Apnimed Announces Positive Phase 2 Data (Study APC-004) Demonstrating Improvement in Measures of Obstructive Sleep Apnea and a Dose-Response with AD109, an Oral Pharmacologic Investigational Treatment for the Disease

- Primary and key secondary endpoints showed statistically significant and clinically meaningful benefit in patients with mild to moderate OSA

- AD109 was safe and well-tolerated at both doses studied

- Data from a second Phase 2 study (APC-003) in patients with more severe disease also released today

Apnimed, a clinical-stage pharmaceutical company focused on developing oral pharmacologic treatments to address obstructive sleep apnea (OSA) and related disorders, today announced positive data across multiple endpoints from its Phase 2 randomized, double-blind, placebo-controlled, crossover clinical trial (Study APC-004) evaluating the efficacy and safety of AD109 as a treatment for patients with mild to moderate OSA.

Patients treated with both the high and low doses of AD109 had a large, statistically significant, and clinically meaningful difference from placebo after a single dose in their Hypoxic Burden (HB), which is a measure of the total amount of respiratory event-related hypoxemia, or low blood oxygen during sleep, and was the study’s primary endpoint. The Apnea-Hypopnea Index (AHI), was a secondary endpoint indicating the number of apnea (cessation of breathing) and hypopnea (shallow breathing) events per hour of sleep, and demonstrated a similar reduction on both high and low doses of AD109. Treatment with AD109 was safe and well tolerated at both doses studied.

“We are extremely encouraged by these results which continue to reinforce the potential of AD109 to have a clinically meaningful benefit for patients with mild to moderate OSA,” said Larry Miller, M.D., Chief Executive Officer of Apnimed. “Both doses studied in this clinical trial led to statistically significant improvements across multiple measures of disease severity and demonstrated clear evidence of a dose-response.”

Dr. Miller continued by saying, “These data, combined with that of our Phase 2 study, APC-003, in a patient population with more severe disease, support the further advancement of AD109 as the first pharmacologic treatment for patients with a range of OSA severity. We plan to initiate a third Phase 2 confirmatory study, called MARIPOSA, which is slated to start later this year. MARIPOSA will help us finalize the trial design and the doses for our Phase 3 program, which we anticipate initiating at the end of 2022.”

Apnimed also issued a press release today showcasing results from a second Phase 2 study, APC-003, exploring the safety and efficacy of AD109 in patients with mild to severe OSA. For more information on that announcement, click here.

Study APC-004 Data Summary: A Phase 2 Clinical Trial in Patients with Mild to Moderate OSA (NCT04631107)

This was a randomized, double-blind, placebo-controlled, crossover design 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 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.

“Many OSA patients go untreated because the currently available treatment options can be uncomfortable and cumbersome, leaving patients at risk for potentially debilitating adverse health outcomes,” said Russell Rosenberg, M.D., the principal investigator on the study from Neurotrials Research (Atlanta, GA). “These AD109 data are the first evidence of a clinically meaningful benefit from a pharmacologic approach to treating OSA, which if successful could be a revolution in the way we treat this highly burdensome disease which can have a major impact on the health of afflicted individuals.”

About AD109

AD109 is Apnimed’s first-in-class, investigational, oral pharmacologic combination dosed once daily at bedtime, designed to treat OSA patients across a broad spectrum of disease severity. AD109 targets key neurological pathways in OSA, reducing 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) - to activate the upper airway dilator muscles and maintain an open airway during sleep. The investigational drug combination is designed to be safe, effective, and convenient, addressing the key limitations of the current standard of care treatments, and 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 leading to OSA. In patients with OSA, sleep onset leads to a reduction in neuromuscular control of the upper airway and 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 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 at bedtime. 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

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