Tuesday, August 05, 2014

UpdatesPlus-Psoriasis alert - Guselkumab moves into Phase 3 development

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 full report please contact fiona.watts@leaddiscovery.co.uk [for a summary of our most recent full report click here]

  • Both studies will compare Guselkumab (100mg sc), adalimumab and placebo
  • Guselkumab will be injected at wks 0, 4 and q8w.  VOYAGE 2 will include a treatment withdrawal protocol
  • Co-primary endpoints are IGA 0/1 and PASI90 at 16wks
  • Key secondary endpoints include nail and scalp psoriasis scores
  • VOYAGE 2 will include additional psychiatric QoL scores (ie SF-36, anxiety)
  • 1750 patients will be enrolled in total from Q3 2014 with the primary endpoint date expected in Sept-Oct 2015
  • Patients will be recruited in Taiwan, Germany and Poland

Comments:  Phase 2b data reported from X-PLORE at AAD earlier this year demonstrated superior efficacy of Guselkumab vs adalimumab.  This study evaluated q8w and q12wk dosing.  At q8w, 100mg was the highest dose investigated and continuation at this dose in VOYAGE is consistent with the benign AE profile in X-PLORE.  Of note, 3 MACE events were reported, but after 28wks and in patients with at least 3 CV risk factors.  q12w dosing (200mg) was investigated in X-PLORE but this did not appear to improve efficacy over 100mg q8w.  Advancing q8w rather than q12w dosing does place Guselkumab at a slight disadvantage to Stelara although this is likely to be of limited importance.  Of greater interest perhaps is how Janssen intends to differentiate Guselkumab and Stelara.  Stelara targets the shared p40 subunit of IL-12/23 while Guselkumab targets p19 and therefore offer more selective blockade of IL-23.  The biological implications of this remain unclear although further Phase 3 studies are inevitable and these may shed light on the relative positioning of the two Janssen products.   For example, does Janssen believe Guselkumab may provide improved efficacy and therefore conduct a head to head vs Stelara, or could Guselkumab carry a reduced risk of infectious and therefore conduct a study in a high risk cohort?  The former could create internal competition between the two Janssen products and we therefore doubt this strategy would be followed.  The latter is also questionable given the low rate of infection with Stelara in long-term studies. Differentiation of Guselkumab and Stelara therefore remains unclear.  Also unclear is why the CTG entry indicates that multiple sites have withdrawn from VOYAGE studies - whether this is a temporary issue and what the reasons are require further understanding


Blogger Unknown said...


Due to the way Janssen Research & Development, LLC uploads information into clinicaltrials.gov, study sites evaluated by Janssen R&D but eventually not selected for participation in the clinical trials are characterized in the clinicaltrials.gov posting as “withdrawn”.

This characterization has no impact on the guselkumab Phase 3 clinical development program, which remains on track for initiation later this year.



Brian Kenney
Senior Director, Global Immunology & Biotechnology
Pharmaceutical Communication & Public Affairs
Janssen Research & Development

1:21 PM  

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