Trevena has initiated a Phase IIa clinical trial to evaluate TRV120027 as a treatment for acute heart failure.
The randomised, placebo-controlled, double-blind, dose-ranging trial 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.
The primary endpoints of the study are evaluation of the safety and tolerability of TRV120027 and the measurement of its effects on pulmonary capillary wedge pressure.
Secondary trial endpoints include effects on other haemodynamic parameters, neurohormonal activation and renal markers.
The study is expected to enrol approximately 32 patients.
In another Phase II study completed in 2010, TRV120027 was shown to be safe, well-tolerated and have pharmoknietics consistent with a high degree of titratability.
TRV120027 is a beta-arrestin biased angiotensin II type 1 receptor ligand, the first biased ligand designed to treat patients with acute heart failure.
