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

May 22, 2015, 06:00 ET from Cardiorentis AG

ZUG, Switzerland, May 22, 2015 /PRNewswire/ -- 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," said Johannes 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.

About Cardiorentis Ltd.
Cardiorentis is a private biopharmaceutical company headquartered in Zug, Switzerland. The company is committed to bringing novel therapies to the treatment of heart failure and related cardiovascular diseases. Cardiorentis' disease-based technology platform integrates expertise in protein biology to identify novel targets and rationally design small molecule compounds and peptides for markets with unmet medical needs. For more information, visit www.cardiorentis.com.

Anker SD, Ponikowski P, Mitrovic V, Peacock WF, Filippatos G. Ularitide for the treatment of acute decompensated heart failure: from preclinical to clinical  studies. Eur Heart J. 2015 Mar 21;36(12):715-23. doi: 10.1093/eurheartj/ehu484. Epub 2015 Feb 10. Review. PubMed PMID: 25670819.
2 Fang J, Mensah GA, Croft JB, Keenan NL. Heart failure-related hospitalization in the U.S.,1979 to 2004. J Am Coll Cardiol 2008;52(6):428-34.
3 McMurray JJ, Petrie MC, Murdoch DR, Davie AP. Clinical epidemiology of heart failure: public and private health burden. Eur Heart J 1998; 19 Suppl P:P9. [http://www.uptodate.com/contents/epidemiology-and-causes-of-heart-failure/abstract/8 ].
4 Organisation for Economic Co-operation and Development. Health care utilisation – Hospital discharges by diagnostic categories – All causes (http://stats.oecd.org/).

Contacts:
For Cardiorentis:
Noele Thomas
+41 41 748 6030
noele.thomas@cardiorentis.com
or
Kellie Walsh
1-914-315-6072
kwalsh@kwmcommunications.com

SOURCE Cardiorentis AG



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http://www.cardiorentis.com