Argenx (ARGX) will discontinue a phase 3 study of efgartigimod subcutaneous in adults with moderate-to-severe Sjogren's disease after an independent data monitoring committee recommended stopping the trial for futility, the company said Thursday.
The committee concluded that the study was unable to meet its primary endpoint, while safety remained consistent with efgartigimod's established profile, according to the company.
Separately, Argenx said a phase 2 study of FB102 in adults with celiac disease met its primary endpoint, showing a "statistically significant and clinically relevant" treatment effect, compared with placebo.
The observed safety profile was consistent with previous studies and the known safety profile of FB102, with no new safety signals identified. The company plans to advance FB102 into phase 3 development, it said.
Sjogren's disease is a chronic, slowly progressive, inflammatory systemic autoimmune disease characterized by destruction of the exocrine glands. Celiac disease is a chronic autoimmune condition that can lead to impaired nutrient absorption.
Argenx shares were down nearly 17% in premarket activity.