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Yahoo
19-05-2025
- Health
- Yahoo
Apnimed Announces Positive Topline Results in the First Landmark Phase 3 Clinical Trial of AD109, an Investigational Once-daily Oral Pill for Obstructive Sleep Apnea
AD109 met the primary endpoint, mean change in apnea-hypopnea index (AHI, p=0.001) at 26 weeks, across a broad range of people with mild, moderate and severe obstructive sleep apnea Study participants treated with AD109 achieved a mean reduction in AHI of 55.6% from baseline and achieved significantly improved oxygenation and reduced disease severity AD109 is a first-in-class, anti-apneic neuromuscular modulator which targets the root cause of OSA by increasing upper airway muscle tone during sleep Apnimed expects topline results in Q3'25 from its second Phase 3 clinical trial, LunAIRo, and plans to submit an NDA to the U.S. FDA for AD109 by early 2026 CAMBRIDGE, Mass., May 19, 2025 /PRNewswire/ -- Apnimed, Inc., a pharmaceutical company building the industry-leading portfolio of first-in-class oral drug candidates that address the root causes of obstructive sleep apnea (OSA) and other sleep-related breathing diseases, today announced positive topline results from its pivotal Phase 3 SynAIRgy clinical trial evaluating the efficacy and safety of Apnimed's lead candidate AD109 (aroxybutynin 2.5mg/atomoxetine 75mg) in adults living with mild, moderate and severe OSA, and across all weight classes. The SynAIRgy trial met its primary endpoint: mean change from baseline in the apnea-hypopnea index (AHI) at 26 weeks compared to placebo (p=0.001). The topline results for the primary and multiple secondary endpoints were similar to the results observed in the previous 4-week MARIPOSA Phase 2b clinical trial. AD109 was generally well-tolerated, and the most common adverse events were consistent with earlier AD109 clinical trials. No serious adverse events related to AD109 were reported in the SynAIRgy trial. An estimated 80 million people in the United States and one billion people worldwide are living with OSA. OSA is caused by two overlapping mechanisms: neuromuscular dysfunction during sleep and predisposing anatomic abnormalities. AD109 is designed to target the neurobiology of the hypoglossal motor nucleus by increasing signals to the upper airway muscles during sleep, leading to the reduction or prevention of upper airway collapse. "Today is a landmark moment for Apnimed and for millions living with OSA who have long struggled with limited treatment options," said Larry Miller, MD, Chief Executive Officer of Apnimed. "The positive results from our Phase 3 SynAIRgy trial bring us closer to realizing our vision of offering a simple, safe, and effective oral drug — one that is grounded in science, driven by unmet need, and centered on people with OSA. We believe these results represent the dawn of a new era in the OSA treatment paradigm. We are deeply grateful to the patients, investigators, and clinical teams whose partnership and commitment made this achievement possible. Importantly, these results increase our confidence in the expected outcome of the second Phase 3 clinical trial, LunAIRo, with topline results expected in Q3'25." Additional Efficacy ResultsIn addition to meeting the primary endpoint, AD109 also demonstrated improvements in other secondary and exploratory endpoints, including: Meaningful improvements in oxygenation as assessed by hypoxic burden (p<0.0001) and oxygen desaturation index (p=0.001) 51.2% of participants treated with AD109 showed a reduction in OSA disease severity category 22.3% of participants treated with AD109 achieved complete OSA disease control (defined as AHI <5 events/hour) "These Phase 3 topline results are highly encouraging and represent the potential for a much-needed innovation in the treatment of OSA," said Patrick Strollo, Jr., MD, study chair of the SynAIRgy clinical trial and Vice Chair of Medicine for Veteran's Affairs at the University of Pittsburgh School of Medicine. "For too long, progress in OSA has been limited, leaving many people with OSA without sustainable treatment options. The results from SynAIRgy suggest that if approved, AD109 could offer a compelling new treatment option — a novel oral drug that targets the neuromuscular root cause of airway obstruction in sleep apnea and holds promise for transforming care for a broad range of patients." "OSA should be considered a top public health priority: it is a serious, common, chronic disease that affects a wide range of people, impacting both males and females of all age groups, ethnicities, and weight classes, including those with or without obesity," said Monica Mallampalli, PhD, President and CEO of the Alliance of Sleep Apnea Partners. "There is a vast need for new treatment options. We welcome innovations like this, which are long overdue for our patient community. The SynAIRgy results offer people hope that an oral therapy is on the horizon that could make it easier for them to manage their OSA and reclaim their lives." Advancing AD109Apnimed plans to submit a New Drug Application (NDA) for AD109 to the U.S. Food and Drug Administration (FDA) by early 2026 for regulatory review. The full data for SynAIRgy will be presented at a medical congress later this year and published in a peer-reviewed scientific journal. Apnimed also anticipates the availability of topline data in Q3 2025 from the second Phase 3 LunAIRo trial, a one-year study of AD109 in adults with OSA. About the SynAIRgy StudyThe SynAIRgy study (NCT05813275) was a randomized, double blind, placebo-controlled, parallel-arm six-month clinical trial of AD109, a fixed dose combination of aroxybutynin 2.5mg/atomoxetine 75mg, in participants with OSA who are intolerant of or currently refuse continuous positive airway pressure (CPAP) therapy. The trial enrolled 646 adult participants from 73 centers in the US and Canada. Participants were randomized 1:1 to either AD109 or placebo and instructed to take their assigned treatment once-daily before bedtime. SynAIRgy is the largest Phase 3 clinical trial of a medication to treat OSA. Enrolled participants in SynAIRgy were representative of the real-world patient population, including the diverse demographic composition of the United States and the typical profiles seen in a sleep clinic population. Participants included 49.1% females, multiple racial groups, and varied weight classes spanning healthy weight, overweight, and with obesity. Participants were distributed across OSA severity levels, including mild (34.4%), moderate (42.4%), and severe (23.2%). Participants had symptoms reflective of the OSA patient experience. About AD109AD109 is designed to be the first pharmacological treatment to improve oxygenation during sleep by directly addressing the neuromuscular root cause of upper airway collapse in people with obstructive sleep apnea. It is a first-in-class combination of aroxybutynin, a novel antimuscarinic, and atomoxetine, a selective norepinephrine reuptake inhibitor (NRI). Their combined pharmacological synergy targets the underlying neuromuscular cause of OSA. AD109 is a once-daily pill taken at bedtime that is designed to lower the complexity of intervention and may help more people benefit from effective, restorative sleep. In a disease characterized by complex and invasive treatment options, AD109 may be a simple solution to help improve oxygenation and health wellbeing for people living with OSA. About Obstructive Sleep ApneaObstructive sleep apnea (OSA) is a serious, chronic sleep-related breathing disease in which the upper airway repeatedly collapses during sleep, leading to intermittent oxygen deprivation. It is caused by two overlapping mechanisms: neuromuscular dysfunction during sleep and predisposing anatomic abnormalities. OSA affects individuals across all walks of life, impacting both males and females of all age groups, ethnicities, and weight classes, including those with or without obesity. An estimated 80 million people in the United States and one billion people worldwide suffer from OSA. Up to 80% of people living with OSA are undiagnosed and therefore untreated. An individual with OSA can experience hundreds of sleep apnea events in a single night, each one reducing the blood oxygen levels and negatively impacting cellular functions vital to normal health and function. Failure to effectively treat OSA increases the risk of serious long-term health consequences, including cardiovascular disease, neurocognitive impairment, metabolic dysfunction, and early mortality. Yet, the majority of those diagnosed with OSA refuse, abandon, or underutilize treatment. Currently, no available pharmacological treatments directly address the underlying neuromuscular dysfunction that is present in OSA. About ApnimedApnimed is a privately held clinical-stage pharmaceutical company dedicated to transforming the treatment landscape for sleep-related breathing diseases. We believe the introduction of simple, once-nightly oral drugs has the potential to dramatically expand diagnosis and the reach of treatment for people with OSA. OSA, like other common chronic diseases such as diabetes or hypertension, would benefit from having multiple drugs with differing mechanisms to more fully address the heterogeneity of disease pathophysiology. Apnimed envisions a new era where novel oral therapies simplify intervention, expand the reach of diagnosis and treatment, and help more people get the oxygen and restorative sleep needed to thrive. Based in Cambridge, Mass., Apnimed is advancing a robust pipeline of oral pharmaceutical product candidates designed to improve oxygenation in individuals living with OSA and other sleep-related breathing disorders. Our lead candidate, AD109, could become the catalyst for a new oral treatment paradigm for OSA that has been historically limited to cumbersome devices or invasive surgeries. AD109 is currently in Phase 3 clinical trials for the treatment of mild, moderate and severe OSA. Apnimed is also developing several therapies as part of its joint venture with Shionogi & Co., Ltd., Shionogi-Apnimed Sleep Science. Learn more at or follow us on X and LinkedIn. Media Contact: media@ Investor Contact:ir@ View original content to download multimedia: SOURCE Apnimed, Inc. Sign in to access your portfolio
Associated Press
25-03-2025
- Health
- Associated Press
Apnimed to Host Virtual Investor Event Highlighting the Potential for AD109 as a Novel Pharmacotherapy for Obstructive Sleep Apnea on April 11, 2025
CAMBRIDGE, Mass., March 25, 2025 /PRNewswire/ -- Apnimed, Inc., a pharmaceutical company focused on discovery, development, and commercialization of first-in-class oral therapies that address the neuromuscular dysfunction of obstructive sleep apnea (OSA) and other sleep-related breathing diseases, today announced that it will host a virtual investor event on Friday, April 11, 2025 at 12:00 PM ET. To register, click here. The event will feature leading experts in sleep medicine, Douglas Kirsch, MD, FAAN, FAASM (Wake Forest University), and Nathaniel Watson, MD, MSc, FAAN, FAASM (University of Washington), who will provide an in-depth analysis of the unmet medical need in OSA and the shifting treatment paradigm. In addition, Apnimed will unveil new analyses exploring the potential impact of pharmacotherapies on the OSA treatment landscape, with a focus on AD109, Apnimed's investigational oral tablet designed to target the neuromuscular root cause of upper airway collapse in people with OSA. Apnimed's leadership team will also provide an update on its ongoing Phase 3 SynAIRgy and LunAIRo trials, and a preview of Apnimed's go-to-market strategy to unlock the blockbuster potential of AD109. Top-line results from Apnimed's Phase 3 SynAIRgy and LunAIRo clinical trials are expected in the second quarter of 2025 and the third quarter of 2025, respectively. A live question and answer session will follow the presentations and KOL discussion. About Douglas Kirsch, MD, FAAN, FAASM Dr. Kirsch is the Medical Director of Atrium Health Sleep Medicine, where he maintains an active clinical sleep practice and oversees clinical sleep medicine for the multi-state hospital system. He is currently a Clinical Professor in the Department of Neurology at the Wake Forest School of Medicine and was previously on the faculty at the University of Michigan Medical School and Harvard Medical School. He was the 2018-19 President of the American Academy of Sleep Medicine and was the Program Chair for the SLEEP Meeting in 2012-14 and the Chair of AASM Sleep Medicine Trends course from 2023-5. His current interests include emerging technology in Sleep Medicine and proving the value of Sleep Medicine care. About Nathaniel Watson, MD, MSc, FAAN, FAASM Dr. Watson is currently Professor and Vice Chair of Faculty Affairs in the Department of Neurology, Co-director of the Sleep Center, and Director of the Harborview Medical Center Sleep Clinic at the University of Washington. He holds certifications with the American Board of Psychiatry and Neurology, with a Sleep Medicine subspecialty, and the American Board of Sleep Medicine. Dr. Watson is a former President of the American Academy of Sleep Medicine and the American Board of Sleep Medicine. Over the course of his career he has held multiple research grants to study sleep disturbances and published extensively for medical and lay audiences. He has led the development of guideline and consensus documents regarding monitoring and managing sleep disturbances. His research has investigated genetic aspects of sleep duration and metabolic disease, mental health, and inflammation. His current investigations include the relationship between sleep and cancer risk, the impact of artificial intelligence and consumer sleep technology on human sleep and sleep medicine, and increasing access to sleep care for Native American populations. He is a passionate advocate for sleep health, with efforts focused on promoting healthy school start times, abolishment of daylight saving time, and transportation safety. His sleep advocacy and media work has touched millions of lives. Dr. Watson studied medicine at the University of North Carolina and obtained his master of science in genetic epidemiology from the University of Washington. He completed his medical internship, neurology residency, and clinical neurophysiology fellowship at the University of Washington. He has also conducted postgraduate studies at the National Institutes of Health and the University of Colorado. About AD109 AD109 could be the first pharmacological treatment to improve oxygenation during sleep by directly addressing the underlying neuromuscular cause of upper airway collapse in people with obstructive sleep apnea. It is a first-in-class combination of aroxybutynin, a novel antimuscarinic, and atomoxetine, a selective noradrenaline reuptake inhibitor (NRI). Their combined pharmacological synergy targets the root neuromuscular cause of OSA. AD109 is a once-nightly oral pill that is designed to lower the complexity of intervention and may help more people benefit from effective, restorative sleep. In a disease characterized by complex and invasive treatment options, AD109 may be a simple solution to help improve oxygenation and health wellbeing for people living with OSA. About Obstructive Sleep Apnea Obstructive sleep apnea is a serious chronic sleep-related breathing disease where the upper airway repeatedly collapses during sleep, causing intermittent oxygen deprivation. It is caused by two overlapping mechanisms: neuromuscular dysfunction during sleep and predisposing anatomic abnormalities. The impact of OSA spans age, sex, and body type—there is no single face of the disease. Every night, greater than 54 million people in the U.S. and 1 billion people worldwide with OSA intermittently stop breathing, exposing them to serious, long-term health risks. An individual with OSA can experience hundreds of these sleep apnea events in a single night. Each sleep apnea event reduces blood oxygen levels and deprives cells of the energy they need to perform vital functions. Ultimately, failure to effectively treat OSA increases the risk of long-term health consequences and quality of life impacts, including daytime fatigue, impaired judgement, premature death, and severe and potentially life-threatening health complications, such as high blood pressure, cardiovascular disease, and type 2 diabetes. Yet, even after being diagnosed, the majority of people with OSA either refuse, abandon, or underutilize treatment. In addition, no currently available treatments address the underlying neuromuscular dysfunction present in all OSA cases. About Apnimed Apnimed is a pharmaceutical company dedicated to breathing new life into the sleep-related breathing disease treatment landscape. The company envisions a new era where novel oral therapies simplify intervention, expand the reach of diagnosis and treatment, and elevate the health and expectations of everyone in the sleep-related breathing disease community. Based in Cambridge, Mass., Apnimed is advancing a focused pipeline of oral pharmaceutical product candidates designed to help improve oxygenation for people living with obstructive sleep apnea and beyond, to other sleep-related breathing diseases, including several that are part of our joint venture with Shionogi & Co., Ltd, Shionogi Apnimed Sleep Science (SASS). Learn more at or follow us on X and LinkedIn. Media Contact:
Associated Press
11-03-2025
- Business
- Associated Press
Apnimed Appoints Kevin R. Lind as Non-Executive Chairman of the Board of Directors
– Larry Miller, CEO, to Continue Serving as Non-Independent Board Director – Phase 3 SynAIRgy and LunAIRo Clinical Trials on Track for Topline Results in 2Q2025 and 3Q2025, Respectively CAMBRIDGE, Mass., March 11, 2025 /PRNewswire/ -- Apnimed, Inc., a pharmaceutical company focused on discovering, developing, and commercializing first-in-class oral therapies for the neuromuscular dysfunction associated with obstructive sleep apnea (OSA) and other sleep-related breathing diseases, today announced the expansion of its Board of Directors with the appointment of Kevin R. Lind as non-executive Chairman of the Board. Mr. Lind brings decades of experience from the biotech and financial sectors. 'We are thrilled to welcome Kevin to Apnimed's Board,' said Larry Miller, MD, Chief Executive Officer of Apnimed. 'His proven leadership in biotechnology and corporate strategy will provide invaluable insights as we approach Phase 3 clinical trial results for AD109 and prepare for its potential commercial launch as a once-nightly oral therapy for OSA. Our team has been executing to our stated milestones and, most importantly, our ongoing Phase 3 trials are on track to report top-line results in 2Q2025 and 3Q2025, respectively.' 'Apnimed is well-positioned for growth with both its promising late-stage asset, AD109, and its synergistic partnership with Shionogi to drive long-term value,' said Mr. Lind. 'I am excited to join Apnimed at this pivotal time and look forward to contributing to the company's continued clinical and future commercial successes.' About Kevin Lind Kevin Lind recently served as Longboard Pharmaceuticals' President and Chief Executive Officer and as a member of its board from the company's inception in 2020 until Longboard was acquired by H. Lundbeck A/S in December 2024. Prior to co-founding Longboard Pharmaceuticals, Mr. Lind served as EVP and Chief Financial Officer during the turnaround of Arena Pharmaceuticals (acquired by Pfizer) from 2016 to 2020. As an executive leader at these organizations, he successfully raised over $1.1B in equity capital (including Longboard's IPO), secured valuable business development partnerships (including ~$1B in upfront payments), spun out two organizations, and was instrumental in activities resulting in the successful acquisitions of both companies for a cumulative value of ~$9.3B. At Longboard, Mr. Lind also led the initiation of a global Phase 3 program for a neurological drug candidate, bexicaserin, and innovative drug development strategies resulting in the conceptualization of a novel medical indication and securing of Breakthrough Therapy designation from the U.S. FDA. Prior to Longboard, Mr. Lind focused on healthcare investing at TPG Special Situations Partners from 2009 to 2016 and at TPG-Axon from 2006 to 2008. He served in various capacities as a healthcare investment banker at Lehman Brothers, Inc., a former global financial services firm, from 1998 to 2002 and 2004 to 2006. Mr. Lind received a B.S. from Stanford University in Biological Sciences and an MBA from UCLA Anderson School of Management. About AD109 AD109 is a once-nightly oral pill that could be the first pharmacological treatment to improve oxygenation during sleep by directly targeting the underlying neuromuscular dysfunction that causes the upper airway to collapse in people with obstructive sleep apnea (OSA). It is a first-in-class combination of aroxybutynin, a novel antimuscarinic, and atomoxetine, a selective norepinephrine reuptake inhibitor (NRI). Their combined pharmacological synergy targets the root neuromuscular cause of OSA. In a disease characterized by complex and invasive treatment options, AD109 may offer a simple solution to help improve oxygenation and overall health for people living with OSA. AD109 has successfully completed multiple Phase 1 and Phase 2 trials in OSA. The Phase 3 program is fully enrolled with topline results expected in mid-2025. About Obstructive Sleep Apnea Obstructive sleep apnea (OSA) is a serious, chronic sleep-related breathing disease in which the upper airway repeatedly collapses during sleep, leading to intermittent oxygen deprivation. It is caused by two overlapping mechanisms: neuromuscular dysfunction during sleep and predisposing anatomic abnormalities. It has been demonstrated that OSA affects people of all body types, ages and genders —there is no single 'face' of the disease. An estimated 80 million people in the United States and 1 billion people worldwide suffer from OSA. An individual with OSA can experience hundreds of sleep apnea events in a single night, each one reducing the blood oxygen levels and negatively impacting cellular functions vital to normal health and function. Failure to effectively treat OSA increases the risk of serious long-term health consequences, such as high blood pressure, cardiovascular disease and type 2 diabetes, along with impacts on quality of life, including daytime fatigue and impaired judgement. Yet, the majority of those diagnosed with OSA refuse, abandon, or underutilize treatment. Currently, no available pharmacological treatments directly address the underlying neuromuscular dysfunction that is present in all people with OSA. About Apnimed Apnimed is a privately held clinical-stage pharmaceutical company dedicated to transforming the treatment landscape for sleep-related breathing diseases. Apnimed envisions a new era where novel oral therapies simplify intervention, expand the reach of diagnosis and treatment, and help more people get the oxygen and restorative sleep needed to thrive. Based in Cambridge, Mass., Apnimed is advancing a robust pipeline of oral pharmaceutical product candidates designed to improve oxygenation in individuals living with OSA and other sleep-related breathing disorders. This includes AD109, which is currently in Phase 3 clinical trials for the treatment of mild, moderate and severe OSA, as well as several therapies being developed as part of our joint venture with Shionogi & Co., Ltd, through Shionogi Apnimed Sleep Science (SASS).
