Gilead’s emvistegrast delivered greater clinical response than placebo, setting up the asset for Phase 3 testing in ulcerative colitis as well as studies in other inflammatory diseases and bolstering the company’s push beyond its HIV portfolio.
Gilead Sciences’ investigational drug emvistegrast delivered higher response rates versus placebo in a Phase 2 study of ulcerative colitis—findings that analysts at BMO Capital Markets say “validate” the pharma’s efforts to diversify beyond HIV and into immunology and inflammation.
“Gilead’s asset looks highly competitive vs other a4b7 agents,” BMO wrote in a note on Monday. The group pointed to Eli Lilly’s zotemtegrast and Takeda’s Entyvio, which similarly block the a4b7 integrin in order to suppress inflammation in the gut.
In the mid-stage SWIFT trial, 238 patients with moderately to severely active ulcerative colitis were randomly assigned to receive 200 mg, 75 mg or 25 mg of oral emvistegrast daily or placebo. Results, presented Monday at the 2025 United European Gastroenterology Week in Barcelona, Spain, showed that 66% of patients on the highest dose of emvistegrast achieved clinical response, compared to 37% of patients on placebo.
The treatment benefit was nominally significant, meeting the study’s primary endpoint. Clinical response rates for the 75-mg and 25-mg doses of emvistegrast were 51% and 43%, respectively, according to Gilead’s presentation at the conference.
With these data, Gilead plans to take emvistegrast into late-stage development—a Phase 3 study set to start next year—with an eye toward future emvistegrast combination therapies, said Swati Tole, senior vice president of Clinical Development, Inflammation, in a prepared statement.
Gilead is also looking to launch a Phase 2b/3 study of the asset in Crohn’s disease, noted BMO, which also flagged the company’s plans to test emvistegrast in combination with other assets, both internal and external, for inflammatory bowel disease.
“Taken together, we view SWIFT as an incremental positive for Gilead’s inflammatory strategy that establishes emvistegrast as a credible oral a4b7 option,” the analysts wrote.
Like BMO, analysts at Truist Securities “view the 200 mg cohort results as competitive,” they told investors on Monday. However, the firm pointed out that “dose response is not perfect,” particularly in terms of secondary endpoints. Rates of clinical remission, for instance, reached 31% in the highest dose group, but came out to 9% and 20% in the 75-mg and 25-mg arms, respectively. Remission in placebo was 8%.
A similar pattern emerged for the other secondary endpoints—including mucosal healing, endoscopic improvement and histologic endoscopic mucosal improvement—with “75 mg underperforming 25 mg,” Truist explained. Gilead chalked up the lack of a dose response effect to “potential study noise” and small treatment arm sizes, the analysts wrote after speaking with Tole and other members of the Gilead team. The pharma hasn’t yet provided a mechanistic explanation for this discrepancy, Truist flagged.
“Despite an uneven dose response, we see the data as encouraging clinical POC [proof of concept] for emvistegrast and another step in GILD’s broader I&I ambitions,” Truist noted. Indeed, Gilead’s business is heavily reliant on its HIV portfolio, which in the second quarter accounted for $5.7 billion of the company’s total $7.8 billion sales.
Seeking to diversify, Gilead has recently struck multiple deals beyond its infectious disease comfort zone. In February, for instance, the pharma dropped $7.8 billion to swallow its CAR T collaborator Arcellx ahead of a key decision for the partners’ investigational multiple myeloma therapy anitocabtagene autoleucel (anito-cel). The asset is under review with a decision expected by Dec. 23.
Other pickups in Gilead’s diversification drive this year include the inflammatory biotech Ouro Medicines and the antibody-drug conjugate (ADC) developer Tubulis, with which the bigger company had previously partnered and which will operate as an ADC specialist under the Gilead umbrella. Gilead last week also secured an equity stake in Vir Biotechnology, giving its vote of confidence to the biotech’s T cell engager platform. The pharma put up to $1.74 billion on the line in milestones, and in return received three dual-masked T cell engagers that it plans to study for solid tumors.
