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. It is usually caused by a blood clot or blockage in one or more of the coronary vessels supplying blood to the heart muscle. An AMI requires immediate treatment and medical attention, as any delay in intervention can result in irreversible damage to the heart muscle. 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])

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 completed a multicenter, double blind, randomized, placebo-controlled study assessing the pharmacodynamics, pharmacokinetics, tolerability and safety of a single subcutaneous injection of selatogrel in adults with chronic coronary syndrome. In this study, 346 patients receiving conventional background oral antiplatelet therapy (e.g. acetylsalicylic acid, P2Y(12) receptor antagonists) were randomized to receive either selatogrel 8 mg, 16 mg or placebo. The primary objective of the study was to characterize inhibition of platelet aggregation relative to placebo after a single subcutaneous injection of selatogrel either in the thigh or in the abdomen at 2 different doses in patients with chronic coronary syndromes.([6])

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 P2Y(12) 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 P2Y(12) receptor antagonism

Platelet adhesion, activation and aggregation play a pivotal role in atherothrombosis. An essential element in the platelet activation process is the interaction of adenosine diphosphate (ADP) with the platelet P2Y(12) receptor. This platelet activation and aggregation can be inhibited by antagonizing the platelet P2Y(12) receptor. This prevents the binding of ADP

to the receptor, which reduces platelet aggregation and the reaction of platelets to stimuli of thrombus aggregation.

About Dr Deepak L. Bhatt

Deepak L. Bhatt MD, MPH, FACC, FAHA, FSCAI, FESC, is Executive Director of Interventional Cardiovascular Programs at Brigham and Women's Hospital and Professor of Medicine at Harvard Medical School.

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

Dr Mary Mooney (PhD, MSc, RGN, RM, RNT, MA, Higher. Diploma Cardiovascular Studies) is an assistant professor in the School of Nursing and Midwifery, Trinity College Dublin. Her research areas focus predominantly on cardiac-related aspects of patient care and nurse education. Her research experience encompasses qualitative and quantitative research methods, including randomized controlled trials. Mary's PhD was a randomized controlled trial that comprised delivering an educational intervention to patients with Acute Coronary Syndrome. This Health Research Board (HRB) funded study was the first RCT in the world to target and successfully reduce patient pre-hospital delay time and its groundbreaking effect has been renowned for its effectiveness in reducing patient delay in the presence of heart attack symptoms. Dr Mooney has many publications, is widely cited, and her work has contributed to the development of further international research with which she is currently actively engaged.

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)

Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address unmet needs in targeted therapeutic areas such as urology and endocrinology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies.

Key literature 


   1. Benjamin EJ, et al. Heart Disease and Stroke Statistics--2019 Update: A 
      Report From the American Heart Association. Circulation 
      2019;139(10):e56-e528. 
 
   2. Adnet F, et al. Incidence of acute myocardial infarction resulting in 
      sudden death outside the hospital. Emerg Med J. 2011;28(10):884--6. 
 
   3. Norris RM. Fatality outside hospital from acute coronary events in three 
      British health districts, 1994-5. United Kingdom Heart Attack Study 
      Collaborative Group. BMJ 1998;316(7137):1065--70. 
 
   4. Ibanez B, et al. 2017 ESC guidelines for the management of acute 
      myocardial infarction in patients presenting with ST-segment elevation. 
      Eur Heart J 2018;39(2):119--77 
 
   5. Neumann FJ, et al. 2018 ESC/EACTS guidelines on myocardial 
      revascularization. Eur Heart J 2019;40(2):87--165 
 
   6. Storey R. F, et al. Pharmacodynamics, pharmacokinetics, and safety of 
      single-dose subcutaneous administration of selatogrel, a novel P2Y12 
      receptor antagonist, in patients with chronic coronary syndromes. Eur 
      Heart J 2019;0, 1-9, doi:10.1093/eurheartj/ehz807 
 
   7. Sinnaeve P, et al. Subcutaneous Selatogrel Inhibits Platelet Aggregation 
      in Patients With Acute Myocardial Infarction. J Am Coll Cardiol. 2020 May 
      26;75(20):2588-2597. doi: 10.1016/j.jacc.2020.03.059. PMID: 32439008. 
 
   8. Juif P, et al. Clinical Pharmacology of the Reversible and Potent P2Y12 
      Receptor Antagonist ACT-246475 After Single Subcutaneous Administration 
      in Healthy Male Subjects. The Journal of Clinical Pharmacology 2019, 
      59(1): 123-130. doi:10.1002/jcph.1296

About Idorsia

Idorsia Ltd is reaching out for more -- We have more ideas, we see more opportunities and we want to help more patients. In order to achieve this, we will develop Idorsia into a leading biopharmaceutical company, with a strong scientific core.

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June 28, 2021 01:00 ET (05:00 GMT)