Thursday, August 21, 2014

Alert: UpdatesPlus-Psoriasis - Lilly reports impressive Phase 3 data for ixekizumab

This alert comes from our UpdatesPlus-Psoriasis servicea regular analysis providing depth information on all key recent events in the area.  To receive further information or instruction on how to access the service please contact [for a summary of our most recent full report click here]
  • Lilly has reported superiority of ixekizumab to Enbrel and to placebo in the company's UNCOVER program
  • UNCOVER comprises 3 studies: UNCOVER-1 (placebo controlled) and UNCOVER-2 and -3 (placebo and Enbrel controlled)
  • All primary and key secondary measures were met, including superiority to etanercept
  • At 12wks PASI75 rates ranged from 78-90%, while 31-41% of patients achieved PASI100 (complete skin clearance)
  • Improvements in skin clearance were reported within 1wk
  • Lilly has indicated that it plans to file H1 2015
  • AEs were reportedly comparable to etanercept

Comments:  Few have doubted that ixekizumab would generate impressive PASI100 data given previously reported results from across the IL-17 class.  As a point of reference PASI100 rates recently reported for secukinumab were 24-29% at the highest dose tested (300mg qw for 4wk followed by q4w doses).  We presume that the 41% referred to in the Lilly press release relates to the higher dose of ixekizumab (80mg q2w).  In this instance ixekizumab efficacy appears nominally higher than secukinumab although the usual cautions of cross study comparison apply.  Lilly's success will depend in part on speed of response - Novartis has specifically reported this (see Langley et al linked to above) and it will be interesting to see similar data from the UNCOVER program.  Lilly reports efficacy from 1wk however further analysis is obviously required to establish speed of response.  One advantage of ixekizumab is that at the higher dose, just one injection is required.  This contrasts with secukinumab where two injections are required.  Just how much of an impact this will have in terms of injection site reaction and patient convenience remains to be seen.  The profile of the autoinjectors being developed for the two candidates will impact on this.  A further differentiators that Lilly will likely use is the ability to reduce dosing frequency to q12w in some patients after the initial 12wks of treatment.  The feasibility of this approach remains unknown as further data from after the initial 12wks of treatment is awaited


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