- 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.
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