Cardiorentis Completes Enrollment in Pivotal Phase III Clinical Trial of Ularitide for Acute Heart Failure

ZUG, Switzerland, Cardiorentis AG, a privately held biopharmaceutical company, today announced that it has completed enrollment in TRUE-AHF, its pivotal Phase III clinical trial for the treatment of acute heart failure (AHF). 

The TRUE-AHF Phase III trial was initiated in August 2012. Led by principal investigator Milton Packer, M.D., University Texas, Southwestern Medical Center in Dallas, Texas, the study includes over 200 centers across the U.S., Europe, Canada and Latin America. TRUE-AHF is an event driven trial, which enrolled 2,157 patients with AHF. There are two co-primary endpoints. The first is a composite endpoint for AHF, which assesses a patient's symptoms and persistent or worsening heart failure within the first 48 hours after treatment initiation. The second co-primary endpoint is cardiovascular mortality.

"We achieved a critical milestone today and would like to personally thank all the investigators and their patients for contributing to this landmark trial. For the first time in medical history, we may be able to establish an evidence based therapy for AHF, a life-threatening condition that affects millions of people worldwide," saidJohannes Holzmeister, M.D., Chief Executive Officer and Chief Medical Officer, Cardiorentis.

About Ularitide

Ularitide is a natriuretic peptide in Phase III development as an intravenous (IV) infusion treatment for acute heart failure (AHF) limited by United States law to investigational use only. Ularitide is the chemically synthesized form of urodilatin - a human, natriuretic peptide that is produced in the kidneys and induces excretion of sodium into the urine (natriuresis) and increased urine production (diuresis) to regulate fluid balance and sodium haemostasis. Ularitide induces natriuresis and diuresis by binding to specific natriuretic peptide receptors (NPR-A, NPR-B and other natriuretic peptide receptors), thereby increasing intracellular cyclic guanosine monophosphate (cGMP) helping to relax smooth muscle tissues, leading to vasodilation and increased blood flow^[1].

About AHF

Heart failure is a growing problem worldwide. More than 26 million people around the world are affected^[2],[3]. AHF can be defined as the sudden or gradual onset of the signs or symptoms of heart failure resulting in a need for urgent therapy or hospitalisation. In 2011, there were nearly 3 million hospital admissions with heart failure as the primary diagnosis in countries across the globe^[4]. It is a life-threatening condition which requires immediate medical attention. Signs and symptoms of AHF include extreme fatigue and shortness of breath, worsening kidney function, severe swelling, sudden weight gain and a distended jugular vein along the side of the neck.

Source:  Cardiorentis AG