- Roivant Sciences ROIV announced results from the induction period of the TUSCANY-2 Phase 2b study of RVT-3101 (previously PF-06480605), a once-monthly anti-TL1A antibody for ulcerative colitis.
- The data exhibited statistically significant and clinically meaningful efficacy results at each dose tested. RVT-3101 was well tolerated and showed a favorable safety profile.
- At the dose the company plans to take into a pivotal trial, 31% of patients receiving RVT-3101 achieved disease remission at 12 weeks, compared with 12% of patients in the placebo arm.
- Among patients with the biomarker, 40% achieved remission compared with 10% on placebo.
- Similar but non-statistically significant results were seen in biomarker-positive patients treated with standard-of-care drugs.
- Roivant obtained RVT-3101 from Pfizer Inc PFE and spun it into a new “vant,” though Pfizer opted to take a 25% equity stake in the venture rather than cash.
- The Vant will have the right to enter into an agreement for global development with a 50/50 cost share and co-commercialization rights with Pfizer before Phase 2 (expected in 2025).
- Price Action: ROIV shares are up 8.81% at $7.78 during the premarket session on the last check Wednesday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Loading...
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in