Regeneron Reports Phase II Results for IL-1 Trap Clinical Program in Rheumatoid Arthritis
>>>Primary endpoints MISSED, but high dose shows improving efficacy/trend<<<
Tuesday October 7, 7:00 am ET
IL-1 Trap Phase II Study Demonstrates Clinical Activity and Favorable Safety and Tolerability Profile
TARRYTOWN, N.Y.--(BUSINESS WIRE)--Oct. 7, 2003-- Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN - News) announced today that the Company's IL-1 Trap demonstrated evidence of efficacy and safety in patients with rheumatoid arthritis (RA) in a Phase II dose-ranging study in approximately 200 patients. Patients treated with the highest dose, 100 milligrams (mg), of the IL-1 Trap exhibited improvements in primary and secondary end-points of the trial. When compared with placebo, subjects receiving 100 mg of IL-1 Trap demonstrated the following clinical and laboratory effects:
An increase in the proportion of ACR 20 responses (primary endpoint) - 46% vs. 30.9% (p=0.11)
An increase in the average ACR-N Score - 24.1% vs. 13.5%, (p=0.02)
An increase in the proportion of ACR 50 responses - 20.0 % vs. 9.1%, (p=0.11)
An increase in the proportion of ACR 70 responses - 12.0 % vs. 3.6%, (p=0.11)
A greater decrease in the Disease Activity Score (DAS) - -1.1 vs. -0.7 (p=0.02)
A faster time of onset of ACR 20 response (median time to onset) - 36 days vs. 77 days (p=0.03)
Increased benefit in those patients on concomitant disease modifying anti-rheumatic drugs (DMARDs) - ACR 20 of 50.0% vs. 33.3%, (p=0.16) and ACR 50 of 29.4% vs. 11.1% (p=0.06)
A decrease in C-Reactive Protein (CRP) a systemic marker of inflammation - -1.36 vs. + 0.07 (p=0.004)
The IL-1 Trap was generally well tolerated and was not associated with any serious adverse events. Of the patients treated with the IL-1 Trap, less than 5 percent developed antibodies against the molecule.
"This positive study, demonstrating evidence for clinical efficacy and the lack of safety concerns, clearly supports further development of this exciting new agent that is being studied for the treatment of patients with rheumatoid arthritis," said Larry Moreland, M.D., Professor of Medicine, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham School of Medicine.
"This Phase II study provides strong evidence for clinical activity of the IL-1 Trap in rheumatoid arthritis. Moreover, it appears that we may not yet have achieved the optimal dose level, allowing for the potential of even greater efficacy at higher doses," said Leonard S. Schleifer, M.D., Ph.D., Regeneron's President and Chief Executive Officer. "We plan to move quickly to complete our detailed evaluation of these results and work with Novartis to determine the most efficient path forward for the IL-1 Trap in rheumatoid arthritis. Furthermore, given the favorable safety profile observed, we also intend to pursue a broader clinical development program for this promising molecule in several additional therapeutic categories."
Regeneron and Novartis Pharma AG, who formed a collaborative arrangement to develop and commercialize the IL-1 Trap, indicated that they will be working together to evaluate the data gathered in the study and determine the best path forward for the next clinical study.
Trial Design and Preliminary Data Summary
The multi-center Phase II trial was a randomized, placebo-controlled, double-blind study in people with active RA who have had an inadequate response to at least one disease-modifying anti-rheumatic drug (DMARDs). The study included approximately 200 participants, who were randomized equally into placebo or one of three fixed-dose groups (25, 50, or 100 mg) and received weekly subcutaneous injections. A substantial proportion of the subjects in each group were on DMARDs at baseline and continued their treatment with DMARDs during the trial (65%, 63%, 60%, and 68% of patients in the placebo, 25 mg, 50 mg, and 100 mg groups, respectively). The double-blind treatment period ran for 12 weeks, and participants were evaluated for 10 weeks following the cessation of treatment for safety and to track disease progression. The American College of Rheumatology (ACR20) criteria for improvement in RA as a function of IL-1Trap dose was the pre-specified primary efficacy endpoint. ACR50, ACR70, and ACR-N scores and other measures of disease activity were evaluated as secondary efficacy and exploratory endpoints.
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AI
