An oral treatment from Gilead Sciences has hit its mark in a mid stage ulcerative colitis trial, STAT reported on October 19. A 200 milligram daily dose of emvistegrast, taken for 12 weeks, produced a 23 percent placebo adjusted clinical remission rate in patients with moderate to severe ulcerative colitis. STAT said the improvement was statistically significant and exceeded Wall Street analyst expectations. The STAT headline described the condition as IBS; the trial population, per the body of its report, is inflammatory bowel disease, specifically ulcerative colitis.
Emvistegrast (GS-1427) is an oral selective alpha4beta7 integrin inhibitor, in effect the gut selective mechanism of Takeda’s injectable Entyvio reformulated as a pill. Blocking alpha4beta7 stops lymphocytes trafficking to the gut, which is why the class is valued for efficacy without broad immunosuppression. Gilead has been studying the drug in the Phase 2 SWIFT trial, with the readout flagged since August as a key test of the company’s push to diversify beyond virology.
“Emvistegrast has the potential to be a best-in-class oral for patients with ulcerative colitis,” Swati Tole, Gilead’s senior vice president for clinical development of its inflammatory disease medicines, told STAT. “Patients with inflammatory bowel disease, while they have other therapies available, still have persistent symptoms. A majority do not achieve remission, so seeing these data was encouraging for us.”
The discipline on this story is sourcing. The result was reported by STAT from an interview and its own account of the data; Gilead had issued no release carrying the figures by the time of this edition, and no second outlet had independently published the remission rate. The 23 percent figure is therefore carried as STAT reported it, flagged here and graded C, and the fuller dataset, including endoscopic outcomes, safety and the lower dose arms, remains to come when Gilead or a conference presentation puts the numbers on the record.