Emvistegrast Phase 2 Success: Bold Oral Colitis Data

Emvistegrast Phase 2 results show that Gilead’s once-daily oral pill met the primary endpoint of the SWIFT study in adults with moderately to severely active ulcerative colitis. Gilead reported on 19 October 2026 that, at week 12, 66% of participants on the 200 mg dose had a clinical response, compared with 37% on placebo. The data were presented as a late-breaking abstract at United European Gastroenterology Week in Barcelona. The study is ongoing, and emvistegrast is investigational and not approved anywhere for this use.

Emvistegrast Phase 2: key takeaways

• At week 12, clinical response was 66% (39 of 59) on emvistegrast 200 mg versus 37% (22 of 60) on placebo, Gilead reports.
• Clinical remission was 31% versus 8% for the same comparison, a secondary endpoint.
• Gilead says adverse events were similar to placebo (36% versus 37%) and discontinuations for adverse events were 1%.
• Gilead plans a Phase 3 monotherapy study in 2027.
• All p-values are nominal, and maintenance data are still to come.

What the SWIFT study tested

According to Gilead’s statement, SWIFT is a Phase 2, randomised, double-blind, placebo-controlled, multicentre, dose-ranging study in adults aged 18 to 75 with moderately to severely active ulcerative colitis, defined as a total modified Mayo score of 5 to 9 with an endoscopic subscore of at least 2. Participants had an inadequate response, loss of response or intolerance to at least one UC treatment, and had tried fewer than three advanced therapy mechanisms. The registry entry for the study (GS-1427) lists the same programme.

Participants were randomised 1:1:1:1 to emvistegrast 200 mg, 75 mg, 25 mg or placebo. In all, 238 people took part, 178 on emvistegrast and 60 on placebo. Gilead says 78% were naive to advanced therapies or had not failed any, and 22% had failed one or two. The first part of the study is a 12-week placebo-controlled induction phase, followed by a maintenance phase to week 52 and a blinded extension to week 116.

The emvistegrast Phase 2 primary endpoint result

The primary endpoint was clinical response at week 12, based on the modified Mayo clinical score. Gilead reports 66% (39 of 59) on the 200 mg dose versus 37% (22 of 60) on placebo, with a nominal p-value below 0.001. By our calculation that is a difference of about 29 percentage points. The statement reports efficacy against placebo only for the 200 mg dose, so we cannot say how the 75 mg and 25 mg doses performed.

Secondary endpoints for emvistegrast Phase 2

Gilead reports the following week 12 comparisons for the 200 mg dose against placebo, all with nominal p-values:

• Clinical remission: 31% (18 of 59) versus 8% (5 of 60).
• Histological endoscopic mucosal improvement: 25% (15 of 59) versus 10% (6 of 60).
• Mucosal healing: 24% (14 of 59) versus 10% (6 of 60).
• Endoscopic improvement: 39% (23 of 59) versus 12% (7 of 60).

Nominal means the p-values have not been adjusted for testing several outcomes, so the secondary results are best read as supportive signals and not as proof.

Safety findings in emvistegrast Phase 2

Across all emvistegrast doses, Gilead reports adverse events in 36% of participants (64 of 178) versus 37% on placebo (22 of 60), most of them grade 2 or lower. Serious adverse events occurred in 4 of 178 (2%) on emvistegrast and none on placebo, and Gilead says all were judged unrelated to the study drug. Three of 238 participants (1%) stopped because of adverse events. Gilead describes the drug as generally well tolerated. With a few hundred participants and 12 weeks of follow-up, rare or longer-term effects cannot be ruled out.

A note on the emvistegrast Phase 2 figures

One passage in Gilead’s statement gives the number of responders on the 200 mg dose as 33 of 59, while the key findings section gives 39 of 59. Only 39 of 59 matches the reported 66%, so we use that figure and treat the other as a probable typographical slip. We flag it so readers can check the company’s final text.

What comes next after emvistegrast Phase 2

Swati Tole, senior vice president of clinical development for inflammation at Gilead, said the company plans to start a Phase 3 monotherapy study in 2027 and sees emvistegrast as a potential backbone for future combination approaches. Prof. Silvio Danese of Vita-Salute San Raffaele University said selectively targeting the α4β7 pathway with an oral therapy may offer a promising new option. Wenjun Ouyang, Gilead’s senior vice president of inflammation research, noted that the drug was discovered and developed internally.

What ulcerative colitis is

General background: the U.S. National Institute of Diabetes and Digestive and Kidney Diseases describes ulcerative colitis as a chronic condition that causes inflammation and sores in the lining of the large intestine. Treatment aims to reduce inflammation and keep symptoms in remission, and an oral option would add to the choices available. Nothing here is medical advice.

Risks and caveats on emvistegrast Phase 2

• Results are from a company statement and a conference abstract, not a peer-reviewed paper.
• Only the 200 mg dose is reported against placebo.
• Maintenance-phase data are not yet available.
• Emvistegrast is investigational, and approval depends on Phase 3 results and regulators.

In our assessment, the emvistegrast Phase 2 data are a credible early signal for an oral treatment in a field where many patients still need new options, but the real test is whether the benefit holds through maintenance and in the larger Phase 3 study. See also Vir Biotechnology Partnership: Bold $1.88B Gilead Deal. More in our pharmaceutical coverage.

What to watch next on emvistegrast Phase 2

• Maintenance results from the SWIFT study.
• Results for the 75 mg and 25 mg doses.
• Design and start of the Phase 3 monotherapy study in 2027.

Frequently asked questions

What is emvistegrast?

An investigational, once-daily oral alpha-4 beta-7 integrin inhibitor from Gilead, also known as GS-1427.

Did it meet its primary endpoint?

Yes. Gilead reports clinical response at week 12 of 66% on 200 mg versus 37% on placebo.

Is it approved?

No. It is investigational and not approved for ulcerative colitis anywhere.

How we reported this: we relied on Gilead’s statement of 19 October 2026, the trial registry and a public health page. Our own calculations and general background are labelled. Last updated: 20 October 2026. This article is news reporting and not medical advice.