Aroxybutynin/Atomoxetine

Obstructive sleep apnea (OSA) is a serious, chronic sleep-related breathing disease that impacts an estimated 80 million people in the United States and nearly 1 billion globally. Untreated OSA carries profound health and quality-of-life consequences. It increases the risk of cardiovascular disease, type 2 diabetes, depression, and cognitive decline. However, the effects extend further into daily activities; insights from a recent survey show that more than 70% of people with OSA experience significant fatigue and daytime sleepiness, while 92% cite negative impacts on their work productivity and 86% are limited in their ability to perform daily activities. Despite its widespread prevalence and significant burden, a large majority of patients with OSA remain largely underdiagnosed and undertreated. More concerning, even among those who are diagnosed, the majority refuse, abandon or underutilize treatment often due to the complexity, invasiveness, or discomfort with existing options. This stark reality underscores the urgent need for innovative therapies that not only address the physiological causes of OSA but also fit seamlessly into patients’ lives. The recent FDA approval of the GLP-1 therapy tirzepatide for OSA represents a significant milestone in the treatment landscape for this complex disease. GLP-1 therapies have demonstrated efficacy in weight loss, including in patients with OSA. But as recent research confirms, the majority of patients with OSA do not have obesity, and in recent trials, even those who lost weight on a GLP-1 therapy had substantial residual OSA requiring further treatment. presented by Health IT Transforming Patient Care: The Role of AI-Powered Assistants The progress in artificial intelligence (AI) is reshaping patient care, across various dimensions, from facilitating faster discharge to curating treatment plans and suggesting lifestyle changes. By IT Medical The complexity of OSA requires a comprehensive approach The pathophysiology of OSA typically rests on two concurrent mechanisms. First, almost all patients with OSA have some degree of anatomic narrowing in the upper airway. This narrowing can result from various factors and obesity is just one of them. In addition, a narrow airway alone is insufficient to cause OSA. The disease is typically triggered by a neuromuscular dysfunction, characterized by an abnormal loss of muscle tone in the upper airway muscles at sleep onset. Treatment of this neuromuscular abnormality, whether by a pharmacologic approach or electrical stimulation, has been shown to be effective in addressing OSA in patients with and without obesity. To truly transform OSA care, we must adopt an expansive approach to treatment — one that addresses the diverse needs of patients and targets specific mechanisms of a multifaceted disease. A paradigm where individuals with OSA have a variety of treatment options to help them get the oxygen and sleep they need. It is this approach that will provide the greatest chance of improving the lives of the 80 million Americans with OSA. A patient-centric vision for the next five years presented by Market Trends to Watch for Health Systems and Their Specialty Pharmacies The future looks bright for the integrated specialty pharmacy model – for health systems, providers, and most importantly, for patients. By Jake Gaffey, MBA, Chief Strategy Officer at Shields Health Solutions Imagine an OSA treatment paradigm where patients are not confined to a single path but can choose from a variety of effective options tailored to their unique needs. Many serious chronic illnesses are managed this way, and over the next five years, I believe we have the potential to reach this vision, driven by innovation, collaboration, and a commitment to improving patient outcomes. Clinicians and patients will have more tools than ever to construct personalized treatment programs for OSA: Weight loss therapies – GLP-1 therapies represent an important advance for patients with obesity-related OSA. While weight loss has long been an adjunctive therapy for OSA, this approach to medical weight loss has delivered a realistic solution to improve OSA in a subset of patients. Neuromuscular therapies – Innovations targeting the neuromuscular dysfunction of OSA such as AD109 represent an exciting frontier in OSA treatment. These therapies address the root cause of airway collapse during sleep, offering a solution for patients across a broad spectrum of the disease. Device-based solutions – CPAP and other device therapies will continue to play a crucial role, especially for those who respond well to mechanical airway support. These therapies are not competitors — they are collaborators in the effort to ensure that all OSA patients, regardless of their unique situations, have access to effective, tailored care. Ultimately, the category will evolve in a manner that is consistent with the way other common chronic diseases are treated. I expect multiple treatment approaches will soon be available to address the different mechanisms of the disease and the varying needs of the heterogeneous population of people living with OSA. The role of innovation in closing the gap There is a profound need for diverse treatment options. The rapid pace of enrollment in OSA research and trials underscores this need. This enthusiasm is a reminder that innovation must be both effective and accessible to truly make an impact. Developing novel pharmacological therapies, including once-nightly oral treatments designed to target the neuromuscular dysfunction underlying airway collapse, is one way to address this unmet need. Simplifying treatment with oral options has the potential to lower barriers to care, enhance adherence, and ultimately improve outcomes for millions of people. A call to action As we move forward, the mission is clear: we must think beyond one-size-fits-all solutions and embrace the diversity of OSA. This means continuing to innovate, collaborating across sectors, and keeping patients at the center of every decision. This is an exciting moment for the OSA community — a moment to reflect on progress, recognize ongoing challenges, and double down on the work needed to transform care. Together, we can make that vision a reality.

Senior financial executive Ramzi Benamar joins leadership team as Chief Financial Officer Experienced board member, Chief Financial Officer and strategic consultant Gary Sender joins board of directors to Chair the Finance Committee Both appointments precede multiple value-creating catalysts, including Phase 3 results for AD109 as a first potential oral treatment for obstructive sleep apnea (OSA) CAMBRIDGE, Mass., Oct. 23, 2024 /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 the appointments of Ramzi Benamar as Chief Financial Officer and Gary Sender to the Board of Directors and as Chair of the Finance committee. The strengthening of both the leadership team and Board of Directors brings decades of combined experience in critical functions, such as financial management, strategic planning, company capitalization, investor relations and corporate mergers and acquisitions. "We are pleased to welcome both Ramzi and Gary to Apnimed, as they bring proven leadership experience in leading-edge, science-driven companies, across a broad range of critical finance and strategic functions. I am confident their additions will help to continue to drive forward our financial strategy, deliver on key operational priorities, and build long-term shareholder value," said Larry Miller, MD, Chief Executive Officer of Apnimed. "These appointments come at a critical time, as we look forward to next year's Phase 3 clinical trial results for AD109 and preparation for its potential commercial launch as a once-nightly oral therapy for OSA." Mr. Benamar commented, "I am incredibly excited to join the Apnimed team during this transformational time for the company. With its ongoing, late-stage clinical development program for AD109 in OSA, a value generating joint-venture with Shionogi and a strong existing investor base, Apnimed is well-positioned to serve the needs of all stakeholders, and I look forward to contributing to the achievement of its next phase of growth." "Apnimed is in an excellent position to accelerate into the next stage of corporate development," noted Mr. Sender. "I am eager to contribute to the financial and strategic initiatives of the company and am confident in the organization's continued clinical and future commercial successes." About Ramzi Benamar, Chief Financial Officer Ramzi Benamar has over 25 years of experience in the biotech and pharma industry, where he has an extensive track record of supporting the development and commercialization of novel pharmaceutical products and serving in executive financial leadership roles in both public and private companies. Ramzi has led several rounds of financing as a CFO amounting to about $600M. He served as the CFO of BELLUS Health, where he contributed to the growth of the company toward its acquisition by GSK. Ramzi was also the CFO at DBV Technologies and Elucida, and Vice President and Head of Financial Planning and Analysis for Spark Therapeutics until its acquisition by Roche Holdings. Earlier in his career, Ramzi held numerous positions of increasing responsibilities in finance, strategy, and operations at various pharma companies including Shire, Johnson & Johnson, and Merck. He holds a bachelor's and master's degree in business administration from Temple University, and a master's degree from the University of the Sciences in Philadelphia (Saint Joseph's University). About Gary Sender, Independent Director and Chair of Finance Committee Gary Sender has extensive financial leadership experience across the biopharmaceutical industry, including serving on the board of directors of several public and private biotechnology companies. Mr. Sender joined the Board of Directors of both Schrödinger, Inc., and Harmony Biosciences when they were both private companies and currently Chairs both respective Audit Committees and the Schrödinger Compensation Committee. He currently Chairs the Audit Committee and serves on the Compensation Committee of iBio. Mr. Sender also joined the Board of Directors of Gennao Bio (Private) in September of 2021 and currently Chairs both the Audit and Compensation committees. In March 2021, Mr. Sender retired as the Chief Financial Officer of Nabriva plc. Prior to Nabriva, he was the Chief Financial Officer of Synergy Pharmaceuticals. Previously, Mr. Sender was the Senior Vice President of Finance for Shire plc, supporting its global commercial businesses and all functions of its specialty pharmaceuticals business. Prior to joining Shire, he was the Chief Financial Officer of Tengion, Inc. Earlier in his career, Mr. Sender held several increasingly senior finance-related roles, including a 15-year career at Merck & Co., Inc., most recently serving as Vice President and Controller for Merck's U.S. pharmaceuticals business. Mr. Sender earned his bachelor's degree in finance and management information systems from Boston University. He received his master's degree in industrial administration (MBA) with a concentration in Finance from Carnegie-Mellon University. 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 stop breathing, exposing them to serious, long-term health risks. An individual with OSA can experience hundreds of 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 apnimed.com or follow us on X and LinkedIn. Media Contact: [email protected] Investor Contact: Brian Ritchie [email protected] SOURCE Apnimed, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED