STAT+: Gilead’s IBD drug eliminated symptoms for patients, mid-stage study finds — SkimNews

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- Emvistegrast, Gilead's once-daily oral treatment, achieved a 23% placebo-adjusted clinical remission rate at a 200mg dose over 12 weeks in moderate-to-severe ulcerative colitis patients in a Phase 2 study.
- The Phase 2 results, reported Monday, were statistically significant and exceeded Wall Street analyst expectations, per the source.
- Swati Tole, Gilead's SVP overseeing clinical development of inflammatory disease medicines, told STAT the drug "has the potential to be a best-in-class oral for patients with ulcerative colitis."
- Gilead framed the unmet need by noting that a majority of inflammatory bowel disease patients do not achieve remission on existing therapies and continue to experience persistent symptoms.
- The mid-stage readout supports Gilead's broader effort to expand into new inflammatory and autoimmune disease treatments beyond its established portfolio.
Why it matters: Gilead's 23% placebo-adjusted remission rate beat analyst forecasts for a mid-stage oral ulcerative colitis candidate, strengthening the company's competitive position in the inflammatory disease space where most patients still don't achieve remission on current therapies. A positive Phase 2 sets up potential pivotal trials against entrenched injectable biologics like Humira and Remicade.
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