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Sanofi and Regeneron Report Positive Phase 2b Trial Results with Sarilumab in Rheumatoid Arthritis
Date:7/12/2011

IL-6 inhibition.  The incidence of serious adverse events among the five sarilumab treatment groups and placebo group were comparable.

Sarilumab also demonstrated significant benefit compared to placebo in secondary endpoints, including ACR 50, ACR 70, and DAS 28 scores, additional measures of clinical activity used in RA trials.  

"Following these encouraging Phase 2b results in rheumatoid arthritis, the companies are currently discussing the dose(s) of sarilumab to advance into the Phase 3 portion of the MOBILITY  trial," said Elias Zerhouni, President, Global Research & Development, Sanofi.

"The MOBILITY results provide evidence that IL-6R blockade with sarilumab represents a promising new anti-inflammatory investigational therapy for reducing RA disease symptoms.  We are very pleased that the first of our novel VelocImmune® derived antibodies is poised to enter Phase 3 development," said George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Research Laboratories.

In the Phase 2b ALIGN trial in ankylosing spondylitis (AS), sarilumab did not demonstrate significant and clinically meaningful improvements in signs and symptoms of active AS compared to placebo in patients who had inadequate response to NSAIDs.  Sarilumab was generally well tolerated. The most common adverse events reported more frequently in active treatment arms included infections and neutropenia.

Full data of both Phase 2b trials will be submitted for presentation at an upcoming scientific conference.

About SarilumabSarilumab (REGN88/ SAR153191) is the first fully human monoclonal antibody directed against the alpha subunit of the IL-6 receptor complex (IL-6R alpha).  Sarilumab is a high affinity, sub-cutaneously delivered, specific inhibitor of IL-6 signaling.  It blocks the binding of IL-6 to its receptor and interrupts the resultant cyto
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SOURCE Regeneron Pharmaceuticals, Inc.
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