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Idorsia initiates the Phase 3 registration study with selatogrel for the treatment of acute myocardial infarction | |||
By: GlobeNewswire - 28 Jun 2021 | Back to overview list |
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Ad hoc announcement pursuant to Art. 53 LR
Allschwil, Switzerland – June 28, 2021 An AMI, or heart attack, is a life-threatening condition that occurs when blood flow to the heart muscle (myocardium) is suddenly decreased or completely cut off by a blood clot in one or more of the coronary vessels. An AMI requires immediate treatment, as any delay in intervention can result in irreversible damage to the heart muscle and adverse clinical outcomes. According to the US Centers for Disease Control and Prevention, each year more than 800,000 persons living in the US will suffer a heart attack.[1] Although the management of AMI has improved in recent decades, morbidity and mortality associated with AMI remain high. The majority of deaths occur outside the hospital.[2,3] Early action is crucial for survival and to preserve heart muscle. Besides aspirin, there are no treatment options currently available for the critical time from onset of AMI symptoms to first medical contact. The development of selatogrel in an autoinjector aims to fulfill this medical gap: upon symptoms suggestive of a heart attack, patients would self-inject selatogrel as early as possible and immediately call for emergency medical help. Martine Clozel, MD and Chief Scientific Officer at Idorsia, commented: Dr Deepak L. Bhatt, MD, MPH, Executive Director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital, Professor of Medicine at Harvard Medical School, and Chair of the Steering Committee for SOS-AMI, commented: To be effective, any antithrombotic treatment for use at the onset of AMI symptoms should be rapidly absorbed and potent, acting quickly to inhibit thrombus formation at an early stage. Inhibition should be reversed after a few hours to avoid interfering with later patient management decisions. It must also have an appropriate safety profile for use prior to formal diagnosis of AMI. Selatogrel has the potential to satisfy these necessary conditions. Selatogrel administered subcutaneously is a potent, highly selective, fast-acting, reversible P2Y12 receptor antagonist. Two published Phase 2 studies, one in patients with chronic coronary syndromes and one in patients with AMI showed fast and reversible inhibition of platelet aggregation. Subcutaneous administration of selatogrel 16 mg has demonstrated a rapid onset of action, within 15 minutes, with the magnitude of the effect extending over approximately eight hours. Selatogrel was safe and well tolerated in both studies.[6,7] About the Antares Pharma integrated drug delivery device About Selatogrel Outcome Study in suspected Acute Myocardial Infarction “SOS-AMI” A Special Protocol Assessment has been agreed with the FDA. This indicates the FDA is in agreement with the adequacy and acceptability of specific critical elements of overall protocol design (e.g., entry criteria, dose selection, endpoints and planned analyses) for a study intended to support a future marketing application. In December 2020, the FDA designated the investigation of selatogrel for the treatment of a suspected AMI in adult patients with a history of AMI as a “fast-track” development program. This designation is intended to promote communication and collaboration between the FDA and pharmaceutical companies for drugs that treat serious conditions and fill an unmet medical need. Guy Braunstein, MD and Head of Global Clinical Development at Idorsia, added: SOS-AMI has been designed as a patient-centric study in collaboration with patients. Patients participating in SOS-AMI will be trained by qualified professionals appointed at each study site, on how to recognize AMI symptoms, on how and where to self-inject treatment, and to call for emergency medical help immediately. Trainers will use standardized material mirrored across all countries, which has been developed with the support of education experts, feed-back from post-MI patients, and in alignment with current guidelines. The patient is empowered through focused education to take action. In addition, regular interaction is performed by telephone with the designated site trainer, minimizing the burden on the patient, particularly during times of a global pandemic. Dr Mary Mooney, Assistant professor at the School of Nursing and Midwifery, Trinity College Dublin, and Member of the Steering Committee for SOS-AMI, commented: Jean-Paul Clozel, MD and Chief Executive Officer, concluded: Notes to the editor Investor webcast Date: Monday June 28, 2021 Webcast participants should visit Idorsia’s website www.idorsia.com 10-15 minutes before the webcast is due to start. Dial-in: CH: +41 44 580 6522 | UK: +44 20 3009 2470 | US: +1 877 423 0830 About acute myocardial infarction (AMI) The need for an early intervention has been highlighted by the guidelines of the European Society of Cardiology, which identified the prehospital phase as the most critical for high-risk patients and reiterated that efforts must be made to reduce the delay in initiation of treatment in order to reduce death.[4,5] Data supporting selatogrel in suspected AMI Idorsia has also completed a multi-center, open-label, randomized, exploratory study to assess the onset of platelet aggregation inhibition after a single subcutaneous injection of selatogrel in adults with acute myocardial infarction. In this study, 48 patients with confirmed diagnosis of AMI and time from onset of symptoms of more than 30 min and less than 6 hours were randomized to receive either selatogrel 8 mg or 16 mg in addition to conventional antithrombotic treatment (e.g., acetylsalicylic acid, oral P2Y12 receptor antagonists, anticoagulants). The primary objective of the study was to assess the inhibition of platelet aggregation 30 minutes after a single subcutaneous injection of selatogrel in patients with AMI.[7] About P2Y12 receptor antagonism About Dr Deepak L. Bhatt After graduating as valedictorian from Boston Latin School, Dr Bhatt obtained his undergraduate science degree as a National Merit Scholar at MIT while also serving as a research associate at Harvard Medical School. He received his medical doctorate from Cornell University and a Master of Public Health with a concentration in clinical effectiveness from Harvard University. His internship and residency in internal medicine were at the Hospital of the University of Pennsylvania, and his cardiovascular training was at Cleveland Clinic. He also completed fellowships in interventional cardiology and cerebral and peripheral vascular intervention and served as Chief Interventional Fellow at Cleveland Clinic, where he spent several years as an interventional cardiologist and an Associate Professor of Medicine. He served for many years as Director of the Interventional Cardiology Fellowship, Associate Director of the Cardiovascular Medicine Fellowship, and Associate Director of the Cardiovascular Coordinating Center. He was then recruited to be the Chief of Cardiology at VA Boston Healthcare System and served in that role for several years. He was a Senior Investigator in the TIMI Study Group for over a decade. He was selected by Brigham and Women’s Hospital as the 2014 Eugene Braunwald Scholar. He has been listed in Best Doctors in America from 2005 to 2020. He received the Eugene Braunwald Teaching Award for Excellence in the Teaching of Clinical Cardiology from Brigham and Women’s Hospital in 2017, ACC’s Distinguished Mentor Award in 2018, and AHA’s Distinguished Scientist Award in 2019. Dr Bhatt has authored or co-authored over 1650 publications and has been listed by the Web of Science Group as a Highly Cited Researcher from 2014 to 2020. He is the Editor of Cardiovascular Intervention: A Companion to Braunwald’s Heart Disease and of Opie's Cardiovascular Drugs: A Companion to Braunwald's Heart Disease. He is Senior Associate Editor for News and Clinical Trials for ACC.org. He is the Editor of the peer-reviewed Journal of Invasive Cardiology and Editor-in-Chief of the Harvard Heart Letter for patients. Dr Bhatt receives funding paid to Brigham and Women’s Hospital from Idorsia for his role as the Chair of the Steering Committee for SOS-AMI. About Dr Mary Mooney In terms of research funding, Mary has been Principal Investigator or a co-applicant across a range of projects, from a variety of funding sources. She has wide national and international collaborates with whom she is actively engaged in research. Mary maintains a clinical remit in cardiology, in addition to her academic role, and is an external examiner for post-graduate programs in other universities. As an elected committee member for the Irish Nurses Cardiovascular association (INCA), she contributes to the delivery of cardiovascular education of nurses in Ireland. She is actively engaged in research, most of which is concerned with cardiovascular or critical care. She has worked as a researcher and clinical advisor to an Irish Enterprise, funded by Enterprise Ireland She has been an invited speaker and presenter across a range of national and international events. Dr Mooney serves as a consultant to Idorsia. About Antares Pharma Inc. (NASDAQ: ATRS) Key literature
About Idorsia Headquartered near Basel, Switzerland – a European biotech-hub – Idorsia is specialized in the discovery, development and commercialization of small molecules to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team of professionals covering all disciplines from bench to bedside, state-of-the-art facilities, and a strong balance sheet – the ideal constellation to translate R&D efforts into business success. Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 900 highly qualified specialists dedicated to realizing our ambitious targets. For further information, please contact The above information contains certain "forward-looking statements", relating to the company's business, which can be identified by the use of forward-looking terminology such as "estimates", "believes", "expects", "may", "are expected to", "will", "will continue", "should", "would be", "seeks", "pending" or "anticipates" or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company's investment and research and development programs and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company's existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Attachment |
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