CAMBRIDGE, Mass. October 18, 2023 – Apnimed, a clinical-stage pharmaceutical company focused on developing oral pharmacologic therapies for the treatment of obstructive sleep apnea (OSA) and related disorders, announced that recent data on AD109 (aroxybutynin/atomoxetine) will be featured in an oral presentation at World Sleep 2023 symposium in Rio de Janeiro, Brazil. AD109 is a potential first-in-class, novel pharmacologic that is specifically designed to target the key neurological pathways in OSA that activate upper airway dilator muscles to maintain an open airway during sleep. It is currently in Phase 3 clinical trials.
“People with obstructive sleep apnea from around the world need a safe and effective oral medication that can be taken at bedtime to address the underlying biology of the disorder,” said Larry Miller, MD, Chief Executive Officer of Apnimed. “We are excited to share the latest data on our lead investigational candidate AD109 and discuss how this potential novel pharmacologic therapy may help people with mild, moderate and severe OSA.”
Symposium: Clinical trials in sleep – disordered breathing: What have we learned and where
do we go from here?
Presentation: Pharmacologic approaches to treatment of obstructive sleep apnea
Time: Tuesday, October 24 from 11:35 – 11:51 am BRT
Location: Room 24, Windsor Convention & Expo Center
Presenter: Luigi Taranto Montemurro, MD, Chief Scientific Officer, Apnimed
AD109 has the potential to be the first oral pharmacologic that could both treat the underlying nighttime airway obstruction and hypoxia that characterize OSA, as well as improve the daytime consequences of OSA, such as fatigue. It is a first-in-class, novel, investigational combination dosed once daily at bedtime and is designed to treat OSA patients across a broad spectrum of disease severity. AD109 combines Apnimed’s novel selective antimuscarinic (aroxybutynin) with a selective norepinephrine reuptake inhibitor (atomoxetine). AD109 targets key neurological pathways in OSA that activate upper airway dilator muscles to maintain an open airway during sleep. AD109 has the potential to become a safe, effective, and convenient treatment for OSA, addressing some of the key limitations of current standard of care treatments that can be poorly tolerated (e.g., CPAP and oral devices) and/or invasive (e.g., surgery or implanted devices).
AD109 has been granted Fast Track designation by the FDA and is currently in Phase 3.
About Obstructive Sleep Apnea
Obstructive Sleep Apnea is one of the most common and serious sleep disorders. It is estimated to affect more than 45 million Americans, though underdiagnosis continues to be a serious problem and the number of affected Americans may be far greater. OSA is characterized by partial or complete upper airway closure that occurs during sleep, which can cause dramatic reductions in overnight oxygen saturation and often leads to poor sleep, and in the long term, has been shown to exacerbate hypertension, diabetes, cardiovascular disease, and stroke. Additionally, OSA can impair work productivity, reduce daytime functional abilities, and lower quality of life. Sleep-related muscular relaxation driven by the central nervous system is the key neurologic mechanism that causes OSA. In patients with OSA, a reduction in neuromuscular control of the upper airway during sleep leads to a corresponding relaxation of the upper airway dilator muscles. The vast majority of diagnosed patients are prescribed positive air pressure therapy devices such as continuous positive airway pressure, or CPAP, but many patients are dissatisfied with these mechanical nighttime devices and fewer than half are compliant long term, leaving a significant population untreated, undertreated and at risk.
Apnimed is a clinical-stage pharmaceutical company working to transform the treatment of sleep apnea based on a simple idea – patients with obstructive sleep apnea could benefit from treatment with a safe and effective oral medication dosed once daily at bedtime. Apnimed’s lead development program targets the neurologic control of upper airway muscles to maintain an open airway during sleep. Based in Cambridge, Mass., the company is developing a portfolio of novel pharmacologic therapies for sleep apnea and related disorders. Learn more at apnimed.com or follow us on X and LinkedIn.
Kendall Investor Relations