Apnimed Announces Dosing of First Patient in Phase 2 MARIPOSA Confirmatory Trial of AD109, a Potential Nighttime Oral Treatment for Obstructive Sleep Apnea (OSA)

- Study to Inform Phase 3 Program Design of AD109 and Advance Program for AD504

- Topline Results Expected Mid-2022

Apnimed, a clinical-stage pharmaceutical company focused on developing oral pharmacologic treatments to address obstructive sleep apnea (OSA) and related disorders, today announced the dosing of the first patient in the Phase 2b MARIPOSA study of AD109, the company’s lead investigational oral medication for the treatment of OSA. The study is designed to be informative for the upcoming AD109 Phase 3 program. MARIPOSA also incorporates a sub-study of AD504, a second investigational oral medication being developed by Apnimed as a potential treatment for OSA.

“There are no approved drugs for the more than 25 million people in the U.S. who have OSA, a common and serious sleep disorder in which breathing is repeatedly interrupted during sleep and that can have life-threatening consequences,” said Larry Miller, M.D., Chief Executive Officer of Apnimed. “The vast majority of diagnosed patients are prescribed positive airway pressure devices (for example, CPAP) but fewer than half are compliant long-term, leaving them at risk. With the MARIPOSA study underway, we are one step closer to bringing patients a potential new oral treatment option for OSA.”

About MARIPOSA

MARIPOSA (clinicaltrials.gov identifier NCT05071612) is a randomized, double-blind, placebo-controlled, parallel-arm, dose-finding one-month study designed to inform the Phase 3 dose for AD109 and advance dose-finding for AD504 in participants (n=280) with mild, moderate, and severe OSA. Patients will be randomized to parallel treatment arms comparing two doses of AD109, two doses of AD504, atomoxetine alone, and placebo. The study’s primary endpoint measures the change in Apnea Hypopnea Index (AHI) over one month for AD109 versus placebo. Other endpoints include the change in AHI over one month for AD504, hypoxic burden (HB), a recently developed measure of the total amount of respiratory event-related hypoxemia, as well as several symptom scales, including the Patient-Reported Outcome Measurement Information System (PROMIS). MARIPOSA is one of the largest clinical trials ever planned for a drug candidate that treats the underlying cause of OSA. Interested volunteers may obtain more information about the trial at MARIPOSAstudy.com.

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 AD504

An investigational, oral pharmacologic combination dosed once daily at bedtime, AD504 may be beneficial for OSA patients who also experience difficulty falling or staying asleep. AD504 is Apnimed’s second core program and is a combination of a selective norepinephrine reuptake inhibitor, atomoxetine, and trazodone. Inclusion of AD504 in the MARIPOSA study is intended to advance the AD504 clinical trial program. Apnimed is developing a proprietary formulation of this combination drug that will be evaluated in upcoming studies.

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 will potentially benefit from treatment with a safe and effective oral medication. Apnimed’s lead development program targets the neurologic control of upper airway muscles to maintain an open airway during sleep. The drug is delivered as a convenient once-daily pill at bedtime. Based in Cambridge, Massachusetts, 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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