Roivant Sciences reports chronic period data for RVT-3101 from TUSCANY-2 study

Roivant Sciences announced results from the chronic period of the TUSCANY-2 Phase 2b study of RVT-3101, a once-monthly subcutaneously administered anti-TL1A antibody. 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 adult participants with moderate to severe ulcerative colitis. TUSCANY-2 is a 56-week study in which the key efficacy analyses from the induction period comparing different doses of RVT-3101 against placebo were measured at week 14. Key outcomes for the chronic period, in which all patients received RVT-3101, were measured at week 56. Patients who received RVT-3101 in the induction period were preassigned to receive either the same or a lower dose in the chronic period. Roivant reported positive data for the induction period of the study in January 2023. The results from the chronic period of TUSCANY-2 are as follows: For all patients receiving the expected Phase 3 dose in both the induction and chronic periods: 36% Clinical Remission at week 56; 50% Endoscopic Improvement at week 56; 21% Endoscopic Remission at week 56. For patients who tested positive for a prespecified biomarker and received the expected Phase 3 dose in both the induction and chronic periods: 43% Clinical Remission at week 56; 64% Endoscopic Improvement at week 56; 36% Endoscopic Remission at week 56. Safety profile: Well-tolerated through 56 weeks across all doses with no impact of immunogenicity on clinical efficacy or safety results. These results continue to support RVT-3101’s potential as a first-in-class anti-TL1A antibody, demonstrating sustained efficacy across a broad dose range measured at 56 weeks. At the expected Phase 3 dose, RVT-3101 offers improved efficacy results. These results were further enhanced in the roughly 60% of patients selected by a prospectively defined biomarker which had been identified in the earlier Phase 2a TUSCANY study.