- Apnimed’s trials have generated strong interest, with over 25,000 people expressing interest in participating in the SynAIRgy study, according to the company.
Apnimed Inc, a pharmaceutical company focused on developing oral therapies that address the neuromuscular dysfunction of obstructive sleep apnea (OSA) and other sleep-related breathing diseases, announced the early completion of enrollment in its SynAIRgy phase 3 study.
SynAIRgy is designed to examine the efficacy and safety of Apnimed’s lead candidate AD109 (aroxybutynin/atomoxetine) compared to placebo at six months in adults with mild, moderate and severe OSA.
Earlier this year, Apnimed also completed enrollment for its LunAIRo phase 3 Study examining AD109 in OSA. Topline phase 3 data for both the SynAIRgy and LunAIRo studies are expected in mid-2025.
AD109 has the potential to become the first pharmacological treatment to improve oxygenation during sleep by directly addressing the underlying neuromuscular cause of upper airway collapse in people with OSA, according to a release from Apnimed.
“We believe the strong interest we have seen throughout the SynAIRgy study is telling of the sleep community’s desire for new treatment options,” says Patrick Strollo, Jr, MD, chairman of the SynAIRgy clinical study and vice chair of medicine for Veterans Affairs at the University of Pittsburgh School of Medicine, in a release. “Millions of people living with OSA refuse, abandon, or are dissatisfied with their current treatment, and this phase 3 trial offers them new hope.”
Strong Interest in Phase 3 Study
Over 25,000 people expressed interest in trial participation in the SynAIRgy study, according to the company. Apnimed notes that its site selection process across the US and Canada at centers of excellence and academic institutions facilitated diverse enrollment by race, gender, and location in 73 trial sites across both countries. To ensure diverse representation in its trials, Apnimed leveraged a variety of grassroots initiatives and engaged directly with patient advocacy groups and representatives of minority communities.
“We are deeply grateful to the patients who have chosen to participate in our phase 3 studies. Their commitment brings us one step closer to a potential breakthrough in the treatment of OSA,” says Larry Miller, CEO of Apnimed, in a release. “We believe that AD109 has the potential to become the first oral therapy to address the neuromuscular cause of OSA, which could redefine the standard of care and offer a new, simpler solution for millions of people living with this disease.”
ID 202731652 © Bntsbkst | Dreamstime.com
