(RTTNews) – argenx SE (ARGX) said the Phase 3 ADDRESS trial, which evaluated subcutaneous efgartigimod (efgartigimod alfa and hyaluronidase-qvfc) in adults with pemphigus vulgaris and pemphigus foliaceus, did not meet its primary or secondary endpoints.
Pemphigus is a rare group of chronic autoimmune blistering 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 severe pain and an increased risk of infection. Pemphigus vulgaris and pemphigus foliaceous are the most common forms of pemphigus.
The results of the Phase 3 ADDRESS study showed that the percentage of pemphigus vulgaris or PV patients who achieved the primary endpoint of complete remission with a minimal dose of steroids (CRmin) did not differ significantly between efgartigimod efgartigimod subcutaneous and placebo.
Argenx noted that it will not pursue additional development in the pemphigus area and plans to prioritize the clinical development of efgartigimod in the ongoing severe autoimmune indications.
Meanwhile, argenx said it is reviewing the BALLAD study in light of the Phase 3 ADDRESS results and the similar biology between pemphigus and bullous pemphigoid, and has decided not to make a GO/NO GO decision at this time, but rather to wait for everyone’s lessons. currently enrolled patients and consider a new study design for the future.
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