Date: 2014-10-16
Type of information: Collaboration agreement
Compound: ularitide
Company: Cardiorentis (Switzerland) Roche (Switzerland)
Therapeutic area: Cardiovascular diseases
Type agreement: collaboration
Action mechanism: 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.
Disease: acute heart failure
Details: * On October 16, 2014, Cardiorentis, a privately held biopharmaceutical company, announced a collaboration with Roche to establish the therapeutic efficacy and safety of ularitide, the Company\'s investigational drug for acute heart failure (AHF). Under the terms of the collaboration, Cardiorentis will incorporate Roche\'s advanced in vitro diagnostic tests into its TRUE-AHF Phase III Study to characterize the pharmacological properties of ularitide, evaluate its benefit-risk profile and the appropriate clinical application in patients. The TRUE-AHF Phase III trial was initiated in August 2012. It is led by the international principal investigator Milton Packer, M.D., University Texas,Southwestern Medical Center in Dallas, Texas and includes over 200 centers across the U.S., Europe, Canada and Latin America. TRUE-AHF is an event driven trial, which may enroll up to 4,000 patients with acute heart failure. There are two co-primary endpoints. The first is a composite endpoint for acute heart failure which assesses a patient\'s symptoms and persistence or worsening of heart failure within the first 48 hours after treatment initiation. The second co-primary endpoint is cardiovascular mortality.
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