Roivant releases positive RVT-3101 trial results in UC

Switzerland-headquartered Roivant Sciences (Nasdaq: ROIV) saw its shares rise 17% in pre-market trading yesterday, after it announced positive results from the chronic period of the TUSCANY-2 Phase IIb study of RVT-3101, a once-monthly subcutaneously administered anti-TL1A antibody. The stock closed the day still up 8.4% at $2.45.

TUSCANY-2 is a large, global, randomized, double-blind, placebo-controlled dose-ranging Phase IIb 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.