Roivant Sciences Ltd (NASDAQ:ROIV) released results from the chronic period of the TUSCANY-2 Phase 2b study of RVT-3101 in adult patients with moderate to severe ulcerative colitis.
The company says this is the first-ever long-duration data reported for an anti-TL1A antibody.
Also Read: Roivant Sciences Highlights Topline Data From Atopic Dermatitis Drug In Patients As Young As 2 Years.
Key efficacy analyses from the induction period were measured at week 14, while outcomes for the chronic period were measured at week 56.
For all patients receiving the expected Phase 3 dose in both periods:
- 36% achieved clinical remission at week 56 (compared with 29% at week 14).
- 50% showed endoscopic improvement at week 56 (compared with 36% at week 14).
- 21% achieved endoscopic remission at week 56 (compared with 11% at week 14).
For patients with a prespecified biomarker receiving the expected Phase 3 dose in both periods:
- 43% achieved clinical remission at week 56 vs. 33%.
- 64% showed endoscopic improvement vs. 47%.
- 36% achieved endoscopic remission vs. 13%.
RVT-3101 demonstrated sustained efficacy across a broad dose range measured at 56 weeks. It was well-tolerated with no impact of immunogenicity on clinical efficacy or safety results.
Price Action: ROIV shares are up 13.00% at 10.76 on the last check Thursday.
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