Press Releases

Month: April 2019

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OMEICOS Therapeutics Announces First-Dosing in Phase 2 Clinical Study Evaluating its Lead Program OMT-28 in Patients with Persistent Atrial Fibrillation

Berlin, Germany, April 29, 2019

PROMISE-AF trial to deliver clinical proof-of-concept and determine Phase 3 dosing regimen for novel approach to stabilize the heart rhythm.

OMEICOS Therapeutics, a Berlin-based biopharmaceutical company developing first-in-class small molecule therapeutics for the prevention and treatment of cardiovascular and ophthalmic diseases, today announced the dosing of a first patient in a Phase 2 clinical study for the company’s OMT-28 development program. The placebo-controlled, double-blind, randomized PROMISE-AF study will evaluate the efficacy, safety, and population pharmacokinetics in patients with persistent Atrial Fibrillation (AF). The study is expected to enroll up to 120 patients via centers in four European countries. The completion of the PROMISE-AF trial is expected for H1 2020 and should enable OMEICOS to transition OMT-28 into Phase III clinical evaluation.

“In our first-in-man study, OMT-28 was shown to be safe with results strongly supporting OMT-28’s claim to have a low risk for pro-arrhythmia. We are thus very excited to further substantiate our clinical data set for OMT-28 in AF patients addressing a significant unmet medical need with a novel therapeutic approach,” said Dr. Robert Fischer, Chief Executive Officer and Chief Scientific Officer of OMEICOS Therapeutics. “OMT-28 targets the process of intracellular calcium regulation and mitochondrial function to stabilize the heart’s rhythm and in addition provides a cardioprotective effect. This mechanism sets it apart from currently marketed anti-arrhythmic drugs with the potential to make a real difference for the millions of patients suffering from AF. Since our therapeutic platform targets one of nature’s most important cell-protective pathways, clinical evaluation of OMT-28 in cardiovascular diseases could very well act as the cornerstone to branch out into multiple other indications.”

OMT-28 is a stable synthetic small molecule analog of the natural omega-3 fatty acid metabolite 17,18-EEQ, which has a structure optimized to provide high efficacy, safety and oral bioavailability. The compound has already proven its anti-arrhythmic, cardioprotective and anti-fibrotic potential in different in vivo models.

The primary goal of the PROMISE-AF trial is to evaluate the efficacy and safety of three different dose levels of OMT-28 administered once daily versus placebo and the drug’s impact on the maintenance of normal sinus rhythm in patients with persistent AF. To accurately detect and monitor arrhythmias and assess the AF burden for patients, data will be collected via an implantable cardiac monitor provided by Berlin-based medical device specialist Biotronik. 

More information on the PROMISE-AF study is available on https://www.clinicaltrials.gov.

About OMEICOS

OMEICOS Therapeutics is a spin-off company from the Max Delbrueck Center for Molecular Medicine (MDC) in Berlin. The company has discovered a series of metabolically robust synthetic analogues of omega-3 fatty acid-derived epoxyeicosanoids that have the potential to treat inflammatory, cardiovascular and other diseases. Epoxyeicosanoids, as a newly described class of bioactive lipid mediators, target one of nature’s most important cell-protective pathways, promoting organ and tissue protection. OMEICOS’ small molecules are orally available and show improved biological activity and pharmacokinetic properties compared to their natural counterparts. OMEICOS’ technology is based on ground-breaking scientific results in the field of omega-3 fatty acid metabolism and physiology obtained by the companies’ founders, Dr. Wolf-Hagen Schunck, Prof. John. R. Falck, Prof. Dominik Mueller and Dr. Robert Fischer. The companies’ research activities has been supported by a grant from the German Ministry of Education and Research (BMBF). www.omeicos.com

Contacts

OMEICOS Therapeutics GmbH
Dr. Robert Fischer, CEO, CSO
Phone: +49 (0) 30 9489 4810
E-Mail: r.fischer@omeicos.com
www.omeicos.com

Media requests

MacDougall Biomedical Communications
Mario Brkulj or Kara Mazey
Phone: +49 89 2424 3494 or +1 781-235-3060
E-Mail: omeicos@macbiocom.com

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Leonardo Caló, MD

Chief of the Department of Cardiology at Policlinic Casillino, Rome and Professor of Medicine at University Cattolica, Rome (Italy)
Dr. Leonardo Caló is focused on studying cardiac arrhythmias, electrophysiology and ablation and is an expert in the functional role played by omega-3 fatty acids in the prevention of arrhythmias in different settings. He is a Fellow of the European Society of Cardiology and has participated in several international clinical trials. He is associated Editor of Journal of Cardiovascular Interventional Electrophysiology and European Journal of Preventive Cardiology, has authored or co-authored numerous papers and more than 20 book chapters. Prof. Caló has participated in several international clinical trials.

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John Camm, MD, FRCP

Professor of Clinical Cardiology at St. George’s Hospital, University of London and at Imperial College, London (United Kingdom)

Dr. John Camm is focused on cardiac arrhythmias, atrial fibrillation, stroke prevention, clinical cardiac electrophysiology, heart failure and cardiomyopathy patients. He is President of the European Heart Rhythm Association and Founder of the Atrial Fibrillation Association and in addition, a Fellow of the Royal College of Physicians (London, Edinburgh and Glasgow), the American College of Cardiology, the American Heart Association and the European Society of Cardiology (ESC). Prof. Camm has written or edited more than 40 books and has authored or co-authored almost 1300 peer reviewed papers and over 500 book chapters in the field of cardiology and has been involved in the production of numerous guidelines, including the ESC guidelines for the management of atrial fibrillation. In 2010 and 2012, he was the recipient of the ESC Gold Medal and the British Cardiovascular Society’s Mackenzie Medal.

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Dobromir Dobrev, MD

Professor and Director of Institute of Institute of Pharmacology, University of Duisburg-Essen (Germany)

Dr. Dobromir Dobrev is an internationally recognized expert in understanding the cellular and molecular mechanisms underlying development, progression and maintenance of cardiac arrhythmias, particularly atrial fibrillation. He has authored over 200 peer reviewed articles and is on the editorial board of numerous cardiovascular journals. He is currently Chairman of ESC Working Group on Cardiac Cellular Electrophysiology and co-authored the 2016 ESC guidelines for the management of atrial fibrillation.

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Andreas Götte, MD, FEHRA

Professor and Head of Department of Cardiology and Intensive Care Medicine at St. Vincenz Hospital, Paderborn (Germany)

Dr. Andreas Götte is a specialist in interventional cardiology as well as clinical and experimental electrophysiology. The main focus of his research is on molecular mechanisms and molecular biology of atrial fibrillation. Since 2015 he is one of the Chairman of the German Atrial Fibrillation NETwork (AFNET). He was the Chair of the Scientific Program Committee of the European Heart Rhythm Association (EHRA), co-authored various international guidelines in atrial fibrillation treatment and published more than 150 peer reviewed papers.

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Gerald Naccarelli, MD, FACC, FAHA, FHRS, Bernard Trabin Chair in Cardiology

Professor of Medicine and Chief of the Division of Cardiology at Pennsylvania State University College of Medicine/Milton S Hershey Medical Center, Pennsylvania (USA)

Dr. Gerald Naccarelli Dr. Gerald Naccarelli is a cardiologist and arrhythmia expert who has been in clinical practice for 36 years. He is past-president of the Heart Rhythm Society (HRS) and served on the Board of Trustees of the American College of Cardiology and HRS. He is a recipient of the American Heart Association’s Paul Dudley White Award. Prof. Naccarelli has published over 600 peer reviewed papers, book chapters and reviews in addition to authoring four books related to cardiac arrhythmia. He is currently on the steering committee of multiple clinical trials and has vast experience in the development and approval of multiple anti-arrhythmic agents in the USA.

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Max Delbrück Center in the Helmholtz Association

Max Delbrück Center in the Helmholtz Association

As a spin-off from MDC Berlin, OMEICOS has continued a close collaboration with the working groups of OMEICOS’ co-founders Dr. Wolf-Hagen Schunck and Dr. Dominik Müller since its foundation. Joint research activities helped to further elucidate the molecular mode of action of OMEICOS compounds.

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University of Alberta

University of Alberta

OMEICOS is working closely together with the research group of John Seubert to investigate the effect of OMEICOS’ compounds in indications, associated with mitochondrial dysfunction.John’s research is focused on investigating the role of CYP epoxygenase metabolites in maintaining tissue homeostasis and reducing injury with a special focus on cardioprotection, ischemia-reperfusion, mitochondria, toxicology, the cytochrome P450 system and mechanisms of cellular death.

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Lipidomix

Lipidomix

Lipidomix GmbH is a specialized lipid analysis lab which conducts high-throughput lipidomic analysis, in particular eicosanoids. It is based on rapid-resolution-HPLC in combination with triple quad tandem mass spectrometry. Lipidomix develops and validates analysis methods for areas in the life sciences, food monitoring, forensics and others.

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Omegametrix

Omegametrix

Omegametrix is an international reference laboratory for the determination of the so called HS-Omega-3 Index®, a standardized method for erythrocyte fatty acid analysis. Dr. Clemens von Schacky, Head of Preventive Cardiology at the LMU Munich, together with Prof. W.S. Harris, Sanford University established the HS-Omega-3 Index® and founded Omegametrix in Martinsried, Germany, in 2007.

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Wolf-Hagen Schunck

Wolf is biochemist at the Max Delbrück Center for Molecular Medicine. He has over 30 years of research experience in the field of cytochrome P450 (CYP)-derived bioactive lipid mediators. Wolf’s laboratory identified 17,18-EEQ laying the scientific basis for the foundation of OMEICOS. In collaboration with fellow co-founder John R. Falck, he developed robust synthetic analogues for in vivo administration. The current work of Wolf is focused on further elucidating the cellular and molecular mechanisms underlying the unique biological properties of 17,18-EEQ and developing new fields of clinical application in collaboration with academic partners and OMEICOS.

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John R. Falck

John is the Welch Distinguished Chair of Chemistry and Professor at the University of Texas Southwestern Medical Center and has over 40 years of research experience in the field of medicinal and synthetic chemistry. He has pioneered the identification, preparation and chemical synthesis of a number of epoxyeicosatrienoic acids and is one of the foremost experts in the application of chemistry and pharmacology of CYP eicosanoids.

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Dominik N. Müller

Dominik is pharmacist and group leader at the Experimental and Clinical Research Center and Max Delbrück Center for Molecular Medicine. He has over 25 years of research experience in the field. His current work is focused on the crosstalk between immune cells, vasculature and target organs of hypertension. His research group’s major research interests are beside the understanding of pathomechanisms leading to cardiovascular disease, the identification of cardiovascular risk factors and new target for treatment.

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Robert Fischer

Robert’s passion is to transform excellent science into novel treatments for diseases with high unmet medical need. Prior to taking the lead at OMEICOS, he worked as a clinical cardiologist at the Charité – Universitätsmedizin Berlin and led or participated in many clinical and preclinical research in activities together with the Max-Delbrück-Center for Molecular Medicine. Robert holds a PhD in cardiovascular physiology from the Freie Universität zu Berlin and received Board-certification for Internal Medicine.

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Karen Uhlmann

Karen has more than 20 years’ experience in IP Asset Management, building and running organizations and being instrumental in raising funds, executing all different routes of commercialization. She holds a Master and a PhD in Biology from Freie Universität zu Berlin and Humboldt-Universität zu Berlin, and has earned a business degree from the Chamber of Commerce Berlin.

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Bernhard Kirschbaum

Chairman

Bernhard Kirschbaum studied biochemistry and physiological chemistry at the University of Konstanz and received his PhD in 1989. He moved on to work at the Rockefeller University and the Pasteur Institute before making a career in the pharmaceutical industry where he covered a broad range of technological and disease areas. In his most recent position, Dr. Kirschbaum served as head of Global Research and Early Development at Merck Serono where he was a member of the board.

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Christian Schneider

Christian Schneider, Managing Partner of Vesalius Biocapital, has been a venture capital executive for 20 years. He gained extensive experience in the areas of diagnostics, medtech, and therapeutics in the corporate life science and venture capital industry. Previously he held positions of increasing responsibility at Boehringer Mannheim, Centocor, and Johnson&Johnson. As a managing partner of VC firm PolyTechnos, he was responsible for OncoMethylome (IPO, 2006), Devgen (IPO, 2005) and Jerini (IPO, 2005). He was support partner for Addex (IPO, 2007) and BiPar (USD 500m sale to Sanofi-Aventis, 2009). He joined Vesalius in 2008 and is responsible for the portfolio companies Skyline (write-off), Activaero (EUR 130m sale to Vectura, 2014), Ventaleon, OMEICOS, Humedics and Mecuris where he serves on the boards. Dr. Schneider holds a doctorate degree in veterinary medicine (1992) and a PhD in immunology (1995), both from the University of Munich, Germany, and an MBA with focus on healthcare administration from Penn State University, Pennsylvania (1999).

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Peter Seiler

Head of Treasury Vice President SMS GmbH




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Taro Inaba

Taro Inaba is Founder and Managing Partner at Remiges Ventures. He has over 29 years of business experience including 19 years in start-up financing and company creation. At Remiges, Taro is engaged in technology sourcing, company creation, leading negotiation for investments and serving as director for seven of the Remiges’ portfolio companies. Prior to establishing Remiges Ventures, he spent 13 years at divisions of Mitsui & Co., Ltd. engaged in venture investment activities where he built and managed the biopharma investment team and investment portfolio. He served as President & CEO of Mitsui & Co. Venture Partners in Menlo Park, California from 2008 to 2009. Taro holds a B.E. in Polymer Chemistry, Kyoto University and MBA from European University. Taro is a CFA charter holder.

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Wolf-Hagen Schunck

Wolf-Hagen Schunck is biochemist at the Max Delbrück Center for Molecular Medicine in Berlin-Buch. He has over 30 years of research experience in the field of cytochrome P450 (CYP)-derived bioactive lipid mediators. Dr. Schunck’s laboratory identified 17,18-epoxyeicosatetraenoic acid (17,18-EEQ) laying the scientific basis for the foundation of OMEICOS. In collaboration with fellow co-founder Dr. John R. Falck, he developed robust synthetic analogues for in vivo administration. The current work of Dr. Schunck is focused on further elucidating the cellular and molecular mechanisms underlying the unique biological properties of 17,18-EEQ and developing new fields of clinical application in collaboration with academic partners and OMEICOS.

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Robert Fischer

CEO/CSO
Co-Founder

Robert’s passion is to transform excellent science into novel treatments for diseases with high unmet medical need. Prior to taking the lead at OMEICOS, he worked as a clinical cardiologist at the Charité – Universitätsmedizin Berlin and led and participated in many clinical and preclinical research in activities together with the Max-Delbrück-Center for Molecular Medicine. Robert holds a PhD in cardiovascular physiology from the Freie Universität zu Berlin and received Board-certification for Internal Medicine.

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Simon Russell

CBO, Consultancy

Simon’s career began in R&D before gaining over 20 years’ experience in senior commercial and business roles in AstraZeneca, Novartis AG and biotech. Following his last role as Head of Strategic Marketing for Biologics at Novartis, he became CBO of Creabilis Ltd leading commercial, corporate and business development ultimately negotiating its sale to Sienna Biopharmaceuticals with its subsequent IPO on NASDAQ. He is a co-founder of a biotech emerging from the Basel incubator initiative. Dr Russell studied Chemistry at the University of Oxford and received a PhD from Southampton University.

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Karen Uhlmann

Vice President Operations & IP
Co-Founder

Karen has more than 20 years’ experience in IP Asset Management, building and running organizations and being instrumental in raising funds, executing all different routes of commercialization. She holds a Master and a PhD in Biology from Freie Universität zu Berlin and Humboldt-Universität zu Berlin, and has earned a business degree from the Chamber of Commerce Berlin..

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Edita Bade

Head of Finance
& Controlling

Edita has gained more than 20 years of experience in various Finance, Controlling & Project Leader roles across a broad range of industries. Prior to joining OMEICOS, she supported the leadership team of an international Real Estate development company with the valuation and long-term value development projections of real estate opportunities, due diligence and acquisition/sales of these assets.

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Henk Streefkerk

Clinical Development, Consultancy

Henk, MD PhD, joined OMEICOS as Consultant ‘Clinical Development’ in September 2020. Henk is a medical doctor with a PhD in neurosurgery from University of Utrecht. He held multiple medical roles in large companies (Organon, Novartis) and biotech (Actelion, PIQUR), in translational medicine, safety, and clinical development in cardiovascular, oncology, and orphan diseases. Most recently, he was CMO of an Oncology Biotech in Basel. Henk supports OMEICOS in the overall clinical development of OMT-28.