argenx FB102 meets Phase 2 endpoint
- argenx (NASDAQ:ARGX) said its Phase 2 FB102 study in adults with celiac disease met its primary endpoint with a statistically significant result of p=0.0176.
- Secondary tissue and symptom measures were consistent with the primary endpoint, while no new safety signals were identified.
- argenx plans to advance FB102 into Phase 3 development and present detailed Phase 2 data at a future medical meeting.
argenx (NASDAQ:ARGX) said its Phase 2 study of FB102 in adults with celiac disease met its primary endpoint, showing a statistically significant improvement versus placebo at day 78 with a p-value of 0.0176.
The primary endpoint measured change from baseline in villus height-to-crypt depth ratio during a gluten challenge, a measure used to assess changes in the structure of intestinal tissue.
Measures of intestinal immune-cell density, a composite tissue score and patient symptoms were consistent with the primary endpoint, according to argenx.
The company said FB102's safety profile remained consistent with earlier studies and no new safety signals were identified during the Phase 2 trial.
argenx said it plans to move FB102 into Phase 3 development and present detailed Phase 2 findings at an upcoming medical meeting.
The study represents the first clinical readout for FB102 since argenx acquired Forte Biosciences in August 2026, adding the drug candidate to its development pipeline.
FB102 has received FDA Fast Track designation for celiac disease and is also being evaluated for potential use in vitiligo and alopecia areata.
