Scios announces results of ASCEND-HF trial for ADHF treatment

Nov 15 2010

Scios Inc. announced today that the landmark investigational study of NATRECOR^® (nesiritide) for the treatment of acutely decompensated heart failure (ADHF), ASCEND-HF, demonstrated no statistically significant difference from placebo in the co-primary endpoints of dyspnea, measured at six and 24 hours, or in the composite of heart failure re-hospitalizations and death during the first 30 days following treatment. Importantly, the study reinforced the safety profile of NATRECOR^®, revealing no excess adverse effects on renal function or mortality.

“This is the largest trial ever conducted in patients with ADHF, and affirms our commitment to patients and physicians who have limited treatment options to fight this life-threatening disorder.”

NATRECOR^® is approved for use by the U.S. Food and Drug Administration (FDA) for the treatment of patients with acutely decompensated heart failure who experience dyspnea (shortness of breath) at rest or with minimal activity with proven efficacy impact at three hours. Scios initiated the 7,141 patient ASCEND-HF study (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure) in 2007 after first seeking the guidance of an expert panel of cardiology and heart failure clinicians chaired by Eugene Braunwald, M.D., Harvard Medical School, in response to questions raised in the medical literature about mortality and impaired renal function of patients treated with NATRECOR^®.

"The ASCEND-HF trial has answered many scientific questions and has increased our understanding of the safety profile of NATRECOR^®," said Peter M. DiBattiste, M.D., Vice President of Cardiovascular Development at Johnson & Johnson Pharmaceutical Research and Development, L.L.C. "This is the largest trial ever conducted in patients with ADHF, and affirms our commitment to patients and physicians who have limited treatment options to fight this life-threatening disorder."

The results from ASCEND-HF will be submitted to the FDA as part of the standard collection of post-marketing drug experience.

Adrian F. Hernandez, M.D. MHS, Associate Professor, Duke Clinical Research Institute, presented the results during a late-breaking clinical trial presentation during the Scientific Sessions of the American Heart Association.

Review of Clinical Trial Results

In ASCEND-HF, NATRECOR^® did not show a statistically significant reduction in either of the composite co-primary endpoint measures: reduction of re-hospitalization due to heart failure or all-cause mortality during the first 30 days following treatment compared to placebo plus standard of care, (9.4% vs. 10.1%, respectively,>

Safety measures from ASCEND-HF showed that patients treated with NATRECOR^® plus standard care had a comparable mortality rate to patients treated with placebo plus standard of care at 30 days (3.6% vs. 4.0%,>®-treated patients with ADHF during the first 30 days based on a 25% decrease in glomerular filtration rate (31.4% vs. 29.5%,>® compared to placebo (26.6% vs. 15.3%, p<0.0001); however, the majority of these episodes were asymptomatic.