ROIV - Roivant rises after long-term data for ulcerative colitis candidate

2023-06-22 08:32:13 ET

Roivant Sciences ( NASDAQ: ROIV ) added ~12% pre-market Thursday after the U.K.-based biotech announced long-term data from a Phase 2b trial for its once-monthly subcutaneous therapy, RVT-3101, targeted at ulcerative colitis.

Citing 56-week data from the 245-patient TUSCANY-2 trial, Roivant ( ROIV ) said that the anti-TL1A antibody at the expected Phase 3 dose led to a 36% clinical remission compared to 29% at Week 14.

As for about 60% of patients who tested positive for a biomarker identified in its previous Phase 2a TUSCANY study, the clinical remission stood at 43% at Week 56 compared to 33% at Week 14.

The global trial involving adults with moderate to severe ulcerative colitis comprised an induction period and a chronic period. While the induction phase included a placebo arm, all patients received RVT-3101 during the chronic period.

The drug was well tolerated throughout 56 weeks across all doses, Roivant ( ROIV ) noted.

In December, Pfizer ( PFE ) joined hands with a subsidiary of Roivant ( ROIV ) to obtain commercial rights for RVT-3101 for markets outside the U.S. and Japan.

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