Roivant-Pfizer ulcerative colitis therapy shines in mid-stage trial

Jan. 4, 2023

Roivant Sciences announced positive results from the induction period of a phase 2b study testing what the drugmaker is calling a "potential best-in-class and first-in-class" subcutaneous therapy for ulcerative colitis.

RVT-3101 (previously PF-06480605) is a once monthly subcutaneously administered anti-TL1A antibody. Last month, Pfizer and Roivant came together to form a new subsidiary to develop and commercialize the drug, which was originally discovered by Pfizer.

TUSCANY-2 is a 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. According to Roivant, 32% of all patients achieved clinical remission and 40% achieved endoscopic improvement. Results were even better for patients who were biomarker positive and biologic-experienced: 41% achieved clinical remission and 56% achieved endoscopic improvement.

The new treatment targets both inflammatory and fibrotic pathways by inhibiting TL1A, which has been shown to modulate the location and severity of inflammation and fibrosis by stimulating TH1 and TH17 pathways, in addition to activating fibroblasts. This means that RVT-3101 has the potential to provide greater efficacy by hitting multiple inflammatory pathways as well as fibrotic pathways.

RVT-3101 will now progress into registrational studies, says Roivant.