AD128 is a drug combination under development by Apnimed for the treatment of Obstructive Sleep Apnea
Phase 2 data from Apnimed’s most advanced drug candidate for Obstructive Sleep Apnea, AD109, anticipated in 2ndquarter of this year

CAMBRIDGE, Mass. May 17, 2021 – Apnimed, a clinical-stage company focused on advancing pharmacologic treatments for sleep apnea and related disorders, announced today that researchers from Istituto Auxologico Italiano and Brigham and Women’s Hospital presented data on the company’s investigational treatment for obstructive sleep apnea, AD128, at the American Thoracic Society (ATS) Meeting, taking place from May 14-19, 2021. The data presented confirm and expand upon prior research by Apnimed and its affiliates demonstrating the potential of pharmacotherapy to treat obstructive sleep apnea (OSA).

“These data reinforce that combining a norepinephrine reuptake inhibitor and a selective antimuscarinic is a promising new oral treatment approach for patients with OSA,” said Larry Miller, MD, Chief Executive Officer of Apnimed. “As we’re building a pipeline of treatments to address OSA and related disorders, we continue to evaluate different pharmacologic options to address the underlying biology of these life-altering and life-threatening sleep disorders. We also look forward to data from our most advanced program, AD109, in the coming months.”

The data were presented in an oral mini-symposium held May 17, 2021, 3:30- 5:00 PM EDT.  In this study presented at ATS, researchers evaluated the effect on OSA of reboxetine plus oxybutynin. The administration of reboxetine plus oxybutynin before bedtime greatly decreased OSA severity and increased next-day vigilance (assessed with a psychomotor vigilance test, PVT) after 1-week of therapy. These results confirm and expand upon previous findings that the combination of noradrenergic and antimuscarinic agents is likely to be effective in OSA. Further, the data highlight novel possibilities for pharmacotherapy to treat OSA.

“Researchers have been exploring the potential of drug treatment options for the treatment of sleep apnea for years. We believe that these data reinforce the potential of pharmacotherapy in treating OSA,” said Elisa Perger, MD, principal investigator at Istituto Auxologico Italiano IRCCS in Milan, Italy. “Today patients are restricted to mechanical or surgical treatments or pharmacologic therapies that only address the symptoms. In our study, the administration of reboxetine plus oxybutynin before bedtime greatly decreased OSA severity over one week, demonstrating the ability of an oral drug which addresses the underlying cause of the disease.”

About Apnimed’s Investigational Programs:

Apnimed’s lead product candidate, AD109, targets the neurologic control and facilitates the activation of the upper airway dilator muscles to maintain an open airway during sleep. AD109 is a first-in-class, oral pharmaceutical combination dosed once daily at bedtime, designed to treat OSA patients across a broad spectrum of disease severity. AD109 combines a selective norepinephrine reuptake inhibitor (NRI) with a low dose of the company’s novel new chemical entity (NCE) selective antimuscarinic. The investigational drug is designed to be safe, effective, and convenient, addressing the key limitations of the current standard of care treatments.

AD128 is an oral pharmaceutical combination under development that includes reboxetine (a norepinephrine reuptake inhibitor similar to atomoxetine, a component of AD109) plus oxybutynin (a selective antimuscarinic).

About Obstructive Sleep Apnea

Obstructive Sleep Apnea (OSA) is one of the most common and serious sleep disorders and affects approximately six percent of women and 13 percent of men in the U.S., totaling more than 25 million Americans. OSA is characterized by partial or complete upper airway occlusion that occurs during sleep which may lead to poor sleep, and in the long term, hypertension, diabetes, cardiovascular disease, strokes, and early mortality. OSA is also a major cause of motor vehicle accidents and workplace injuries. Over 80 percent of diagnosed patients are prescribed positive pressure devices such as CPAP, but only 30-40 percent are compliant long-term, leaving a significant population untreated and at risk. Apnimed expects its pharmacologic therapies to transform the treatment of this serious sleep disorder.

About Apnimed

Apnimed is a clinical-stage company working to transform the treatment of sleep apnea based on a simple idea – patients will benefit from safe and effective oral drug treatment. Based in Cambridge, Mass., the company is developing a portfolio of novel pharmacologic therapies for sleep apnea and related disorders. To learn more visit or follow the company on LinkedIn and Twitter.

Media Contact:
Courtney Heath

Investor Contact:
Elizabeth Woo
Kendall IR