Sleep Apnea, Central

OSAKA, Japan, April 25, 2025 - Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") announced that it has entered into an agreement with Apnimed, Inc. (Head Office: Massachusetts, USA; Chief Executive Officer: Lawrence G. Miller, MD; hereafter "Apnimed") for the introduction of sulthiame* and a new drug development program. * Sulthiame: A carbonic anhydrase inhibitor approved as an antiepileptic drug in certain regions. Sulthiame has successfully completed two Phase 2 trials in over 300 obstructive sleep apnea (OSA) patients studied for up to 3 months in Europe.1 With the conclusion of this agreement, Shionogi acquired a joint ownership interest in the intellectual property rights related to the use of sulthiame in the field of sleep apnea and also in other intellectual property rights related to a different drug development program of Apnimed by paying a one-time fee to Apnimed.※ Furthermore, Shionogi and Apnimed have already equally contributed this intellectual property to SASS, which will now conduct thefuture research and development of sulthiame and the other drug development program. ※ Note: Shionogi retains exclusive negotiation rights for the development and sales rights in Japan, Korea, Taiwan, and China. “We are pleased to add new assets to the SASS OSA pipeline,” said John Keller, Ph.D., Senior Executive Officer, Senior Vice President, R&D Supervisory Unit at Shionogi. “Our joint venture, combining the scientific and medical resources of Apnimed and Shionogi, represents the most robust global effort to bring new pharmacologic treatments for people with sleep apnea and related disorders.” “We are delighted to announce that this transaction further strengthened our SASS pipeline,” commented Larry Miller, MD, Chief Executive Officer of Apnimed. “The 80 million people with OSA in the US, and hundreds of millions more around the globe, need more convenient options that directly treat the root causes of OSA.” Shionogi has identified Contributing to a Healthy and Prosperous Life as one of our material focus area. We are committed to creating a society where everyone can lead a longer, more vibrant life, realizing their goals. Through the partnership with Apnimed, Shionogi continues to strive to deliver innovative treatments for diseases with high unmet medical needs, including sleep apnea and related disorders, to patients as quickly as possible. About Apnimed Apnimed, based in Cambridge, Massachusetts, is a pharmaceutical company with exceptional expertise in sleep disorders. The company is building a portfolio of novel drug treatments for sleep-related breathing disorders, including Sleep Apnea Syndrome (SAS). Apnimed's lead development candidate, AD109, aims to maintain upper airway patency during sleep with a once-daily oral medication for the treatment of OSA, which, if approved, could bring a dramatic change to conventional therapies for OSA. For more details, please visit apnimed.com, X, or LinkedIn. About Shionogi-Apnimed Sleep Science, LLC In November 2023, Shionogi and Apnimed established a joint venture, Shionogi-Apnimed Sleep Science, LLC, with each company holding a 50% stake. 2 The aim of SASS is to provide promising solutions to meet the unmet needs in the field of sleep disorders. SASS combines Shionogi's capabilities in small molecule drug discovery, first-in-class and best-in-class compound creation with Apnimed's advanced expertise in the field of sleep disorders, including a highly experienced clinical-stage drug development team and a strong network with clinical facilities. This collaboration leverages superior translational research to create promising solutions in the field of sleep disorders more rapidly than either company could achieve alone. References: 1. Hedner et al. Efficacy, Safety, and Tolerability of Three Doses of Sulthiame in Patients With Obstructive Sleep Apnea. A Randomized, Double-blind, Placebo Controlled, Dose-ranging Study (STM-042/K). B14. American Thoracic Society Annual Meeting 2024. 2. Press Release: November 1, 2023 - Establishment of a Joint Venture Company with Apnimed for Solving Challenges in Sleep Disorders Forward-Looking Statements This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. For Further Information, Contact: SHIONOGI Website Inquiry Form: https://www.shionogi.com/global/en/contact.html

First Patient Dosed in Phase 2A Dose-Finding, Proof-of-Concept RESTEADY Trial Evaluating SASS-001 in a Sub-Population of Patients with Sleep Apnea with a Central Component; Top-line Data Expected in 1H 2026 SASS-001, a Novel Drug Combination of Sivopixant and a second compound, is the first clinical stage asset from Apnimed's Joint Venture with Shionogi Both Phase 3 Trials (SynAIRgy and LunAIRo) evaluating AD109 in Mild, Moderate and Severe Obstructive Sleep Apnea (OSA) patients of all body types remain on track for top-line results expected in Q2 and Q3 2025, respectively CAMBRIDGE, Mass., April 7, 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 that the first patient has been dosed in the Phase 2A RESTEADY trial evaluating the novel oral drug combination, SASS-001, in an underserved population of patients suffering from sleep apnea with a central component. Top-line results from the study are expected in the first half of 2026. SASS-001 represents the first clinical stage asset from Shionogi-Apnimed Sleep Science, LLC (SASS), Apnimed's joint venture with Shionogi & Co., Ltd. (Shionogi). "With the first patient dosed in the Phase 2A RESTEADY trial, both Apnimed and SASS have reached an important milestone – the advancement of a scientific hypothesis to clinical development," commented Larry Miller, MD, Chief Executive Officer of Apnimed. "Today's announcement represents the combined efforts of the Apnimed and Shionogi teams, highlighting their respective strengths in sleep medicine drug development and drug discovery." RESTEADY is a Phase 2A, multicenter, double-blind randomized, controlled, dose escalation, parallel-arm, safety and efficacy study evaluating SASS-001 in adult patients suffering from sleep apnea with a central component (NCT06776432). The study is expected to enroll approximately 60 patients from up to 10 U.S. clinical sites. Patients will be randomized in a 3:1 ratio to either dose-escalating SASS-001 or a placebo arm. Patient participation in the study is approximately 10 weeks, with trial measures to include sleep-clinic polysomnography and at-home sleep evaluations. Apnimed's most advanced clinical program, AD109, also continues to progress following the conclusion of enrollment in both Phase 3 clinical trials, LunAIRo and SynAIRgy. The Company continues to anticipate the availability of top-line data from both trials in Q2 and Q3 2025, respectively. AD109 is being studied in obese and non-obese adult patients with mild, moderate and severe OSA. About SASS and SASS-001 SASS is a joint venture of Apnimed and Shionogi focused on accelerating the discovery, preclinical and clinical development of novel pharmacologic solutions designed to address the complex pathology of sleep apnea and other sleep related diseases. SASS-001 is an investigational oral clinical candidate under development by SASS for sleep apnea with a central component. The candidate is a combination of sivopixant, a selective P2X3 receptor antagonist, and a second compound. About Sleep Apnea with a Central Component Sleep apnea with a central component is characterized by the concomitant presence of obstructive and central apneas. In central apneas, breathing temporarily stops due to absence of the signal from the nervous system to respiratory muscles to initiate a breath. This mechanism is different from the neuromuscular dysfunction that is thought to cause OSA, in which a breath is initiated but airflow is prevented by a physical occlusion of the airway despite contraction of respiratory muscles. Central and obstructive apneas often coexist in an individual patient, particularly in those with concomitant cardiovascular diseases such as atrial fibrillation and heart failure. 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. We believe the introduction of simple, once-nightly oral drugs will 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 its growing 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 two Phase 3 clinical trials for the treatment of mild, moderate and severe OSA. Apnimed is developing several therapies through our joint venture with Shionogi & Co., Ltd., Shionogi Apnimed Sleep Science. Learn more at apnimed.com or follow us on X and LinkedIn. Media Contact: [email protected] Investor Contact: Ramzi Benamar [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

THURSDAY, March 20, 2025 -- Removing the tonsils and adenoids can improve the sleep of kids with mild breathing problems that disturb their slumber, a new clinical trial reports. Children with sleep problems needed to see a doctor 32% less often and had a 48% reduction in medication use after surgical removal of their tonsils and adenoids (adenotonsillectomy), researchers reported in the journal JAMA Pediatrics . The results mean that “for every 100 children, 125 encounters and 253 prescriptions can be avoided in the first year following surgery,” senior researcher Dr. Susan Redline , a professor of sleep medicine at Brigham and Women’s Hospital, said in a news release. As many as 17% of kids in the U.S. experience sleep-disordered breathing, in which snoring or full-blown sleep apnea causes them to wake repeatedly in the night, according to information cited in the news release. Taking out enlarged tonsils is standard treatment for moderate to severe cases, but the practice hadn’t been tested in kids with mild sleep-disturbed breathing. For this study, researchers analyzed data from a clinical trial involving 459 children with mild sleep-disordered breathing who were followed for a year. The kids were 3 to 12 and being treated at seven academic sleep centers across the U.S. During the trial, half the children had their tonsils and adenoids removed while the other half received supportive care without surgery that included education on healthy sleep habits and referrals for allergies or asthma. A year later, the kids who’d had their tonsils and adenoids removed were less likely to visit the doctor or take meds to help their sleep, results show. “The reduction in the rates of both total encounters and total prescriptions associated with surgery was more pronounced among children older than 5 years than among children 5 years and younger,” researchers noted in their study. Exactly how removal of the tonsils and adenoids may improve mild sleep-disordered breathing is not fully understood yet, researchers note. In addition, more research is needed to prove the cost-effectiveness of adenotonsillectomy compared with other care. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.