Wednesday, March 27, 2013

Galapagos has announced filing to initiate Phase 2b rheumatoid arthritis program for GLPG0634

Galapagos has announced filing to initiate Phase 2b rheumatoid arthritis program for GLPG0634

  • In its research update call which has just completed, Galapagos has laid out its global Phase 2b RA program for GLPG0634, at the end of which Abbvie has a licensing option
  • Trial protocols for the first studies have been submitted this week. The first patients are expected to be enrolled by the end of the year; primary end-point data are expected early 2015
  • The Darwin program will comprise 3 studies: Darwin1 (MTX add-on); Darwin2 (Monotherapy); Darwin3 (long term extension).
  • Darwin1 and Darwin2 have 12 wk primary end-points with a subsequent 12wk treatment period. The 24wk, not the primary end-point data will trigger Abbvie licensing
  • The program mirrors development of Xeljanz, Baricitinib, VX-509; ASP015K (Galapagos commented that Lilly has not conducted a monotherapy study but it expects this will be done)
  • Darwin1 and Darwin2 are evaluating 50-200mg qd and 25-100mg bid dosing
  • Galapagos also discussed GSK2586184 during the call. This JAK1 candidate is in Phase 2 for psoriasis and SLE. The company confirmed during the Q and A that GSK and Abbvie can look at any indications
Comments: Of note the primary end-point measure was not indicated during the call. Likewise, there were no indications given on secondary end-points and in particular whether any novel measures of biomarkers are being followed. The interaction between GSK2586184 and GLPG0634 remains of interest; both candidates could be developed by different partners (GSK and Abbvie) for the same indications. While this may be good for Galapagos it will be interesting to see how the two will be positioned alongside one another

Selected slides are attached - a transcript and full slide deck should be available through Galapagos' website shortly. We will provide a full analysis in the next issue of UpdatesPlus-Rheumatoid Arthritis


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