Cardiorentis, a Switzerland-based, privately held biopharmaceutical company, is collaborating with Roche to establish the therapeutic efficacy and safety of Ularitide, the company's investigational drug for acute heart failure (AHF). 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.
"Our in vitro diagnostic tests provide critical clinical information addressing doctor's needs to guide the patient's treatment regime. Incorporating these tests into the TRUE-AHF trial will enable us to further validate their clinical value in a large patient population, but more importantly advance the development of new treatment options for acute heart failure," said professor Christian Zaugg, head of disease area strategy at Roche Professional Diagnostics.
The TRUE-AHF phase III trial was initiated in August 2012. It is led by Principal Investigator Milton Packer, M.D., University Texas, Southwestern Medical Center, 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 is cardiovascular mortality.