– New Post-Hoc Analysis of MARIPOSA Data on Estimating OSA Endotypes from the
Oxyhemoglobin Saturation Signal in Patients Dosed with AD109 for 1 Month
– Exploratory Trial on the Impact of Investigational Combination AD113 on OSA Severity and Blood Pressure in Hypertensive Patients
CAMBRIDGE, Mass. September 6, 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 a post-hoc analysis of data from the MARIPOSA Phase 2b trial, an efficacy, safety and dose-finding study for AD109 (aroxybutynin/atomoxetine) of one-month duration, will be featured at a poster presentation at the European Respiratory Society’s (ERS) International Congress 2023 in Milan, Italy. A second poster will also be presented on a small exploratory, proof-of-concept trial for another potential compound, AD113 (atomoxetine/mineralocorticoid receptor antagonist), exploring OSA severity and blood pressure in hypertensive patients.
“ERS 2023 is an opportunity to share the latest data on our investigational oral treatments for obstructive sleep apnea with respiratory experts from around the globe,” said Larry Miller, MD, Chief Executive Officer of Apnimed. “We are excited to be on the forefront of moving the science forward for potential pharmacologic options for OSA to support the millions of people around the world who are unable or unwilling to use currently available treatments.”
Session: 145 – Basic and clinical science in sleep breathing disorders: a bidirectional relationship
Time: Sunday, September 10, 12:30-14:00 CEST
Location: Allianz MiCo, PS-6 in poster area
Presenter: Luigi Taranto Montemurro, MD, Chief Scientific Officer, Apnimed
Session: 355 – From basic to translational sleep breathing disorders
Time: Monday, September 11, 16:00- 17:30 CEST
Location: Allianz MiCo, PS-5 in poster area
Presenter: Ludovico Messineo, MD, PhD, Associate Professor ASN, Harvard Medical School
AD109 has the potential to be the first oral pharmacologic that both treats the underlying cause of OSA, airway obstruction at night, and improves daytime consequences of OSA, such as fatigue. It is a potential 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.
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