Sanofi (SNY) and partner Regeneron Pharmaceuticals, Inc. (REGN) recently announced that they started enrolling patients for two phase III trials (SARIL-RA COMPARE and SARIL-RA ASCERTAIN) on their rheumatoid arthritis (:RA) candidate, sarilumab.
The 24-week, multi-center, randomized, double-blind and active-calibrator SARIL-RA ASCERTAIN study (n = 200) will evaluate the safety and efficacy of sarilumab and Actemra (tocilizumab) in combination with methotrexate (MTX) in patients with RA who received inadequate treatment benefit from tumor necrosis factor alpha (TNF-alpha) inhibitors.
Meanwhile, the multi-center, randomized, double-blind and active-control SARIL-RA COMPARE trial will assess the safety and efficacy of sarilumab in combination with MTX versus Amgen Inc.’s (AMGN) Enbrel (etanercept). The trial will enroll 700 patients suffering from moderate-to-severe RA who demonstrated an insufficient response to Humira (adalimumab) as first TNF-alpha inhibitor treatment.
We note that Sanofi and Regeneron are conducting a SARIL-RA phase III development program to evaluate the use of sarilumab in the RA indication. The program consists of five trials, namely, SARIL-RA MOBILITY, SARIL-RA TARGET, SARIL-RA COMPARE, SARILRA ASCERTAIN and SARIL-RA EXTEND.
SARIL-RA MOBILITY, the most advanced phase III trial in the SARIL-RA program, has enrolled 1,197 patients. The data from the trial is expected to be released in the first half of 2014.
Sanofi carries a Zacks Rank #3 (Hold). Sanofi is looking to combat the generic threat confronting most of its key drugs by signing deals and making acquisitions. We are pleased with Sanofi’s efforts to develop its pipeline and believe that newly approved products in Sanofi’s portfolio hold huge commercial potential.
Stocks that look better placed at present include Isis Pharmaceuticals, Inc. (ISIS), which carries a Zacks Rank #2 (Buy).
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