Gilead colitis pill beats placebo in mid-stage trial
Gilead's once-daily pill emvistegrast put 31% of ulcerative colitis patients into remission at 12 weeks, compared with 8% on placebo, Fierce Biotech reported. Gilead plans a larger, late-stage trial in 2027, Fierce Biotech and Endpoints News reported. The pill could one day compete with Takeda's injected drug Entyvio.
Gilead Sciences' experimental once-daily pill emvistegrast beat a placebo in a phase 2 trial in ulcerative colitis, a chronic inflammatory bowel disease, Fierce Biotech and Endpoints News reported. Gilead plans to start a late-stage trial next year, both Fierce Biotech and Endpoints News reported.
At week 12, 31% of patients on the 200-milligram dose reached clinical remission, compared with 8% on placebo, Fierce Biotech reported, citing an October 19 company release. About 66% of patients on that dose had a clinical response, compared with 37% on placebo, Fierce Biotech reported.
The Swift trial enrolled 238 adults with moderately to severely active disease and tested three doses, Fierce Biotech reported. The results were presented at United European Gastroenterology Week in Barcelona, Fierce Biotech reported.
The drug blocks a protein called α4β7 integrin, which helps steer certain immune cells to the gut, Fierce Biotech reported. Blocking it is meant to keep those cells from moving into the bowel lining, where they can drive inflammation, Fierce Biotech reported.
The drug was generally well tolerated, with mostly mild or moderate side effects reported in 36% of patients across the three dose groups, compared with 37% on placebo, Fierce Biotech reported. Serious side effects occurred in 2% of patients on the drug, none linked to treatment, Fierce Biotech reported.
"We plan to initiate a Phase 3 monotherapy study in 2027," said Swati Tole, a Gilead senior vice president, Fierce Biotech reported. Analysts at Evercore ISI called the results "the strongest datasets ever for a monotherapy in UC," Fierce Biotech reported.
Emvistegrast could eventually challenge Takeda's Entyvio, an antibody that targets the same pathway but is given by infusion or injection, Fierce Biotech reported. Endpoints News reported that the pill posted stronger remission rates than Entyvio, though Fierce Biotech noted that larger trials are needed before comparisons with approved drugs can be drawn. Questions remain about how long the benefit lasts and how the drug works in harder-to-treat patients, Fierce Biotech reported.
What we know: Gilead's pill beat placebo at 12 weeks in a 238-patient trial, and a phase 3 study is planned for 2027.
What we don't: Whether the benefit lasts and how the pill compares with Entyvio in a direct trial.
Where outlets agree Fierce Biotech and Endpoints News report that Gilead's oral drug emvistegrast succeeded in a phase 2 ulcerative colitis trial and that Gilead plans a late-stage study.
Where they differ Endpoints News reported that the pill posted stronger remission rates than Entyvio, while Fierce Biotech said larger trials are needed before such comparisons can be drawn.