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news.Swiss biopharmaceutical firm Cardiorentis has completed patient enrollment in its pivotal Phase III clinical trial (TRUE-AHF) of Ularitide, a natriuretic peptide, to treat acute heart failure (AHF).
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A total of 2,157 patients with AHF were enrolled in the trial from over 200 centers across the US, Europe, Canada and Latin America.
The TRUE-AHF Phase III trial is led by principal investigator Milton Packer, University Texas, Southwestern Medical Center in Dallas, Texas.
In the trial, 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, while the second co-primary endpoint is cardiovascular mortality.
Cardiorentis chief executive officer and chief medical officer Johannes Holzmeister said: "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."
Ularitide, the chemically synthesized form of urodilatin, is in Phase III development as an intravenous (IV) infusion treatment for acute heart failure (AHF) limited by US law to investigational use only.
Urodilatin is 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.