The Amsterdam biotech said an independent data monitoring committee recommended stopping the UNITY study, testing subcutaneous efgartigimod (Vyvgart) in adults with moderate-to-severe Sjögren’s disease, after an interim analysis concluded it could not meet its primary endpoint. No new safety signals were identified, and the company said it will analyze the data in depth after database lock. The setback follows Novartis’s positive ianalumab results last year in a disease Bernstein analysts called one of the hardest in immunology to run trials in.
The same morning, Argenx announced positive Phase 2 topline results for FB102, a CD122 inhibitor in adults with celiac disease undergoing a gluten challenge: the study met its primary endpoint of change from baseline in the villus height-to-crypt depth ratio at day 78 versus placebo (p=0.0176), and the company plans to advance it to Phase 3. It is the first clinical readout of FB102 since Argenx acquired Forte Biosciences for $2.2 billion in August. Shares fell 18% in European morning trading Thursday, wiping out their gains for the year to date, Morningstar reported.