Teva and Sanofi Announce Accelerated Timeline for Anti-TL1A Phase 2b Program in Patients with Inflammatory Bowel Disease
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.
Teva Pharmaceuticals e Sanofi hanno annunciato una tempistica accelerata per il loro programma anti-TL1A di fase 2b nei pazienti affetti da malattie infiammatorie intestinali (IBD). Lo studio RELIEVE UCCD, che indaga sul duvakitug per la colite ulcerosa (UC) da moderata a grave e la malattia di Crohn (CD), ha completato il reclutamento dei pazienti prima del previsto grazie a una rapida assunzione. Di conseguenza, i risultati preliminari per sia UC che CD sono ora attesi nel Q4 2024, con risultati dettagliati che verranno presentati nel 2025. Questa accelerazione sostituisce l'analisi intermedia precedentemente programmata per la seconda metà del 2024. Teva e Sanofi stanno collaborando per co-sviluppare e co-commercializzare il duvakitug, potenzialmente un trattamento di punta per l'IBD.
Teva Pharmaceuticals y Sanofi han anunciado un cronograma acelerado para su programa anti-TL1A de fase 2b en pacientes con enfermedad inflamatoria intestinal (IBD). El ensayo RELIEVE UCCD, que investiga el duvakitug para la colitis ulcerosa (UC) moderada a grave y la enfermedad de Crohn (CD), ha completado el reclutamiento de pacientes antes de lo esperado gracias a una rápida captación. Como resultado, se anticipan los resultados preliminares para UC y CD en el Q4 de 2024, con resultados detallados que se presentarán en 2025. Esta aceleración reemplaza el análisis intermedio previamente planificado para la segunda mitad de 2024. Teva y Sanofi están colaborando para co-desarrollar y co-comercializar el duvakitug, que potencialmente podría ser un tratamiento de primera clase para la IBD.
테바 제약과 사노피는 염증성 장질환 (IBD) 환자에 대한 항-TL1A 2b상 프로그램의 가속화된 일정을 발표했습니다. 중등도에서 중증의 궤양성 대장염(UC) 및 크론병(CD)을 연구하는 RELIEVE UCCD 시험이 빠른 환자 모집으로 예상보다 빨리 환자 등록을 완료했습니다. 그 결과 UC와 CD 모두에 대한 주요 결과는 이제 2024년 4분기에 예상됩니다, 2025년에 상세 결과가 발표될 예정입니다. 이 가속화는 2024년 후반에 예정된 중간 분석을 대체합니다. 테바와 사노피는 duvakitug를 공동 개발 및 공동 상용화하기 위해 협력하고 있으며, 이는 IBD 치료를 위한 최고 수준의 치료제가 될 가능성이 있습니다.
Teva Pharmaceuticals et Sanofi ont annoncé un calendrier accéléré pour leur programme anti-TL1A de phase 2b chez des patients atteints de maladies inflammatoires de l'intestin (IBD). L'essai RELIEVE UCCD, qui étudie le duvakitug pour la colite ulcéreuse (UC) modérée à sévère et la maladie de Crohn (CD), a complété le recrutement des patients plus tôt que prévu grâce à un recrutement rapide. En conséquence, des résultats préliminaires pour les UC et CD sont maintenant attendus au quatrième trimestre 2024, avec des résultats détaillés devant être présentés en 2025. Cette accélération remplace l'analyse intermédiaire précédemment prévue pour la seconde moitié de 2024. Teva et Sanofi collaborent pour co-développer et co-commercialiser le duvakitug, qui pourrait potentiellement être un traitement de référence pour l'IBD.
Teva Pharmaceuticals und Sanofi haben einen beschleunigten Zeitrahmen für ihr anti-TL1A-Phase-2b-Programm bei Patienten mit entzündlichen Darmerkrankungen (IBD) angekündigt. Die RELIEVE UCCD-Studie, die duvakitug bei moderat bis schwerer Colitis ulcerosa (UC) und Morbus Crohn (CD) untersucht, hat die Patientenrekrutierung aufgrund einer schnellen Rekrutierung früher als erwartet abgeschlossen. Infolgedessen wird nun mit den vorläufigen Ergebnissen für sowohl UC als auch CD im Q4 2024 gerechnet, während die detaillierten Ergebnisse 2025 präsentiert werden sollen. Diese Beschleunigung ersetzt die zuvor geplante Zwischenanalyse für die zweite Hälfte von 2024. Teva und Sanofi arbeiten zusammen, um duvakitug gemeinsam zu entwickeln und zu vermarkten, möglicherweise eine erstklassige Behandlung für IBD.
- 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
- None.
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
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
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
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
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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- 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.
- 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.
- 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.
- 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.
- 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
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Source: Teva Pharmaceutical Industries Limited
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