) and partner
Regeneron Pharmaceuticals, Inc.
) 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.
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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
) 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
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
Stocks that look better placed at present include
Isis Pharmaceuticals, Inc.
), which carries a Zacks Rank #2 (Buy).