New Data Show Clinically Meaningful Improvements for Investigational Oral Pharmacologic Treatment AD504 in People With Obstructive Sleep Apnea

CAMBRIDGE, Mass.–()–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 a proof-of-concept study exploring two potential oral therapeutic candidates for the treatment of patients with OSA, AD504 (atomoxetine + trazodone) and AD182, will be featured in an oral presentation at SLEEP 2022 in Charlotte, NC, on Monday, June 6. SLEEP 2022 is the 36th annual meeting of the Associated Professional Sleep Societies (APSS), a joint venture of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society (SRS).

“This study reinforces the potential of AD504 as a follow on to our lead product AD109,” said Larry Miller, M.D., Chief Executive Officer of Apnimed. “We believe that exploring multiple oral drug combinations and subpopulations could uncover powerful new treatment options for people with OSA. We’re pleased that these data continue to reinforce the study of AD504, which is currently included alongside our lead candidate AD109 in our Phase 2b MARIPOSA study.”

Presentation Details:

 

Title:

Effects of Atomoxetine plus a Hypnotic on Obstructive Sleep Apnea (OSA) Severity in Patients with a Moderately Collapsible Pharyngeal Airway

 

Abstract:

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Oral Presentation:

Monday, June 6, 2022 at 11:30-11:45am ET

 

Session:

O-03: Obstructive Sleep Apnea, 11:30am-12:30pm ET

 

Location:

Richardson Ballroom CD, Charlotte Convention Center, Charlotte, NC

 

Presenter:

Bruce Corser, MD, FAASM

Study APX-001 Data Summary: A Phase 2 Clinical Trial Exploring AD504 and AD182 in OSA Patients (clinicaltrials.gov identifier NCT04645524)

This was a proof-of-concept, randomized, controlled, double-blind, single-dose, three-period crossover study of 15 patients who met eligibility criteria. Each patient received one night of AD504 (atomoxetine and trazodone), one night of AD182 (atomoxetine and an orexin antagonist), and one night of placebo. Doses were given immediately prior to bedtime.

AD504 showed a significant reduction of the Apnea Hypopnea Index (AHI) (from 18.2 [11.8 to 31.3] on placebo to 7.4 [5.4 to 16.1] events/h on AD504, p=0.024 and Hypoxic Burden (HB) from 46.3 [25.1 to 88.3] on placebo to 18.7 [14.9 to 43.5], p=0.003 on AD504. AD182 also demonstrated a trend towards reduction in HB relative to placebo but the effects were smaller than what was seen for AD504. Both combination drugs also demonstrated a favorable safety profile.

About AD504

An investigational, oral pharmacologic combination dosed once daily at bedtime, AD504 may be beneficial for OSA patients who also experience sleep disturbance. AD504 is Apnimed’s second core program and is a combination of atomoxetine and trazodone. Further Phase 2 development of AD504 has been incorporated in the MARIPOSA study (a large Phase 2 study assessing both AD109 and AD504, clinicaltrials.gov identifier NCT05071612). Apnimed is developing proprietary formulations of the AD504 combination.

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 35 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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