Sequana Medical NV, an innovator in the management of fluid overload in liver disease, malignant ascites and heart failure, announces the appointments of Dr. Michael Felker and Dr. James Udelson as new Heart Failure Scientific Advisors.
They join current advisors Dr. Javed Butler, Dr. Maria Rosa Costanzo, Dr. Wilson Tang and Dr. Jeffrey Testani as Heart Failure Scientific Advisors to Sequana Medical. The Sequana Medical management team is working closely with its advisors on the development of alfapump DSR (Direct Sodium Removal).
Built on its proven alfapump platform, alfapump DSR is Sequana Medical’s breakthrough approach for the management of fluid overload in patients suffering from heart failure. Pre-clinical and clinical proof-of-concept data from a first-in-human single dose DSR study demonstrated that single dose DSR therapy was safe and well-tolerated and the positive results were published in the high impact peer-reviewed cardiovascular journal, Circulation. Sequana Medical is currently conducting RED DESERT, a repeated dose alfapump DSR study in diuretic-resistant heart failure patients and expects to report interim results in Q4 2020 and top-line results in H1 2021.
“There is an urgent medical need for new treatment options for diuretic-resistant heart failure patients and I look forward to working with the Sequana Medical team and advisors to support the ongoing development of alfapump DSR to address this need,” said Dr. Felker. “The alfapump DSR has the potential to offer a much-needed alternative treatment option for this underserved patient population, who are so challenging to treat with current therapies. Sequana Medical has made good progress with the alfapump DSR with impressive pre-clinical and early clinical data, and I look forward to playing a part in the ongoing development of this exciting product,” added Dr. Udelson.
“I am delighted that Dr. Felker and Dr. Udelson have agreed to join our group of Heart Failure Scientific Advisors – they are renowned experts in the field and their knowledge and experience, alongside that of our existing advisors, will be invaluable as we work to bring alfapump DSR to this large patient group that has limited current options”, said Ian Crosbie, Chief Executive Officer of Sequana Medical. “The global heart failure market represents a tremendous opportunity for Sequana Medical and we look forward to providing an update on the interim results from our RED DESERT study later this year.”
About Dr. Felker
G. Michael Felker, MD, MHS, FACC, FAHA, FHFSA is Professor of Medicine with tenure in the Division of Cardiology at Duke University School of Medicine. He is Director of Cardiovascular Research at the Duke Clinical Research Institute and Vice-Chief for Clinical Research in the Division of Cardiology. Dr. Felker’s research focus is on clinical trials in acute and chronic heart failure and the use of biomarkers as diagnostics, prognostic, and therapeutic tools in heart failure. He has published over 320 peer reviewed articles and book chapters in the field of heart failure and has served on the executive and steering committees for multiple national and international clinical trials in heart failure. Previously, he was Chief of the Heart Failure Section at Duke University School of Medicine from 2013 to 2020.
About Dr. Udelson
James E. Udelson, MD is Chief of the Division of Cardiology at Tufts Medical Center and Professor of Medicine and Radiology at Tufts University School of Medicine. Dr. Udelson’s research interests involve studying the effects of new therapeutic modalities in the setting of heart failure as well as acute and chronic coronary artery disease, and the development of imaging modalities to assess those effects. Dr. Udelson has directed and/or participated in numerous clinical trials on heart failure and cardiac imaging, focusing on the role of new therapies and how they affect remodeling, physiology, function, and outcomes. Dr. Udelson has served as a member of the FDA Medical Imaging Drugs Advisory Panel and has been invited as an ad hoc member of the FDA’s Cardiovascular and Renal Drugs Advisory Panel and the Peripheral and Central Nervous System Advisory Panel.