ROIV - Roivant reports positive mid-stage data for ulcerative colitis therapy
- U.K.-based biotech Roivant Sciences ( NASDAQ: ROIV ) announced Wednesday that its Phase 2b trial for subcutaneous ulcerative colitis therapy RVT-3101 generated statistically significant and clinically meaningful efficacy results at each dose level.
- The 52-week TUSCANY-2 trial involved 245 adult participants with moderate to severe ulcerative colitis who received different doses of RVT-3101 against a placebo during the 12-week induction period.
- The induction period indicated clinical remission and endoscopic improvement in 32% and 40% of all subjects, respectively, with similar results at the expected Phase 3 dose.
- For the patients, at the expected Phase 3 dose, who had been treated with biologics and were positive for a biomarker, the clinical remission and endoscopic improvement rates stood at 41% and 56%, respectively.
- RVT-3101 was found to be safe and well tolerated across all doses and patient groups, the company said.
- The 40-week chronic therapy period during which all patients received RVT-3101 is currently underway, with data expected in H1 2023.
- In December, Roivant ( ROIV ) announced an agreement with Pfizer ( NYSE: PFE ) to establish a company focused on developing RVT-3101.
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Roivant reports positive mid-stage data for ulcerative colitis therapy