Boston, MA 06/12/2014 (wallstreetpr) – Sanofi SA (ADR) (NYSE:SNY) and Regeneron Pharmaceuticals Inc (NASDAQ:REGN) announced successful results from a Phase III study of experimental drug sarilumab in treating rheumatoid arthritis (RA) in patients who had previously shown no response to methotrexate (MTX) treatment.
The pharmaceutical companies presented their new data which demonstrated that sarilumab is capable of increasing key clinical response rates which are defined as obtaining an ACR70 for a minimum of 24 consecutive week period. It underlined consistent improvements in symptoms and signs of RA after a longer tenure of 52 weeks, which was marked as the secondary endpoint of the study.
Presenting Data at EULAR 2014
The trial, called SARIL-RA-MOBILITY, was previously announced to meet all three critical endpoints and hence exhibiting efficacy in disease symptoms and signs in a period of 24 weeks, physical activity in a period of 16 weeks and slowing down of joint damage advancement in a 52 weeks long period. The companies seek to present the finding at the European League against Rheumatism Annual Congress (EULAR 2014) Congress, which is scheduled to be held in Paris, France.
The SARIL-RA-MOBILITY Phase II study was conducted on 1,197 patients (all adults) having active RA ranging from moderate to severe levels. These patients had shown no response previously to MTX treatment. The subjects were randomly distributed into one of three therapy groups who received subcutaneous dosage every alternate week. The three dosage groups each received one of: placebo, sarilumab 200 milligrams or sarilumab 150 mg, all in combination with MTX. Statistically noticeable results were observed in all three key endpoints in both the sarilumab groups as compared to the results of the placebo group. In addition, both these groups demonstrated significant improvement on chief clinical response secondary endpoint. Another noteworthy finding was that patients of sarilumab groups showed important safety data in consistency with previous experimental trials with the drug.
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