Wednesday, June 18, 2014

UpdatesPlus - EULAR - 24wk data reported for JAK inhibitor, VX-509 reported in MTX-IR RA patients

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
  • VX-509 is a selective JAK3 inhibitor developed by Vertex with 25- to 150-fold selectivity vs other JAK isotypes
  • The company has publicly commented that it is focusing on its cystic fibrosis activities, waiting for a partner to further develop VX-509
  • Phase 2b data were first presented at ACR with ACR20 reach 70% at 12wks with acceptable DAS28-CRP remission (29%). Safety appears quite good in general although triglyceride levels were elevated considerably (30-40mg/dL)
  • Vertex subsequently presented 24wk data in a Jan 2014 press release
  • These 24wk data were expanded upon at EULAR.  Of note lower doses appeared to accumulate further efficacy between weeks 12 and 24
  • AEs were similar although 2 further serious infections accrued in the 150mg dose.  More dramatic increases in moderate lymphopenia and ALT elevation were observed.  Of concern moderate lymphopenia was observed at a similar rate across the dose range

Comments:  Vertex has also completed a biomarker study and an open label extension study is now closed for enrollment (presumably from the biomarker and Phase 2b studies).  We understand that further studies will not be initiated until a partner is identified or Vertex dedicates internal resources 


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