– Positive Data on Investigational Oral Pharmacologic Treatment AD109 Showed Statistically Significant and Clinically Meaningful Benefits for Patients with Obstructive Sleep Apnea

CAMBRIDGE, Mass. March 9, 2022 – Apnimed, a clinical-stage pharmaceutical company focused on developing oral pharmacologic treatments to address obstructive sleep apnea (OSA) and related disorders, today announced that data from its Phase 2 study APC-004 will be featured in an oral presentation at World Sleep 2022 in Rome, Italy on Monday, March 14. Top line data from this study were highlighted in a press release issued by Apnimed in October 2021.

“These data continue to reinforce the potential benefit of AD109 in people with mild to moderate OSA, and we’re pleased to present them for the first time at a major medical congress,” said Larry Miller, M.D., Chief Executive Officer of Apnimed. “Being able to advance a pharmacologic approach to treating OSA is critical for the millions of people worldwide who are looking for alternatives to currently available treatment options that can be uncomfortable or cumbersome. We look forward to advancing our AD109 program in the ongoing confirmatory Phase 2 study called MARIPOSA, with results expected later this year.”

“The APC-004 study data showed a statistically significant and clinically meaningful benefit for AD109,” said Russell Rosenberg, Ph.D., D.ABSM, Founder and Director of the Atlanta School of Sleep Medicine and Technology and the principal investigator for the study from NeuroTrials Research, Inc. (Atlanta, GA). “These data highlight the potential benefit of a pharmacologic approach to addressing OSA, a prevalent and life-threatening disease. I’m excited to share the findings with my colleagues in Rome and look forward to continued study of AD109.”

Title: Combination of atomoxetine with the novel antimuscarinic aroxybutynin improves mild to moderate OSA

Abstract: ABS-WS-2022-00357

Oral Presentation: Monday, March 14, 2022, at 4:45–6:15pm CET

Location: Room 31, Roma Convention Center La Nuvola

Presenter: Russell Rosenberg, Ph.D., D.ABSM


About Study APC-004

Study APC-004 (clinicaltrials.gov identifier NCT04631107) was a randomized, double-blind, placebo-controlled, crossover design Phase 2 study of 32 patients who met eligibility criteria for mild to moderate OSA. Each patient received low-dose AD109, high-dose AD109, and placebo at bedtime across three overnight periods in randomized order.

Patients treated with both the high and low doses of AD109 had a large, statistically significant, and clinically meaningful difference from placebo in their Hypoxic Burden (HB), which was the study’s primary endpoint. The median HB for participants on placebo was significantly higher than for patients on the high dose (p<0.001) and on the low dose (p<0.01). HB measures the total amount of respiratory event-related hypoxemia during sleep and a growing body of evidence supports HB as the most meaningful predictor of adverse cardiovascular outcomes in patients with OSA.

Additionally, the data showed a statistically significant and clinically meaningful median reduction in AHI [Median AHI of 13.2 events/h on placebo reduced to a median of 5.5 events/h on the high dose (p<0.001) and to a median of 7.8 on the low dose (p<0.05)]. AHI indicates the number of apnea and hypopnea events per hour of sleep. AD109 also demonstrated a highly favorable safety profile at both doses studied.

About AD109

AD109 is Apnimed’s potential first-in-class, investigational, oral pharmacologic combination dosed once daily at bedtime. It is designed to treat OSA patients across a broad spectrum of disease severity. AD109 is designed to target key neurological pathways in OSA that cause pathological upper airway closure during sleep. AD109 combines a selective norepinephrine reuptake inhibitor (atomoxetine) with Apnimed’s novel new chemical entity (NCE) – a selective antimuscarinic (aroxybutynin) – intended to activate the upper airway dilator muscles and maintain an open airway during sleep. The investigational drug combination has the potential to be a safe, effective, and convenient treatment for OSA, and may address some of the key limitations of the current standard of care treatments. It is currently in Phase 2 clinical trials.

About Obstructive Sleep Apnea

Obstructive Sleep Apnea (OSA) is one of the most common and serious sleep disorders and is estimated to affect more than 25 million Americans, though underdiagnosis continues to be a serious problem. OSA is characterized by partial or complete upper airway closure that occurs during sleep, which 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 functional ability, 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.

About Apnimed

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 Twitter and LinkedIn.


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