PARSIPPANY, N.J. & PARIS / Jul 25, 2024 / Business Wire / Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and Sanofi today announced an update to the timing for the anti-TL1A, duvakitug (formerly known as TEV-’574/SAR447189) program investigating the human IgG1-λ2 monoclonal antibody targeting TL1A for moderate-to-severe IBD.
Patient enrollment in the RELIEVE UCCD (ulcerative colitis and Crohn’s disease) Phase 2b trial has completed early due to significant acceleration in patient recruitment. As a result, Teva and Sanofi now anticipate having topline results for both UC and CD in Q4 2024, and detailed results will be presented in a scientific forum in 2025. This adjustment replaces the previously planned interim analysis for the second half of 2024, which will not be conducted. Teva and Sanofi are collaborating to co-develop and co-commercialize duvakitug for moderate-to-severe UC and CD patients.
About the Collaboration
On October 3, 2023, Teva and Sanofi entered into an exclusive collaboration to co-develop and co-commercialize Teva’s duvakitug (anti-TL1A) for the treatment of UC and CD, two types of IBD. Under the terms of the agreement, in partial consideration of licenses granted to Sanofi, Teva received an upfront payment of $500 million shortly after closing and may receive up to $1 billion in development and launch milestones. Each company will equally share the remaining development costs globally and net profits and losses in major markets, with other markets subject to a royalty arrangement. Sanofi will lead the development of the Phase 3 program. Teva will lead commercialization of the product in Europe, Israel and specified other countries, and Sanofi will lead commercialization in North America, Japan, other parts of Asia and the rest of the world.
About Inflammatory Bowel Disease
Inflammatory bowel disease (IBD) is a chronic autoimmune disorder characterized by chronic inflammation of the gastrointestinal (GI) tract. The two main types of IBD are ulcerative colitis (UC) and Crohn’s disease (CD).1 UC and CD are chronic inflammatory conditions of the GI tract characterized by repetitive cycles of relapses and remission. Prolonged inflammation can lead to damage within the GI tract, including fibrosis, a common complication of IBD characterized by an excessive accumulation of scar tissue in the intestinal wall, which may cause narrowing and obstruction. Common symptoms of both conditions include persistent diarrhea, rectal bleeding, abdominal pain, loss of appetite, and weight loss. There is currently no cure for IBD – the goal of treatment is to induce and maintain remission and prevent flares.2 Globally, approximately 4.9 million cases of IBD have been identified, with incidence rising in several regions.3
About RELIEVE UCCD
RELIEVE UCCD is a 14-week Phase 2b, randomized, double-blind, dose-ranging study to determine the pharmacokinetics, efficacy, safety, and tolerability of duvakitug (anti-TL1A) in adults with ulcerative colitis (UC) or Crohn's disease (CD). In the trial, patients who meet pre-specified inclusion criteria are randomized to subcutaneously receive either one of two duvakitug (anti-TL1A) dose regimens or placebo in a 1:1:1 ratio (stratified by diagnosis [UC or CD] and previous exposure to advanced IBD therapy [biologics and small molecules]) for 14 weeks. Participants who complete the 14-week induction period have the option to enter the long-term extension (LTE), consisting of a 44-week maintenance period for responders and a re-induction period for non-responders. Primary efficacy endpoints for both the 14-week and 44-week LTE study are number of participants with moderate-to-severe UC who show clinical remission (as defined by the modified Mayo score) and the number of participants with moderate-to-severe CD who show an endoscopic response (as defined by the endoscopic score for CD). The trial includes sites in the U.S., Canada, Europe, and Asia.4,5
About Duvakitug (Anti-TL1A)
Duvakitug (anti-TL1A) is a potential best-in-class human IgG1-λ2 monoclonal antibody that targets tumor necrosis factor (TNF)-like ligand 1A (TL1A), also known as TNF superfamily member 15 (TNFSF15). TL1A signaling is believed to amplify inflammation and drives fibrosis associated with inflammatory bowel disease (IBD); thus, targeting TL1A with duvakitug may mitigate the over-active immune response in these conditions. Duvakitug (anti-TL1A) is currently in Phase 2b clinical trials for the treatment of ulcerative colitis (UC) and Crohn's disease (CD), two types of inflammatory bowel disease. The safety and efficacy of duvakitug (anti-TL1A) have not been reviewed by any regulatory authority.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global pharmaceutical leader with a category-defying portfolio, harnessing our generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicines. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its 37,000 employees across 58 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes of millions of patients every day. To learn more about how Teva is all in for better health, visit www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully compete in the marketplace, including our ability to achieve expected results from investments in our product pipeline including to successfully develop and commercialize our duvakitug (anti-TL1A, TEV’574) asset for the treatment of ulcerative colitis and Crohn’s disease, two types IBD; our exclusive collaboration with Sanofi; the risk that we will incur significant costs in connection with the development of anti-TL1A (duvakitug), which may exceed any revenue generated by duvakitug (anti-TL1A); risks that regulatory approvals and other requirements may delay the development and commercialization of our duvakitug (anti-TL1A); our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to sustain and focus our portfolio of generics medicines; and other factors discussed in our Quarterly Report on Form 10-Q for the first quarter of 2024 and in our Annual Report on Form 10-K for the year ended December 31, 2023, including in the section captioned “Risk Factors.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
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December 23, 2024 November 25, 2024 | |
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