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Gilead's IBD Drug Shows Promise in Mid-Stage Study
Confirmed
In Short: A mid-stage study found Gilead's emvistegrast eliminated symptoms for patients with ulcerative colitis.
Gilead Sciences announced promising results from a mid-stage study of its drug emvistegrast, which showed significant improvement in patients with moderate to severe ulcerative colitis (UC).
The study, which evaluated three doses of the drug—25 mg, 75 mg, and 200 mg—found that a 200 mg daily dose for 12 weeks resulted in a 23% placebo-adjusted clinical remission rate.
Swati Tole, Gilead’s senior vice president overseeing clinical development of its inflammatory disease medicines, expressed optimism about the drug's potential. She stated, “Emvistegrast has the potential to be a best-in-class oral for patients with ulcerative colitis.”
At week 12, 66% of patients receiving the 200-mg dose of emvistegrast achieved a clinical response, compared with 37% of placebo recipients. Additionally, 31% of patients in the treatment group achieved clinical remission, versus 8% in the placebo group.
The drug also showed positive results in histological endoscopic mucosal improvement, with 25% of patients achieving this measure, which combines improvements in the intestinal lining observed during endoscopy with reductions in inflammation seen in tissue samples.
Endoscopic improvement was noted in 39% of patients receiving the 200-mg dose, compared with 12% of those on placebo. Gilead reported that the drug was generally well tolerated, with mostly grade 2 or lower adverse events reported in 36% of patients across the three emvistegrast dose groups.
Tole added, “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.”
Gilead plans to initiate a Phase 3 monotherapy study in 2027 and sees emvistegrast as a potential backbone for future combination approaches.
The drug works by blocking a pathway that prevents immune cells from migrating into intestinal tissue, thereby reducing chronic inflammation associated with UC.
No journal article matching this report (STAT+: Gilead’s IBD drug eliminated symptoms for patients, mid-stage study finds) was found in the research index, and no page published by the researchers turned up in the search.
Background
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What's confirmed
- Test your knowledge with our new weekday mini crossword An oral treatment from Gilead Sciences eliminated the symptoms experienced by patients with a type of inflammatory bowel disease, mid-stage study results reported Monday that could boost the biotech’s push to develop new drugs for inflammatory and autoimmune conditions.
- A 200 milligram daily dose of the Gilead pill, called emvistegrast, taken for 12 weeks resulted in a 23% placebo-adjusted clinical remission rate for patients with moderate to severe ulcerative colitis, the Phase 2 study showed.
- “Emvistegrast has the potential to be a best-in-class oral for patients with ulcerative colitis,” Swati Tole, Gilead’s senior vice president overseeing clinical development of its inflammatory disease medicines, told STAT on Friday.
What's still developing
- A news rewrite is not the researchers' measurement.
- Gilead reported that 78% of participants were either new to advanced therapies or had not previously experienced treatment failure with one, while 22% had failed one or two advanced therapies.
- Gilead Sciences has notched a phase 2 win in ulcerative colitis (UC), with its once-daily pill emvistegrast outperforming placebo on the study's primary endpoint and setting the stage for a late-stage trial in 2027.