Making a Real Impact on

Severe Human Diseases

and Patient’s Life

Establishing a Pipeline of Differentiated Drug Candidates

OMEICOS’ pipeline is based on our proprietary approach that targets one of nature’s most important cell-protective pathways combined with industry-leading knowledge of omega-3 fatty acid metabolism and biology. Using these capabilities, we have established a broad compound library, are evaluating selected compounds in a number of therapeutic applications.

Due to the cardioprotective, neuroprotective, anti-inflammatory and immune-modulating properties of the compounds, this could open up novel therapeutic concepts for the prevention and treatment of several diseases.

Pipeline

PROMISE-AF: A new Treatment Option for AFib in Phase 2 Clinical Trial

Our most advanced therapeutic candidate, OMT-28, is currently being evaluated in a randomized, double-blinded, placebo-controlled, multi-center Phase 2 clinical trial, which focuses on maintenance of sinus rhythm in patients suffering from non-permanent Atrial Fibrillation. The trial is aimed at establishing a robust clinical proof-of-concept and conclude on dose finding for a fast transition into pivotal trials.

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. Our compound has already proven its anti-arrhythmic, cardioprotective and anti-fibrotic potential in different in vivo models.

In a previously performed Phase 1 study, OMT-28 exhibited an excellent tolerability profile and showing no safety signals in vital signs or safety laboratory parameters up to the maximum dose tested of 60 mg. The randomized, double-blind, placebo-controlled Phase 1 study was conducted at two centers in Germany and enrolled 75 subjects.

High-resolution electrocardiography recordings were used to detect any heart beat anomalies such as QT-prolongations and changes in the PR and QRS intervals. OMT-28 did not have a clinically relevant effect on these heart rate parameters or on cardiac conduction at all doses tested in the trial which strongly supports OMT-28’s claim to have a low risk for pro-arrhythmia. The results of the first-in-human trial demonstrate that OMT-28’s pharmacokinetic profile allows a once daily oral treatment. Additional parameters analyzed in the trial were the impact of the subject’s gender or diet on the uptake and metabolism of OMT-28.

Avoiding a Commonly Known Paradox

The tendency of existing and commonly prescribed antiarrhythmic drugs to lead to the emergence of potentially life-threatening arrhythmias is a well-documented paradox. In contrast to the current standard-of-care, our molecule does not interfere with the ion channels that are crucial for excitability and healthy patterns in cardiac conduction.

By further demonstrating these characteristics in clinical trials, OMEICOS intends to substantiate its claim that OMT-28 could become the first example of a complete novel class of drugs combining anti-arrhythmic, cardioprotective and anti-remodeling effects for long-term rhythm

Broadening the Pipeline in Ophthalmology

In addition to the company’s development activities in the cardiovascular space, OMEICOS has begun branching out into additional indications, initially focusing on severe eye disorders.

Exploratory work with OMEICOS’ therapeutic candidates included the generation of preclinical data comparing our approach to the current standard-of-care, injections of anti-VEGF therapies directly into the eye.

In a widely used mouse model for wet AMD, the choroidal neovascularization (CNV) model, OMEICOS’ approach reduced the formation of abnormal blood vessels and the leakiness of these blood vessels that is typical for wet AMD. The therapeutic effects of our approach observed in this model were comparable with the anti-VEGF therapy used, in this case Aflibercept. Taking into account that therapeutic compounds based on OMEICOS’ technology have the potential to be conveniently given to patients as a pill, avoiding the need for injections into the eye, these results provide a very solid basis for further development in these indications.

OMEICOS-sponsored Clinical Trials

We rely on a highly capable in-house team supported by a multifaceted network of clinicians and advisors for the clinical development of our proprietary products. The following trials are currently actively recruiting:

OMEICOS is conducting a phase 2 clinical trial to evaluate its lead compound OMT-28 in patients with recurring episodes of Atrial Fibrillation. For more information, please visit www.clinicaltrials.gov.

Guidance Provided by an Excellent Clinical Advisory Board

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.