Phase 3 Cimzia program opens in psoriasis

• UCB’s sales of Cimzia continue to expand rapidly with YoY growth reaching 28%. Q3 2014 sales were approx $263M
• Unlike other TNFis, Cimzia approval in  dermatology has been limited to psoriatic arthritis however in these patients RAPID reported promising skin improvement.  Likewise, Phase 2 efficacy in psoriasis patients was high with PASI75 rates of 75% reported
  
• Prompted by these data and a need to expand indications to maximize sales, UCB licensed Cimzia to Dermira in 2014 for development in psoriasis.  The license is for the US, Canada and the EU
• Dermira will be responsible for Phase 3 development costs and will receive payments of up to $49.5 million on the achievement of development and regulatory milestones
• Dermira and UCB filed a Phase 3 IND in Sept 2014 and the Phase 3 CIMPASI program has now been announced
  
• CIMPASI-I and CIMPASI-II will each randomize 225 patients to placebo or Cimzia (400mg, q2w, sc).  In one arm patients will be switched to 200mg at week 6, a dosing regimen similar to that approved for psoriatic arthritis.  The primary endpoints will be PASI75 and PGA 0/1 at 16wks.  The primary endpoints will be reached in Q1 2016
  

Comments:  The UCB/Dermira agreement represents a logical move, allowing Dermira to extend from it's traditionally topical approach and for UCB to expand into dermatology where it has limited experience.  Developing Cimzia for psoriasis will however face the obvious challenge of competing with new high efficacy drug classes including the IL-17 mAbs and IL-23 mAbs from 2016 onwards.  It will be interesting to see how this challenge is addressed.  Cimzia has previously been positioned around speed and predictability of response, although of note Cosentyx (Secukinumab) is also remarkable in its speed of response.  Clarification of the CIMPASI study design is required and in particular dose strength after 6wks.  In one arm the dose is reduced to 200mg q2w (similar to the current label for psoriatic arthritis).  It is unclear if the dose strength in the second arm is maintained at 400mg q2w - if this is the case the dose is higher than that currently approved and may have been selected to produce higher efficacy.



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