ROIV Roivant Sciences Ltd

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 Roivant. “Building on the successful Phase 2 trial in UC, expansion into CD is the next step in applying this unique mechanism to bring solutions and value to the healthcare community.”

Roivant recently reported chronic period data for RVT-3101 from the TUSCANY-2 Phase 2b study in UC, demonstrating improved efficacy from the induction to chronic period. This was the first-ever long-duration data reported for an anti-TL1A antibody. At the expected Phase 3 once-monthly subcutaneous dose in the overall population, RVT-3101 treatment resulted in improved clinical remission (36% at week 56 vs. 29% at week 14) and endoscopic improvement (50% vs. 36%). At the expected Phase 3 once-monthly subcutaneous dose in the biomarker positive population, RVT-3101 treatment resulted in improved clinical remission1 (43% at week 56 vs. 33% at week 14) and endoscopic improvement2 (64% vs. 47%). Across all doses and patient groups, RVT-3101 was well tolerated and showed a favorable safety profile.

About Inflammatory Bowel Disease and Crohn’s Disease

Inflammatory bowel diseases are chronic inflammatory diseases of the gastrointestinal (GI) tract. It is estimated that up to 2 million US adults suffer from inflammatory bowel diseases, which include ulcerative colitis and Crohn's disease. Crohn’s disease is characterized by inflammation in one or more portions of the GI tract, including the mouth, small intestine, or colon, with segments of normal tissue in between. Inflammation in CD can affect all layers of tissue and may lead to fibrosis and obstructions. Therapeutic response to medications varies across patients, and poor prognostic indicators and lack of biomarkers lead to a “trial and error” treatment paradigm. Even the best advanced therapies typically result in 10-15% remission of disease, leaving frequent flare-ups, continued worsening of disease, or serious complications like intestinal fibrosis that may require surgery. Many patients that achieve remission on a therapy will stop responding to it over time, and no approved medication directly addresses the fibrotic component of IBD.

About Telavant

Telavant, a Roivant company, is developing innovative therapies to help patients living with inflammatory and fibrotic diseases. Telavant is developing RVT-3101 as a potential best-in-class and first-in-class subcutaneous therapy in ulcerative colitis and Crohn’s disease, including for patients with a prospectively defined biomarker who may benefit from a precision approach utilizing RVT-3101.

For more information, please visit www.telavanttx.com.

About Roivant

Roivant is a commercial-stage biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Today, Roivant’s pipeline is concentrated in inflammation and immunology and includes VTAMA®, a novel topical approved for the treatment of psoriasis and in development for the treatment of atopic dermatitis; batoclimab and IMVT-1402, fully human monoclonal antibodies targeting the neonatal Fc receptor (“FcRn”) in development across several IgG-mediated autoimmune indications; and RVT-3101, an anti-TL1A antibody in development for ulcerative colitis and Crohn’s disease, in addition to several other therapies in various stages of clinical development. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. For more information, visit www.roivant.com.

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MediaStephanie LeeRoivant Sciencesstephanie.lee@roivant.com

1 Clinical Remission for RVT-3101 is defined as an endoscopic subscore ≤1, ≥1-point decrease from baseline to achieve a stool frequency subscore of ≤1, and rectal bleeding subscore of 0

2 Endoscopic Improvement for RVT-3101 is defined as an endoscopic subscore ≤1