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Gilead Sciences Reports Positive Phase 2 Trial Results for Oral Bowel Disease Therapy

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Gilead Sciences (NASDAQ:GILD) reported positive results from a mid-stage clinical trial evaluating its experimental drug emvistegrast in adults with moderate to severe ulcerative colitis. In the 12-week Phase 2 SWIFT study, 66% of patients receiving a daily 200 mg dose of emvistegrast achieved a clinical response, compared with 37% of those on placebo. Furthermore, 31% of treated patients reached clinical remission, compared to 8% in the control group.

The once-daily pill was generally well tolerated by trial participants. Side effects occurred in 36% of emvistegrast recipients, while serious adverse events affected 2%, with none attributed to the drug itself. Only 1% of participants discontinued the study due to adverse events. The successful trial positions emvistegrast as a promising oral option for inflammatory bowel conditions, expanding the drugmaker's portfolio beyond its core viral therapies.

Following these mid-stage findings, Gilead Sciences plans to initiate a late-stage monotherapy trial for the treatment in 2027. Investors will be monitoring further regulatory progress and study timelines as the therapy advances toward potential commercialization.

Key points

  • Gilead Sciences Phase 2 trial of oral emvistegrast achieved a 66% clinical response rate compared to 37% for placebo in ulcerative colitis patients.
  • Clinical remission was reached by 31% of patients on emvistegrast, versus 8% in the placebo group over 12 weeks.
  • The once-daily drug was well tolerated, with drug-related serious adverse events at 0% and a 1% dropout rate due to side effects.
  • Gilead Sciences plans to begin Phase 3 monotherapy testing for the treatment in 2027.

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Questions and answers

What were the Phase 2 trial results for Gilead Sciences ulcerative colitis drug?

In a 12-week Phase 2 trial, 66% of ulcerative colitis patients taking 200 mg of emvistegrast achieved a clinical response compared to 37% on placebo, while 31% reached clinical remission versus 8% on placebo.

When will Gilead Sciences start Phase 3 trials for emvistegrast?

Gilead Sciences expects to begin a late-stage monotherapy trial for emvistegrast in 2027.