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

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Briefings

A Phase 2 study by Gilead Sciences reported that the oral drug emvistegrast, taken daily for 12 weeks, achieved a 23% clinical remission rate in patients with moderate to severe ulcerative colitis. This result, which exceeded Wall Street analyst expectations, was announced by Swati Tole, Gilead's senior vice president for inflammatory disease medicines. The study used a 200-milligram daily dose, and the findings were presented in a mid-stage Phase 2 trial context.

Key points

• A 200-milligram daily dose of emvistegrast achieved a 23% placebo-adjusted clinical remission rate for patients with moderate to severe ulcerative colitis after 12 weeks of treatment.
• The statistically significant improvement in symptom relief exceeded Wall Street analyst expectations for the Phase 2 study.

Context

Swati Tole, Gilead's senior vice president overseeing clinical development of inflammatory disease medicines, stated that while patients with inflammatory bowel disease have other therapies available, a majority still experience persistent symptoms. The study results are significant for Gilead's push to develop new drugs for inflammatory and autoimmune conditions.

Limitations

The evidence is from a mid-stage Phase 2 study, meaning the long-term safety and efficacy of emvistegrast are not yet fully established. The study population consisted of patients with moderate to severe ulcerative colitis, and the 23% remission rate was placebo-adjusted.

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