Argenx Reports Mixed Pipeline Update With Positive Celiac Data; Ends Sjögren's Phase 3 Study
(RTTNews) - argenx SE (ARGX), a global immunology company, provided updates on two clinical programs, reporting positive Phase 2 results for FB102 in celiac disease while discontinuing the Phase 3 UNITY study of efgartigimod SC in Sjögren's disease.
FB102 is an investigational anti-CD122 antibody being developed for autoimmune diseases, including celiac disease, vitiligo and alopecia areata. In the Phase 2 FB102-301 study, the treatment met its primary endpoint, showing a statistically significant improvement in the ratio of villus height-to-crypt depth (Vh:Cd) at Day 78 versus placebo during a controlled gluten challenge (p=0.0176).
Additional efficacy measures, including intraepithelial lymphocyte density, VCIEL composite score and symptoms, were consistent with the primary endpoint. The safety profile was consistent with previous studies, with no new safety signals identified.
Based on the Phase 2 results, argenx plans to advance FB102 into Phase 3 development. Detailed results are expected to be presented at an upcoming medical meeting.
Separately, argenx said it will discontinue the Phase 3 UNITY study evaluating efgartigimod SC in adults with moderate-to-severe Sjögren's disease following an Independent Data Monitoring Committee recommendation to stop the trial for futility.
The IDMC concluded that the UNITY study was unable to meet its primary endpoint of change from baseline in systemic disease activity, measured by the clinical EULAR Sjögren's Syndrome Disease Activity Index at Week 48. Safety remained consistent with the established profile of efgartigimod, with no new safety signals identified.
argenx said it will conduct a comprehensive analysis of the UNITY data following study close and database lock to generate insights that could inform future research in Sjögren's disease.
Efgartigimod is a neonatal Fc receptor (FcRn) blocker marketed as VYVGART and VYVGART Hytrulo for approved autoimmune indications, including generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy.
ARGX has traded between $661.85 and $1,072.75 over the past year.
The stock closed Wednesday's trading at $928.44, down 0.22%.
In pre-market trading the stock is at $784.78, down 15.47%.
