New Data Underscore the Need for New OSA Treatments That Go Beyond Weight Loss to Address the Neuromuscular Root Cause of the DiseaseOral Presentations include Rationale and Design of SynAIRgy Phase 3 Study for AD109, a Potential Nighttime Oral Drug Treatment for OSA“Shining a Light on Living with Sleep Apnea” Symposium Features Premiere Sneak Preview of “Out of Breath” Film Featuring Struggles of Living with OSA, Followed by Panel Discussion CAMBRIDGE, Mass., May 23, 2024 (GLOBE NEWSWIRE) -- Apnimed, Inc., a clinical-stage pharmaceutical company focused on discovery, development and commercialization of novel oral therapies for the treatment of obstructive sleep apnea (OSA) and other sleep disorders, announced a series of five data presentations and a dinner symposium at the SLEEP 2024 annual meeting. Presentations include an epidemiologic study of the prevalence of obesity in OSA, which demonstrates that the majority of people with OSA are not obese. OSA is estimated to affect more than 50 million in the United States, though underdiagnosis continues to be a serious problem. “Apnimed is making significant contributions toward understanding the characteristics of people with OSA and the impact symptoms of OSA have on those who are not being treated. The data being presented at SLEEP 2024 reaffirm that this market has significant unmet needs,” said Larry Miller, MD, CEO of Apnimed. “AD109, our novel oral nighttime drug for OSA, currently in Phase 3 clinical development, has the potential to help patients across a broad spectrum of OSA severity and body mass index by addressing the neuromuscular root cause of OSA. Because there are no FDA approved products that specifically address the neuromuscular causes of OSA, the door is open for an oral therapy that can meet the needs of a broad range of OSA patients.” Additional presentations related to Apnimed’s pipeline of potential OSA treatments include both an oral and a poster discussion concerning the study design and rationale of SynAIRgy, the second Phase 3 registrational study for AD109, and data from the VicTor Study, a Phase 2 crossover study that evaluated an oral combination drug related to Apnimed’s pipeline development candidate AD817. SLEEP, the premier clinical and scientific sleep conference, is a joint meeting of the American Academy of Sleep Medicine (APSS) and the Sleep Research Society. SLEEP 2024, the 38th annual meeting of the APSS, will be held at the George R. Brown Convention Center in Houston from June 1-5. Apnimed SLEEP 2024 Presentation Details: POSTER:P-09, #147Prevalence of Obesity in Obstructive Sleep Apnea within a Large Community-based Cohort of Middled-aged/Older AdultsTime: Monday, June 3, 10:00-10:45 AM CTLocation:George R. Brown Convention Center, Hall A3Presenter:Neda Esmaeili, PhD, Brigham and Women's Hospital POSTER:P-08, #133Fatigue Negatively Impacts the Lives of Individuals Living with OSA: A Closer Look with Patient Reported Outcomes (PRO) MeasuresTime:Monday, June 3, 10:00-10:45 AM CTLocation:George R. Brown Convention Center, Hall A3Presenter:Helene Emsellem, MD, Director, The Center for Sleep & Wake Disorders & Sleep Health Institute SYMPOSIUM:Shining a Light on Living with Sleep ApneaSneak Preview:“Out of Breath,” an independent film about living with OSA followed by a panel discussion with the film’s director and starsTime:Tuesday, June 4, 6:15-8:30PM CTLocation:Marriott Marquis, Houston, Salon A-BRegister:https://bit.ly/3y2gbqe ORAL:O-26Aroxybutynin and Atomoxetine for the Treatment of OSA: Rationale and Design of theSynAIRgy Phase 3 RCTSession:Updates on Non-PAP Therapy for Sleep-Related Breathing DisordersTime: Wednesday, June 5, 2:15-2:30PM CTLocation:George R. Brown Convention Center, Room 362Presenter:Patrick Strollo, Jr., MD, Professor of Medicine and Clinical and Translational Science,Vice Chair of Medicine for Veterans Affairs, University of Pittsburgh School of Medicine POSTER:P-41, #274Aroxybutynin and Atomoxetine for the Treatment of OSA: Rationale and Design of the SynAIRgy Phase 3 RCTTime: Wednesday, June 5, 11:00-11:45 AM CTLocation: George R. Brown Convention Center, Hall A3Presenter:Patrick Strollo, Jr., MD, Professor of Medicine and Clinical and Translational Science, Vice Chair of Medicine for Veterans Affairs, University of Pittsburgh School of Medicine ORAL:O-26The Effect of Viloxazine and Trazodone in Obstructive Sleep Apnea Patients: A Randomized, Placebo-controlled, Crossover StudySession:Updates on Non-PAP Therapy for Sleep-Related Breathing DisordersTime: Wednesday, June 5, 2:30-2:45PM CTLocation:George R. Brown Convention Center, Room 362Presenter:Atqiya Aishah, PhD, Brigham and Women’s Hospital About the SynAIRgy StudyThe SynAIRgy Study (clinicaltrials.gov identifier NCT05813275) is a randomized, double blind, placebo-controlled, parallel-arm 6-month study of a fixed dose combination of aroxybutynin/atomoxetine (AD109) in adult participants with OSA who are intolerant of, or currently refuse, positive airway pressure (PAP) therapy. The SynAIRgy Study examines the use of AD109 in a range of OSA patients across all types of OSA from mild to severe and ranges of body mass index (BMI) from normal to obese. Participants (n=640) will be randomized 1:1 to either AD109 or placebo. The primary endpoint is designed to evaluate reduction of airway obstructions (AHI4) for AD109 vs. placebo. A key secondary endpoint is evaluating OSA symptoms based on the PROMIS-Fatigue scale for AD109 vs. placebo. Other standard objective and subjective metrics of OSA will also be evaluated. The trial also includes an additional cohort of up to 100 participants concomitantly on AD109 and a stable dose of a GLP-1 agonist for weight loss. The trial will include up to 65 enrolling centers across the US and Canada. SynAIRgy is continuing enrollment. Interested participants may check their eligibility at www.sleepapneatrial.com. Topline Phase 3 data for both AD109 registrational trials, LunAIRo and SynAIRgy, are expected in mid-2025. About AD109AD109 has the potential to be the first oral drug that could both treat the underlying nighttime airway obstruction and hypoxia that characterize OSA, as well as improve the daytime consequences of OSA, such as fatigue. It is a potential first-in-class, novel, investigational combination dosed once daily at bedtime and is designed to treat OSA patients across a broad spectrum of disease severity. AD109 combines Apnimed’s novel selective antimuscarinic (aroxybutynin) with a selective norepinephrine reuptake inhibitor (atomoxetine) in a fixed dose combination. AD109 targets key neurological pathways in OSA that activate upper airway dilator muscles to maintain an open airway during sleep. AD109 has the potential to become a safe, effective, and convenient treatment for OSA, addressing some of the key limitations of approved treatments that are often poorly tolerated (e.g., CPAP and oral devices) and/or invasive (e.g., surgery or implanted devices). AD109 has been granted Fast Track designation by the FDA and is currently in Phase 3 clinical trials. About the VicTor StudyThe VicTor Study (clinicaltrials.gov identifier NCT05793684) is a Phase 2 randomized double-blind placebo-controlled multiple-dose 3-period crossover study comparing a fixed dose combination of viloxazine/trazodone to viloxazine alone and to placebo in obstructive sleep apnea. About Obstructive Sleep Apnea
Obstructive sleep apnea is one of the most common and serious sleep disorders. It is estimated to affect more than 50 million and as many as 80 million people in the United States, though underdiagnosis continues to be a serious problem and the number of affected Americans may be far greater. OSA impacts people across the spectrum of sex, age, ethnicity and BMI ranges from normal to obese. OSA is characterized by partial or complete upper airway collapse that occurs during sleep, which can cause dramatic reductions in overnight oxygen levels and often leads to poor sleep, and in the long term, has been shown to increase the risk of hypertension, diabetes, cardiovascular disease, and stroke. Additionally, OSA can impair work productivity, reduce daytime functional abilities, and lower quality of life. Sleep-related neuromuscular dysfunction is the key mechanism that causes a reduction in neuromuscular tone of the upper airway during sleep. 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 or undertreated and at risk. Some OSA patients are overweight or obese, and sustained weight loss can reduce the severity of airway collapse and some symptoms. However, even substantial weight loss may not fully address the symptoms of OSA or reduce the need for treatments that help maintain an open airway during sleep, and if patients regain weight, OSA and its symptoms tend to return. About ApnimedApnimed 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, AD109, 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 other sleep disorders. Apnimed has a pipeline of novel, oral pharmacologic programs including several that are part of our Joint Venture with Shionogi & Co., Ltd. called Shionogi-Apnimed Sleep Science, LLC. Learn more at apnimed.com or follow us on X and LinkedIn. Media Contact:Amanda BreedingScient PRamanda@scientpr.com Mikala Whitaker Spectrum Sciencemwhitaker@spectrumscience.com Investor Contact:Brian Ritchie LifeSci Advisorsbritchie@lifesciadvisors.com
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