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
- Telavant has initiated the TAHOE study, a Phase 2 clinical trial of RVT-3101 for the treatment of moderate to severely active Crohn's disease. The study aims to evaluate the safety and efficacy of RVT-3101 in patients with Crohn's disease, with primary endpoints being clinical remission and endoscopic response at week 14.
- None.
- 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-3101
- Telavant 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 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 (
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
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.
Roivant Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and variations of such words or similar expressions. The words may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act.
Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts, including statements about the clinical and therapeutic potential of our products and product candidates, the availability and success of topline results from our ongoing clinical trials and any commercial potential of our products and product candidates. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements.
Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
Contact
Investors
Roivant Investor Relations
ir@roivant.com
Media
Stephanie Lee
Roivant Sciences
stephanie.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
FAQ
What is the TAHOE study?
What are the primary endpoints of the study?
What is RVT-3101?
What were the results of the Phase 2 trial in ulcerative colitis?
What is the potential impact of RVT-3101 on Crohn's disease patients?
Who is leading the TAHOE study?
