Roivant Sciences Ltd. announced positive results from the induction period of the TUSCANY-2 Phase 2b study of RVT-3101 (previously PF-06480605), a once monthly subcutaneously administered anti-TL1A antibody which demonstrated statistically significant and clinically meaningful efficacy results at each dose tested. RVT-3101 was well tolerated and showed a favorable safety profile. RVT-3101 will progress into registrational studies as a potential best-in-class and first-in-class subcutaneous therapy in ulcerative colitis.

TUSCANY-2 is a large, global, randomized, double-blind, placebo-controlled dose-ranging Phase 2b study to investigate the efficacy, safety, and pharmacokinetics of RVT-3101 in 245 adult participants with moderate to severe ulcerative colitis. TUSCANY-2 is a 52-week study, with a 12-week induction period comparing different doses of RVT-3101 against placebo, and a 40-week chronic therapy period during which all subjects receive RVT-3101. The chronic therapy period is still ongoing with data expected in 1H 2023.

During the induction period, patients were treated monthly with subcutaneous RVT-3101 at 50 mg, 150 mg, and 450 mg without a loading dose required. RVT-3101 demonstrated statistically significant and clinically meaningful efficacy at each dose tested. These results demonstrated best-in-indication potential for RVT-3101 across the full population of moderate to severe ulcerative colitis patients, with enhanced efficacy in patients who were positive for a prospectively defined biomarker regardless of prior biologic experience.

RVT-3101 has the potential to be both a highly efficacious first- or second-line treatment and a preferred precision medicine in the approximately 60% of patients who are biomarker positive.