Biogen Idec initiates Ph III trial of Adentri

US drugmaker Biogen Idec has initiated a Phase III trial of intravenous Adentri (BG9928), an adenosine A1 receptor antagonist, for acute decompensated heart failure patients with renal insufficiency. The study will evaluate Adentri, which is being developed under a licensing agreement with CV Therapeutics, or placebo in addition to standard of care in approximately 900 patients, in 21 countries globally, including the USA.

The TRIDENT-1 study is a Phase III randomized, multi-center, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of IV Adentri dosed up to five days on body weight in ADHF patients with impaired renal function. Body weight is a measure of fluid accumulation, which is considered an important cause of symptoms experienced by heart failure patients.

"In previous clinical studies, Adentri has exhibited the potential to optimize fluid management without harmful effects on renal function. Heart failure patients with renal insufficiency are at risk for poor clinical outcomes and are among the most difficult to treat, as currently-available therapies negatively impact renal function," said lead investigator William Abraham, director of the Division of Cardiovascular Medicine, at the Ohio State University Medical Center.