PARIS (dpa-AFX) - Regeneron Pharmaceuticals Inc. (REGN) and French drug maker Sanofi (SNYNF, SNY) announced Thursday positive topline results from phase 3 studies with Sarilumab in patients with rheumatoid arthritis.
The companies noted that a phase 3 study of sarilumab, an investigational, fully human IL-6 receptor antibody, met its co-primary efficacy endpoints of a greater improvement in signs and symptoms of rheumatoid arthritis or RA at 24 weeks and physical function at 12 weeks, compared to placebo.
Sarilumab is the first fully human monoclonal antibody directed against the IL-6 receptor. Sarilumab was developed using Regeneron's VelocImmune antibody technology.
The study, called SARIL-RA-TARGET, evaluated the efficacy and safety of two subcutaneous sarilumab doses versus placebo, added to non-biologic disease modifying anti-rheumatic drugs therapy in RA patients who were inadequate responders to or intolerant of TNF-alpha inhibitors.
The most frequently reported adverse events included infections and injection site reactions. Serious infections were uncommon. Reduction in neutrophil count was the most common lab abnormality. No unexpected safety findings were observed.
Two additional trials from the Phase 3 program, SARIL-RA-EASY and SARIL-RA-ASCERTAIN, also met their primary endpoints.
Detailed results from all three SARIL-RA trials will be presented at future medical congresses.
The investigational agent is currently under clinical development, and its safety and efficacy have not been evaluated by any regulatory authority. U.S. regulatory submission is planned for fourth quarter in 2015.
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