Teva and Sanofi Current New Constructive Section 2b Research Outcomes at ECCO 2025 Reinforcing Greatest-in-Class Potential of Duvakitug (Anti-TL1A) in Ulcerative Colitis and Crohn’s Illness

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Teva internet hosting investor name Monday, February 24 at 8:00 a.m. U.S. ET

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• New detailed information from the RELIEVE UCCD research assist total efficacy and security of duvakitug in all pre-specified subgroups throughout the completely different doses
• New endpoints offered embody findings on medical and endoscopic outcomes and histological- endoscopic mucosal enchancment
• Findings to kind the premise for a Section 3 program, anticipated to begin in H2 2025

PARSIPPANY, N.J. and PARIS, Feb. 22, 2025 (GLOBE NEWSWIRE) — Teva Prescribed drugs, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Sanofi right this moment offered new, detailed outcomes from the RELIEVE UCCD Section 2b research of duvakitug (TEV’574/SAR447189), a human IgG1-λ2 monoclonal antibody focusing on TL1A, for the remedy of moderate-to-severe ulcerative colitis (UC) and Crohn’s illness (CD), the 2 most typical types of inflammatory bowel illness (IBD). These outcomes have been shared in two oral shows on the twentieth Congress of the European Crohn’s and Colitis Organisation (ECCO) in Berlin, Germany.^{1, 4}

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Ulcerative colitis

Within the UC cohort of the RELIEVE UCCD research, 36% (450 mg dose) and 48% (900 mg dose) of sufferers handled with duvakitug achieved the first endpoint of medical remission (mMS)* at week 14 in comparison with 20% handled with placebo; placebo-adjusted charges have been 16% (450 mg) and 27% (900 mg) (p=0.050 and 0.003, respectively)^.1-3

As well as, increased medical remission charges have been noticed for each doses of duvakitug versus placebo in each superior remedy (AT)-experienced and AT-naïve subgroups of sufferers.

• AT-experienced: 29% (450 mg) and 36% (900 mg), with placebo-adjusted charges of twenty-two% (450 mg) and 29% (900 mg).
• AT-naïve: 39% (450 mg) and 53% (900 mg), with placebo-adjusted charges of 12% (450 mg) and 26% (900 mg).^1-3

Further endpoints noticed*:

• Scientific response (mMS): 81% (450 mg) and 70% (900 mg) in comparison with 52% handled with placebo.
• Endoscopic enchancment (MES): 45% (450 mg) and 50% (900 mg) in comparison with 23% handled with placebo.
• Histological-endoscopic mucosal enchancment (HEMI): 30% (450 mg) and 33% (900 mg) in comparison with 16% handled with placebo.^1-3

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“Sufferers, a lot of whom have spent years in a recurring cycle of remission and relapse, have been ready a very long time for higher choices in treating ulcerative colitis. We’re extremely inspired by the numerous remedy response, in comparison with placebo seen within the research, each in superior remedy naïve-and skilled sufferers,” stated Walter Reinisch, MD, PhD, Medical College of Vienna, and lead investigator of the RELIEVE UCCD research. “With this potential of duvakitug to cut back irritation, we might actually rework remedy for sufferers with IBD in a secure method.”

Crohn’s illness

Within the CD cohort of the RELIEVE UCCD research, 26% (450 mg) and 48% (900 mg) of sufferers with CD handled with duvakitug achieved the first endpoint of endoscopic response (SES-CD)* in comparison with 13% on placebo; placebo-adjusted charges have been 13% (450 mg) and 35% (900 mg) at week 14 (p=0.058 and &LT0.001, respectively).

As well as, increased endoscopic response charges have been noticed for each doses of duvakitug versus placebo in each AT-experienced and -naïve subgroups of sufferers.

• AT-experienced: 11% (450 mg) and 48% (900 mg), with placebo-adjusted charges of seven% (450 mg) and 44% (900 mg).
• AT-naïve: 47% (450 mg) and 47% (900 mg), with placebo-adjusted charges of 25% (450 mg) and 25% (900 mg).^2-4

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Further endpoints noticed:

• Endoscopic remission (SES-CD): 17% (450 mg) and 26% (900 mg) in comparison with 9% handled with placebo.
• Scientific remission (CDAI): 50% (450 mg) and 54% (900 mg) in comparison with 41% handled with placebo.
• Scientific response (CDAI): 61% (450 mg) and 62% (900 mg) in comparison with 41% handled with placebo.
• Scientific response (PRO2): 50% (450 mg) and 53% (900 mg) in comparison with 29% handled with placebo.^2-4

“Each day, I see sufferers with Crohn’s illness who proceed to endure from the often-severe signs of the illness regardless of obtainable therapies,” stated Vipul Jairath, MBChB, DPhil, FRCP, FRCPC, Professor of Drugs within the Departments of Drugs, Epidemiology and Biostatistics at Western College, and lead investigator of the RELIEVE UCCD research. “The endoscopic response charges seen on this research assist the potential of duvakitug as an efficient new possibility for these who’re in determined want of reduction.”

RELIEVE UCCD security information abstract

In each the UC and CD cohorts, duvakitug was typically nicely tolerated with no emergent security alerts noticed.^1-4 No dose dependent or adversarial occasion (AE) sample was noticed for treatment-related AEs, critical adversarial occasions (SAEs), AEs resulting in discontinuation or adversarial occasions of particular curiosity (AESIs).

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Duvakitug is at present underneath medical investigation, and its efficacy and security haven’t been evaluated by any regulatory authority.

Teva Investor Name
Teva will maintain an investor name and stay webcast on Monday, February 24, 2025, at 8:00 a.m. ET. In the course of the convention name, Eric Hughes, MD, PhD, Govt Vice President of World R&D and Chief Medical Officer, and exterior IBD key opinion leaders (KOLs) will talk about new information offered for duvakitug (Anti-TL1A) constructive Section 2b outcomes on the twentieth Annual Congress of the European Crohn’s and Colitis Group (ECCO). With the intention to take part, please register upfront right here to acquire an area or toll-free cellphone quantity and your private pin. A stay webcast of the decision will even be obtainable on Teva’s web site at: https://ir.tevapharm.com/Occasions-and-Displays. Following the conclusion of the decision, a replay of the webcast will likely be obtainable inside 24 hours on Teva’s web site.

About Inflammatory Bowel Illness  

UC and CD, the 2 essential sorts of IBD, are power inflammatory situations of the GI tract leading to debilitating and protracted signs reminiscent of belly ache, diarrhea, rectal bleeding, fatigue and weight reduction.^5,6 Extended irritation can result in harm throughout the GI tract, together with fibrosis, a standard complication of IBD characterised by an accumulation of scar tissue within the intestinal wall, which can trigger narrowing and obstruction typically requiring hospitalization and surgical procedure. There may be at present no remedy for IBD – the purpose of remedy is to induce and keep remission and forestall flares.⁷ 

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In regards to the RELIEVE UCCD Section 2b Research

RELIEVE UCCD was a 14-week Section 2b, randomized, double-blinded, dose-ranging research to find out the efficacy, security, pharmacokinetics, and tolerability of duvakitug in adults with moderate-to-severe ulcerative colitis (UC) or Crohn’s illness (CD). The research was an progressive and environment friendly basket research design permitting the inclusion of sufferers with both sort UC and CD. Additionally it is the primary and solely randomized, blinded and placebo-controlled Section 2 research to research the influence of TL1A in CD.

Within the research, sufferers who met pre-specified inclusion standards have been randomized to obtain one among two duvakitug doses or placebo, administered each two weeks subcutaneously, in a 1:1:1 ratio for every indication (UC or CD) stratified by earlier publicity to superior IBD therapies [yes (either biologics/small molecule) or no] for 14 weeks. The UC cohort comprised adults with reasonably to severely energetic illness with insufficient response, lack of response or intolerance to earlier standard and/or superior therapies (ATs). The CD cohort comprised adults with reasonably to severely energetic illness with documented insufficient response, lack of response or intolerance to traditional and/or superior therapies (ATs).

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Main efficacy endpoints are the variety of contributors who present medical remission (as outlined by the modified Mayo rating) within the UC cohort or the variety of contributors who present endoscopic response (as outlined by the SES-CD endoscopic rating for CD) within the CD cohort. The research consists of websites within the U.S., Europe, Israel, and Asia.^2,3

About Duvakitug

Duvakitug is a possible best-in-class human IgG1-λ2 monoclonal antibody that targets tumor necrosis issue (TNF)-like ligand 1A (TL1A), often known as TNF superfamily member 15 (TNFSF15). TL1A signaling is believed to amplify irritation and drive fibrosis related to inflammatory bowel illness (IBD) by means of binding its receptor, dying receptor 3 (DR3).

Duvakitug is uniquely designed to inhibit preferentially TL1A signaling by way of DR3, with the potential benefit of diminished TL1A-DcR3 inhibition.⁸

Duvakitug is at present in a Section 2b medical research for the remedy of ulcerative colitis (UC) and Crohn’s illness (CD), the 2 most typical sorts of IBD. The protection and efficacy of duvakitug haven’t been reviewed by any regulatory authority.

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In regards to the Teva and Sanofi Collaboration

Teva and Sanofi are collaborating to co-develop and co-commercialize Teva’s duvakitug for the remedy of UC and CD. Every firm will equally share the event prices globally, and the web earnings and losses in main markets, with different markets topic to a royalty association. Sanofi will lead the Section 3 medical improvement program. Teva will lead commercialization of the product in Europe, Israel and specified different nations, and Sanofi will lead commercialization in North America, Japan, different elements of Asia and the remainder of the world.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a unique type of international pharmaceutical chief, one which operates throughout the complete spectrum of innovation to reliably ship medicines to sufferers worldwide. For over 120 years, Teva’s dedication to bettering well being has by no means wavered. Right now, the corporate’s international community of capabilities allows its 37,000 workers throughout 57 markets to advance well being by creating medicines for the long run whereas championing the manufacturing of generics and biologics. If sufferers have a necessity, we’re already working to handle it. To be taught extra about how Teva is all in for higher well being, go to www.tevapharm.com. ​ 

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About Sanofi

We’re an progressive international healthcare firm, pushed by one objective: we chase the miracles of science to enhance folks’s lives. Our workforce, the world over, is devoted to reworking the follow of medication by working to show the not possible into the potential. We offer probably life-changing remedy choices and life-saving vaccine safety to thousands and thousands of individuals globally, whereas placing sustainability and social accountability on the middle of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY.

Cautionary Be aware Relating to Ahead-Wanting Statements

This press launch incorporates forward-looking statements throughout the which means of the Non-public Securities Litigation Reform Act of 1995, that are based mostly on administration’s present beliefs and expectations and are topic to substantial dangers and uncertainties, each identified and unknown, that would trigger our future outcomes, efficiency or achievements to vary considerably from that expressed or implied by such forward-looking statements. You’ll be able to establish these forward-looking statements by means of phrases reminiscent of “ought to,” “count on,” “anticipate,” “estimate,” “goal,” “could,” “venture,” “steering,” “intend,” “plan,” “imagine” and different phrases and phrases of comparable which means and expression in reference to any dialogue of future working or monetary efficiency. Necessary elements that would trigger or contribute to such variations embody dangers regarding: our potential to efficiently develop duvakitug (Anti-TL1A) for the remedy of ulcerative colitis (UC) and Crohn’s illness (CD), together with to proceed to Section 3 research and procure required regulatory approvals; our potential to efficiently compete within the market, together with our potential to develop and commercialize extra pharmaceutical merchandise; our potential to efficiently execute our Pivot to Development technique, together with to broaden our progressive and biosimilar medicines pipeline and profitably commercialize the progressive medicines and biosimilar portfolio, whether or not organically or by means of enterprise improvement, and to maintain and focus our portfolio of generic medicines; the effectiveness of our patents and different measures to guard our mental property rights; and different elements mentioned in our Annual Report on Type 10-Okay for the yr ended December 31, 2024, together with within the sections captioned “Threat Components” and “Ahead-looking Statements.” Ahead-looking statements converse solely as of the date on which they’re made, and we assume no obligation to replace or revise any forward-looking statements or different data contained herein, whether or not on account of new data, future occasions or in any other case. You might be cautioned to not put undue reliance on these forward-looking statements.

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*P-values reported are one-sided at a significance degree of 0.10.
mMS = modified Mayo Rating; MES = Mayo Endoscopic Subscore; HEMI = Histological-Endoscopic Mucosal Enchancment; SES-CD = Easy Endoscopic Rating for Crohn’s Illness; CDAI = Crohn’s Illness Exercise Index; PRO2 = 2-item Affected person-Reported End result
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1. Reinisch, W., Stepek, D., Kempinski, R., Danese, S., Sands, B.E., Ratiu-Duma, B., Singh, R., Barkay, H., Raphael, G., Jairath, V. (2025, February 19-22). Duvakitug (TEV-48574), an anti-TL1A monoclonal antibody, demonstrates efficacy and beneficial security as an induction remedy in adults with reasonably to severely energetic ulcerative colitis: Outcomes from a section 2b, randomised, double-blind, placebo-controlled, dose-ranging, basket trial (RELIEVE UCCD) [Presentation OP40]. ECCO 2025, Berlin, Germany.
2. A Research to Consider the Lengthy-Time period Impact of TEV-48574 in Reasonable to Extreme Ulcerative Colitis or Crohn’s Illness. https://clinicaltrials.gov/research/NCT05668013?time period=TEV-48574&rank=1. Accessed February 2025.
3. A Research to Check the Impact of TEV-48574 in Reasonable to Extreme Ulcerative Colitis or Crohn’s Illness (RELIEVE UCCD) https://clinicaltrials.gov/research/NCT05499130?time period=TEV-48574&rank=2. Accessed February 2025.
4. Jairath, V., Kierkuś, J., Duvall, G.A., Danese, S. Sands, B.E., Ratiu-Duma, B., Singh, R., Barkay, H., Raphael, G., Reinisch, W. (2025, February 19-22). Duvakitug (TEV-48574), an anti-TL1a monoclonal antibody, demonstrates efficacy and beneficial security as an induction remedy in adults with reasonably to severely energetic Crohn’s illness: outcomes from a section 2b, randomised, double-blind, placebo-controlled dose-ranging, basket trial (RELIEVE UCCD) [Presentation OP41]. ECCO 2025, Berlin, Germany.
5. Inflammatory Bowel Illness (IBD) Fundamentals. Facilities for Illness Management and Prevention. 2022. Obtainable at: https://www.cdc.gov/inflammatory-bowel-disease/about/?CDC_AAref_Val=https://www.cdc.gov/ibd/what-is-IBD.html. Accessed February 2025.
6. Ulcerative Colitis Fundamentals. Facilities for Illness Management and Prevention. 2024. https://www.cdc.gov/inflammatory-bowel-disease/about/ulcerative-colitis-uc-basics.html. Accessed February 2025.
7. McDowell, C., Farooq, U., & Haseeb, M. (2020). Inflammatory Bowel Illness (IBD). PubMed; StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK470312/. Accessed February 2025.
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