Argenx’s FB102 meets primary endpoint in phase 2 celiac trial, paving way for pivotal study

Argenx reported that its experimental antibody FB102 achieved a statistically significant improvement in villus height‑to‑crypt depth (Vh:Cd) compared with placebo in a phase 2 study of adults with celiac disease who underwent an oral gluten challenge. The primary endpoint was met at Day 78, indicating the drug can protect intestinal tissue from gluten‑induced damage.

The data were generated in 126 participants and were presented alongside a composite measure, VCIEL, which combined Vh:Cd with an inflammation marker and was described as consistent with the primary result. The trial builds on earlier phase 1b work in vitiligo and phase 1 data in celiac disease that were part of the rationale for Argenx’s $2.2 billion acquisition of Forte Biosciences.

Analysts had been watching the study closely after Teva’s TEV'408 also succeeded in a phase 2a celiac trial using the same Vh:Cd endpoint. Argenx’s positive readout reinforces confidence that FB102 could advance to a pivotal trial, potentially positioning it as a competitor in the emerging celiac therapeutic space.

The company said the next step is to design a larger, pivotal study to confirm these findings and support regulatory discussions. If successful, FB102 could become a new treatment option for patients with celiac disease who continue to experience symptoms despite a gluten‑free diet.