CAMBRIDGE, Mass.--(BUSINESS WIRE)--Biogen Idec (Nasdaq: BIIB) today announced the initiation of a Phase III clinical trial of intravenous (IV) ADENTRI® (BG9928), an adenosine A1 receptor antagonist, for acute decompensated heart failure (ADHF) patients with renal insufficiency. The trial will evaluate ADENTRI, which is being developed under a licensing agreement with CV Therapeutics (Nasdaq: CVTX), or placebo in addition to standard of care in approximately 900 patients in 21 countries globally, including the United States.
The TRIDENT-1 (TReatment with Intravenous BG9928 for patients with acutely DEcompensated heart failure and reNal insufficiency Trial) 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, M.D., Professor of Internal Medicine and Director of the Division of Cardiovascular Medicine, The Ohio State University Medical Center.
“We are excited to see ADENTRI enter into Phase III studies as one of Biogen Idec’s lead cardiopulmonary programs,” said Barry Ticho, M.D., Ph.D., Vice President, Cardiopulmonary and Emerging Therapies, Biogen Idec. “Following lixivaptan, ADENTRI marks the second novel compound in Biogen Idec’s cardiopulmonary franchise that is in Phase III clinical trials for heart failure patients. We look forward to advancing this and our other programs in the future.”
According to the American Heart Association, heart failure is the most common cause of hospitalizations in the U.S. Studies have shown that more than 60% of patients hospitalized with heart failure have renal insufficiency, which is an important independent determinant of survival and hospitalization in this clinical setting. The effect of renal insufficiency on acute decompensated heart failure patients is significant as these patients tend to retain fluid, which causes stress on both the cardiovascular and renal systems.
About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.
Biogen Idec Safe Harbor
This press release contains forward-looking statements regarding ADENTRI. These statements are based on Biogen Idec’s current beliefs and expectations. The commercial potential of ADENTRI is subject to a number of risks and uncertainties, including the risk of meeting the end points in clinical trials, other unexpected delays or hurdles, and the uncertainty of obtaining regulatory approval. Drug development and commercialization involves a high degree of risk.
For more detailed information on the risks and uncertainties associated with Biogen Idec’s drug development and other activities, see Item 1A "Risk Factors" in Biogen Idec’s most recent Form 10-Q filing with the Securities and Exchange Commission. These forward looking statements speak only as of the date of this press release, and we assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.