Teva and Sanofi Announce Accelerated Timeline for Anti-TL1A Phase 2b Program in Patients with Inflammatory Bowel Disease

Rhea-AI Summary

Teva Pharmaceuticals and Sanofi have announced an accelerated timeline for their anti-TL1A Phase 2b program in inflammatory bowel disease (IBD) patients. The RELIEVE UCCD trial, investigating duvakitug for moderate-to-severe ulcerative colitis (UC) and Crohn's disease (CD), has completed patient enrollment earlier than expected due to rapid recruitment. As a result, topline results for both UC and CD are now anticipated in Q4 2024, with detailed results to be presented in 2025. This acceleration replaces the previously planned interim analysis for the second half of 2024. Teva and Sanofi are collaborating to co-develop and co-commercialize duvakitug, potentially a best-in-class IBD treatment.

Positive

• Accelerated patient enrollment in Phase 2b trial
• Earlier availability of topline results (Q4 2024)
• Potential for best-in-class IBD treatment
• Collaboration between Teva and Sanofi for co-development and co-commercialization

Negative

• None.

Medical Research Analyst

The accelerated enrollment in the RELIEVE UCCD Phase 2b trial for duvakitug (anti-TL1A) is a significant development in the inflammatory bowel disease (IBD) treatment landscape. This acceleration suggests strong interest from both patients and clinicians, potentially indicating a high unmet need in the IBD space.

The earlier availability of topline results, now expected in Q4 2024 for both ulcerative colitis (UC) and Crohn's disease (CD), could provide Teva and Sanofi with a competitive advantage in the race to bring new IBD treatments to market. This is particularly noteworthy given that duvakitug is being positioned as a potentially best-in-class treatment for IBD.

From a research perspective, the decision to forego the interim analysis initially planned for the second half of 2024 in favor of full topline results is intriguing. This suggests the companies' confidence in the trial's progress and potentially in the drug's efficacy. However, it's important to note that this decision also means we'll have to wait longer for any indicative data on the drug's performance.

The collaboration between Teva and Sanofi on this project combines Teva's expertise in generics and specialty medicines with Sanofi's strong presence in immunology. This partnership could potentially lead to a more robust development and commercialization strategy for duvakitug.

Investors should keep a close eye on the Q4 2024 results, as positive outcomes could significantly impact both companies' positions in the lucrative IBD market, estimated to reach $31.94 billion globally by 2030. However, it's important to remember that Phase 2b results, while important, are not definitive and the path to market still involves the critical Phase 3 trials.

Financial Analyst

The accelerated timeline for Teva and Sanofi's anti-TL1A program represents a potentially significant catalyst for both companies. Early completion of patient enrollment suggests strong interest in the trial, which could translate to faster market adoption if the drug proves successful.

From a financial perspective, this acceleration could have several implications:

• Reduced R&D costs: Faster enrollment typically leads to lower per-patient costs and overall trial expenses.
• Earlier potential revenue stream: If successful, duvakitug could hit the market sooner than initially anticipated, providing a boost to both companies' top lines.
• Competitive advantage: Being first-to-market or among the first with a novel mechanism of action can lead to significant market share capture.

However, investors should be cautious. While the accelerated timeline is promising, it doesn't guarantee positive results or regulatory approval. The IBD market is highly competitive, with established players like AbbVie's Humira and newer entrants like Pfizer's Xeljanz.

For Teva, success in this program could help diversify its portfolio beyond generics and its flagship multiple sclerosis drug, Copaxone. For Sanofi, it could strengthen its position in immunology, complementing its existing portfolio.

The co-development and co-commercialization agreement between Teva and Sanofi spreads both risk and potential reward. Investors should consider how this might impact each company's financials, including revenue recognition and profit-sharing arrangements.

In conclusion, while this news is certainly positive, its true financial impact won't be clear until we see the topline results in Q4 2024. Investors should monitor this program closely but maintain a balanced view of its potential impact on either company's valuation.

• Enrollment acceleration drives earlier-than-anticipated data availability for this potentially best-in-class IBD treatment
• Topline results for both UC and CD now anticipated in Q4 2024
• Teva and Sanofi are collaborating to co-develop and co-commercialize duvakitug (anti-TL1A) for moderate-to-severe ulcerative colitis (UC) and Crohn’s disease (CD) patients

PARSIPPANY, N.J. & PARIS--(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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1. What is inflammatory bowel disease (IBD)? Centers for Disease Control and Prevention. 2022. Available at: https://www.cdc.gov/ibd/what-is-IBD.htm. Accessed July 2024.
2. McDowell, C., Farooq, U., & Haseeb, M. (2020). Inflammatory Bowel Disease (IBD). PubMed; StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK470312/. Accessed July 2024.
3. Dharni, K., Singh, A., Sharma, S. et al. Trends of inflammatory bowel disease from the Global Burden of Disease Study (1990-2019). Indian Journal of Gastroenterology (2023). https://doi.org/10.1007/s12664-023-01430-z.
4. A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease (RELIEVE UCCD) https://clinicaltrials.gov/study/NCT05499130?term=TEV-48574&rank=2. Accessed July 2024.
5. A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease. https://clinicaltrials.gov/study/NCT05668013?term=TEV-48574&rank=1. Accessed July 2024.

 

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IR Contacts

Ran Meir +1 (267) 468-4475

Yael Ashman +972 (3) 914 8262

Sanjeev Sharma +1 (973) 658 2700

PR Contacts

Kelley Dougherty +1 (973) 832-2810

Eden Klein +972 (3) 906 2645

Source: Teva Pharmaceutical Industries Limited

FAQ

What is the new timeline for Teva and Sanofi's anti-TL1A Phase 2b trial results for IBD?

Teva and Sanofi now anticipate topline results for both ulcerative colitis and Crohn's disease in Q4 2024, with detailed results to be presented in 2025.

Why has the timeline for Teva's (TEVA) duvakitug trial been accelerated?

The timeline has been accelerated due to significant acceleration in patient recruitment, leading to early completion of patient enrollment in the RELIEVE UCCD Phase 2b trial.

What conditions is Teva's (TEVA) duvakitug being developed to treat?

Duvakitug is being developed to treat moderate-to-severe ulcerative colitis (UC) and Crohn's disease (CD), which are forms of inflammatory bowel disease (IBD).

How are Teva (TEVA) and Sanofi collaborating on the duvakitug program?

Teva and Sanofi are collaborating to co-develop and co-commercialize duvakitug for moderate-to-severe ulcerative colitis and Crohn's disease patients.