Wednesday, June 18, 2014

UpdatesPlus - EULAR 2014 - Further positive Phase 3 data were reported yesterday for Sanofi/Regeneron's sarilumab

The alert below is from our EULAR 2014 coverage.  We have captured most of the key oral and poster presentations delivered at EULAR and will be analyzing these more comprehensively in upcoming issues of our UpdatesPlus service.  UpdatesPlus is a service comprising alerts and monthly reports including pipeline and trial updates plus analysis of key information.  The service is designed for industry and academics across the immunology & Inflammation spectrum.  To register for UpdatesPlus or to get further information please contact

  • Sarilumab is, like (Ro)actermra an IL-6R mAb.  Sarilumab is differentiated in that it is fully human leading some to expect improved AEs/reduced AADs
  • Sarilumab has been investigated in the Phase 3 SARIL-RA-MOBILITY study in rheumatoid arthritis
  • MTX-IR patients were randomized to sarilumab (150 or 200mg) or placebo all at q2w sc administration in combination with MTX
  • Sanofi/Regeneron reported in 2013 that the 3 co-primary end points, ACR20 (24wks); HAQ-DI (16wks) and mTSS (52wks) had been met.  Our analysis from UpdatesPlus, Dec 2013 is shown below, reporting Sarilumab data at 200mg q2w from SARIL-RA-MOBILITY alongside Brevacta data (with placebo data reported in parentheses)

  • New data presented at EULAR on Thursday included improvement in major clinical response (ACR70 for >24wks) from 3% to 15% (ACR70 kinetic curves are shown below left).  Durable ACR20 rates were also reported with efficacy maintained to 52wks (below right)

  • Further data were reported in a poster on Thursday, describing that Sarilumab reduced levels of type1 collagen breakdown products (C1M, C2M and C3M).  This effect was rapid and seen within 2wks

Comments:  SARIL-RA-MOBILITY is the first of 5 Sarilumab Phase 3 studies to read out.  Sanofi has previously indicated a filing date of mid 2015.  The durable response along with major clinical response in some patients is promising, as is the reduction in radiographic progression.  The biomarker study is particularly interesting in this context as these molecules are produced upon joint destruction.  Nordic Bioscience is developing an assay to measure C1M/C2M/C3M and we understand that the ability of this assay to predict joint structure outcome is being evaluated in Phase 3 sarilumab studies. Should predictability be established, we believe that this would confer a significant advantage on Sarilumab in terms of cost effectiveness and the ability to help ensure appropriate treatments are delivered to the patients ahead of those less likely to be effective


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