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news.Trevena has initiated a Phase IIa clinical trial evaluating TRV120027 as a treatment for acute heart failure (AHF).
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TRV120027 is a beta-arrestin biased angiotensin II type 1 receptor (AT1R) ligand, the first biased ligand designed to treat patients with AHF.
The randomised, placebo-controlled, double-blind, dose-ranging Phase IIa study will evaluate the haemodynamic effects of TRV120027 in patients with stable heart failure.
The goal of the study is to demonstrate that TRV120027 rapidly and predictably improves hemodynamics while improving cardiac output and protecting renal function.
In patients with AHF, these titratable pharmacologic effects are expected to result in rapid symptom improvement.
The primary endpoints of the study are evaluation of the safety and tolerability of TRV120027 and measurement of its effects on pulmonary capillary wedge pressure.
Secondary trial endpoints include effects on other haemodynamic parameters, neurohormonal activation and renal markers.
The Phase IIa study is expected to enroll approximately 32 patients.
In a Phase II study which was completed in 2010, TRV120027 was shown to be safe, well-tolerated and have PK consistent with a high degree of titratability.