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Telavant, a Roivant Company, Advances Inflammatory Bowel Disease Program with First Patient Dosed in Global Phase 2 Trial of Novel Anti-TL1A Antibody RVT-3101 in Crohn’s Disease
The Phase 2 TAHOE study, which is currently enrolling, evaluates the safety and efficacy of RVT-3101 in patients with moderate to severely active Crohn’s
About this update from Roivant Sciences Ltd.
[{"type":"text","content":"The Phase 2 TAHOE study, which is currently enrolling, evaluates the safety and efficacy of RVT-3101 in patients with moderate to severely active Crohn’s disease (CD)Roivant recently announced highly favorable results from the TUSCANY-2 Phase 2b study in ulcerative colitis (UC), demonstrating improved efficacy from the induction to maintenance period of treatment with RVT-3101Telavant plans to initiate a Phase 3 inflammatory bowel disease (IBD) program in patients with moderate to severely active UC NEW YORK and BASEL, Switzerland, July 27, 2023 (GLOBE NEWSWIRE) -- Telavant, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics to help patients living with inflammatory and fibrotic diseases, announced today the initiation of the TAHOE study, a Phase 2 clinical trial of RVT-3101 for the treatment of moderate to severely active CD, with first patient dosed. The TAHOE study (NCT05910528) is a global, randomized, double-blind study evaluating two doses of RVT-3101 given once-monthly in patients with moderate to severely active Crohn’s disease. The primary and key secondary endpoints are the proportion of participants achieving clinical remission by Crohn's Disease Activity Index (CDAI) and the proportion of participants achieving endoscopic response at week 14. “We are excited to broaden the potential of RVT-3101 with the initiation of the TAHOE Phase 2 study as we believe its novel mechanism of action, addressing both inflammation and fibrosis, can make a significant impact on patients suffering with Crohn’s disease,” said Bittoo Kanwar, Chief Medical Officer of Telavant. “We look forward to evaluating RVT-3101’s potential to address the high unmet need that exists in this patient population.” “Despite the availability of multiple treatment options, many Crohn’s disease patients do not achieve adequate disease control,” said Professor Geert D'Haens, gastroenterologist and investigator at Amsterdam UMC. “TL1A provides a compelling therapeutic target to treat inflammatory bowel diseases and the IBD community is excited about the potential for RVT-3101 as a new treatment approach for UC and CD patients.” “This is an exciting milestone for Telavant as we continue to expand the opportunities for RVT-3101,” said Frank Torti, Chief Executive Offer of Telavant and Vant Chair at Roiva...