Sanofi, Regeneron arthritis drug meets goals in Phase 3 trial

Reuters

* Trial combined sarilumab and methotrexate

* Sarilumab met all three co-primary endpoints

* Most reported adverse events were infections

PARIS, Nov 22 (Reuters) - An experimental drug forrheumatoid arthritis developed by French drugmaker Sanofi and Regeneron, when combined withmethotrexate, improved symptoms and physical function and slowedprogression of the disease in a late-stage clinical trial.

Rheumatoid arthritis is an autoimmune disease in which thebody's immune system mistakenly attacks healthy tissue, causinginflammation and pain in the joints.

Sanofi and Regeneron's drug, called sarilumab, is aninjectable antibody that works by blocking aninflammation-causing protein called interleukin 6. It is similarto Actemra, Roche's fast-growing treatment approved in2010.

The success of the trial pushes the new drug one step closerto the production line, although it still to pass furtherlong-term trials and the approval process in particular markets.

The 52 week SARIL-RA-MOBILITY Phase 3 trial enrolled some1,200 patients with active, moderate-to-severe rheumatoidarthritis, who have not benefited from or been able to toleratethe standard oral treatment, methotrexate, whose side effectscan include nausea and liver damage.

Patients given a 200 mg dose of sarilumab every other weekon top of methotrexate saw a 66 percent improvement in signs andsymptoms of rheumatoid arthritis after six months, Sanofi andRegeneron said in a statement on Friday.

Those given a 150 mg dose saw a 58 percent improvement,while those given a placebo alongside methotrexate saw a 33percent improvement.

Sarilumab met the other two primary endpoints of the study,improving physical function at week 16 and inhibitingprogression of joint damage after one year, the companies said.

Infections were the most frequently reported adverse sideeffects, as well as increases in "bad" LDL cholesterol andtransaminases, they added.

Sarilumab, alongside cholesterol drug alirocumab, is one ofthe promising products Sanofi is developing under itspartnership with U.S. biotech Regeneron to offset the loss ofpatents on once top-selling drugs like blood thinner Plavix.

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