TARRYTOWN, N.Y.--(BUSINESS WIRE)--Sep 10, 2007 - Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) today announced that treatment with rilonacept (IL-1 Trap) demonstrated a statistically significant reduction in patient pain scores in a single-blind, placebo run-in-controlled study of 10 patients with chronic active gout. Mean patients' pain scores, the key symptom measure in persistent gout, were substantially reduced during blinded active treatment (-41%, p=0.025, during the first two weeks of active treatment, and -56%, p less than 0.004, after six weeks of active treatment), as compared to changes during the blinded two-week placebo run-in period (-13%, which was not statistically significant). In this study in which safety was the primary endpoint measure, treatment with rilonacept was generally well tolerated with mild injection-site reaction being the only reported drug-related adverse event.
This study enrolled patients with chronic active gout, who had been suffering ongoing persistent joint pain and inflammation for at least four weeks and for whom standard therapies were ineffective or associated with risks related to side effects. Disease activity changes during a blinded placebo run-in period were compared to changes during subsequent blinded treatment with rilonacept. After six weeks of rilonacept treatment, 70 percent of patients achieved at least a 50 percent improvement in their pain scores; none of the patients achieved a 50 percent improvement in their pain scores during the placebo run-in period. Other efficacy measures, including patients' and physicians' global assessments of disease activity and joint assessment scores, were improved with rilonacept treatment. Detailed data from the study will be presented at an upcoming scientific conference.
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"Rilonacept clearly improved patients' symptoms in this small pilot study that included refractory gout patients with chronic disease complicated by acute exacerbations," said Robert Terkeltaub, M.D., Professor of Medicine and Associate Division Director at the University of California at San Diego and Chief of Rheumatology at the Veterans Administration Medical Center. "These results are particularly noteworthy given that refractory patients such as these do not typically show spontaneous improvement in symptoms. Further studies of rilonacept are warranted in a variety of gout conditions, as large numbers of patients are dissatisfied with or intolerant to existing therapies."
"We are very pleased with the outcome of this exploratory proof-of-concept study. While this was a small study in a heterogeneous group of gout sufferers, it represents the first controlled and blinded study of an interleukin-1 (IL-1) blocking agent in gout. It is consistent with a wealth of preclinical data suggesting that IL-1 could be an important driver of pain and inflammation in gout," stated George D. Yancopoulos, M.D., Ph.D., President of Regeneron Research Laboratories. "Based upon these results, we are committed to further studying rilonacept in a variety of gout settings."
Regeneron is currently initiating a double-blind, placebo-controlled Phase 2 study of rilonacept in the prevention of gout flares induced by the initiation of uric acid-lowering drug therapy used to control the disease. Gout is often characterized by high blood levels of uric acid, a bodily waste product normally excreted by the kidneys. The uric acid can form crystals in the joints of the toes, ankles, knees, wrists, fingers, and elbows. Chronic treatment with uric acid-lowering medicines, such as allopurinol, is prescribed to eliminate the uric acid crystals and prevent reformation. During the first several months of therapy and before uric acid blood levels are sufficiently reduced, dissolution of the uric acid crystals can result in stimulation of inflammatory mediators, including IL-1, resulting in acute flares of joint pain and inflammation. This Phase 2 study will explore the safety and efficacy of rilonacept in preventing gout flares in patients initiating allopurinol therapy.
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