Emvistegrast in ulcerative colitis hits Phase 2 primary endpoint

Emvistegrast in ulcerative colitis met its primary endpoint in the Phase 2 SWIFT study, with 66% of participants on the once-daily 200 mg oral dose reaching clinical response at Week 12, against 37% on placebo.

Week 12 results for emvistegrast in ulcerative colitis

The primary endpoint was clinical response, based on the modified Mayo clinical score. It was reached by 66% (39/59) of participants on emvistegrast 200 mg, against 37% (22/60) on placebo (nominal P <0.001). Clinical remission was 31% (18/59) against 8% (5/60) (nominal P <0.05). Histological Endoscopic Mucosal Improvement was 25% (15/59) against 10% (6/60), and mucosal healing was 24% (14/59) against 10% (6/60), both at nominal P <0.05. Endoscopic improvement was 39% (23/59) against 12% (7/60) (nominal P <0.001).

Adverse events occurred in 86/238 participants, at 36% (64/178) on emvistegrast and 37% (22/60) on placebo, and were largely Grade 2 or lower. Serious adverse events occurred in 4/178 (2%) of participants on emvistegrast and in none on placebo; all were deemed unrelated to study drug. Overall, 3/238 (1%) participants discontinued the study because of adverse events.

Why it matters

The result is a Phase 2 signal, not a confirmed effect. The secondary comparisons are reported as nominal p-values, and the SWIFT study is still ongoing, with maintenance-phase data and further analyses planned. Gilead describes emvistegrast as a potentially differentiated, once-daily oral option and plans a Phase 3 monotherapy study in 2027. Of the participants, 78% were naive to advanced therapies or had not failed any, while 22% had failed one or two. For context on the wider ulcerative colitis field, see tulisokibart in ulcerative colitis and a recent pediatric ulcerative colitis approval.

Source: Gilead Sciences company statement, 19 October 2026