Argenx : Phase 3 Study Of Efgartigimod SC In Pemphigus Fails To Meet Primary & Secondary Endpoints

(RTTNews) - argenx SE (ARGX) said that the phase 3 ADDRESS study, which evaluated efgartigimod subcutaneous (efgartigimod alfa and hyaluronidase-qvfc) in adults with pemphigus vulgaris and pemphigus foliaceus, did not meet primary or secondary endpoints.

Pemphigus is a rare group of chronic blistering autoimmune diseases that affect the skin and mucous membranes, and are characterized by painful blisters, erosions and acantholysis, or disruption of keratinocyte adhesion. Blisters often break open, causing serious pain and increased risk of infection. Pemphigus vulgaris and pemphigus foliaceous are the most common forms of pemphigus.

The Phase 3 ADDRESS study results showed the proportion of pemphigus vulgaris or PV patients achieving the primary endpoint of complete remission on a minimal dose of steroids (CRmin) was not significantly different between efgartigimod efgartigimod subcutaneous and placebo.

Argenx noted that it will not pursue additional development in pemphigus and plans to prioritize clinical development of efgartigimod in its ongoing severe autoimmune indications.

Meanwhile, argenx said it is reviewing the BALLAD study in light of the Phase 3 ADDRESS results and the comparable biology between pemphigus and bullous pemphigoid, and has decided not to make a GO/NO GO decision at this time but rather wait for learnings from all currently enrolled patients and consider a new trial design for the path forward.

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