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By Catherine Hollingsworth
Staff Writer
Biogen Idec Inc. enrolled the first subject in its Phase III trial of injectable Adentri, which is being tested in a group that is considered particularly hard to treat: patients with worsening heart failure and poor kidney function.
The trial, known as TRIDENT (TReatment with Intravenous BG9928 for patients with acutely DEcompensated heart failure and reNal insufficiency Trial), is expected to enroll 900 patients in the U.S. and other countries. It is likely to take about two years to complete, based on the typical length of cardiovascular trials, a spokeswoman said.
The study is being developed under a licensing agreement with CV Therapeutics Inc., of Palo Alto, Calif.
Study patients will be given Adentri intravenously or placebo in addition to standard treatments, such as ACE inhibitors, beta blockers or diuretics.
Patients enrolled in the study have what is known as acute decompensated heart failure, as well as kidney failure. Those patients tend to retain fluid, causing stress on the heart and kidneys. They will be dosed by body weight, a measure of fluid accumulation and a major cause of symptoms in heart failure patients, according to Biogen Idec.
Studies have shown that more than 60 percent of patients hospitalized with heart failure have kidney failure, which is a key factor in determining survival and hospitalization, the Cambridge, Mass.-based company said.
Phase II results for Adentri published last year in the Journal of the American College of Cardiology showed that the drug was well tolerated and preserved renal function in patients with stable heart failure.
That study measured sodium levels, while the current study is looking at fluid retention. (See BioWorld Today, Aug. 15, 2007.)
Adentri is one of Biogen Idec's lead cardiopulmonary programs. It marks the second compound in the cardio area to enter Phase III for heart failure, after Lixivaptan for the treatment of hyponatremia in congestive heart failure patients. Biogen's other cardio compound is Phase II Aviptadil for pulmonary arterial hypertension. (See BioWorld Today, Feb. 15, 2008.)
Lixivaptan was acquired through a $200 million deal with Philadelphia-based Cardiokine Inc., while Aviptadil was licensed from mondoBiotech AG of Basel, Switzerland. (See BioWorld Today, Sept. 15, 2006, and July 3, 2007.)
Biogen Idec is relatively new to the cardiology space, and is best known for its blockbuster drugs in neurology, immunology and oncology: Rituxan (rituximab) for certain non-Hodgkin's lymphomas and for moderate to severe active rheumatoid arthritis, and Avonex (interferon beta 1-a) for relapsing forms of multiple sclerosis.
Hamed Khorsand, an analyst with BWS Financial, said the entry of Biogen Idec into the cardiovascular space is viewed as "a positive" because it expands their pipeline and opens up a whole new market for them. However, he said that the potential market size would not be very excessive.
Biogen's other approved product, Tysabri (natalizumab), was reintroduced to the U.S. market in June 2006 as a monotherapy for relapsing forms of multiple sclerosis and was approved by the European Commission that year as a single disease modifying therapy in highly active relapsing remitting MS.
Shares in Biogen Idec (NASDAQ:BIIB) fell 78 cents, closing at $52.38. | 
