- Results demonstrate rapid and sustained suppression of free
TL1A, confirming target engagement of anti-TL1A
(TEV-’574)1
- Anti-TL1A (TEV-’574) was shown to be safe and
well-tolerated, with a low incidence of antidrug
antibodies2
- Data support the ongoing Phase 2b clinical investigation of
anti-TL1A (TEV-’574) in inflammatory bowel disease3
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical
Industries Ltd. (NYSE and TASE: TEVA), today announced positive
safety, tolerability, and pharmacokinetic data for its anti-TL1A
(TEV-’574) asset, a potentially best-in-class human IgG1 monoclonal
antibody that targets the tumor necrosis factor (TNF)-like ligand
1A (TL1A) and is designed to offer both anti-inflammatory and
anti-fibrotic effects.1-3
The data show the rapid and sustained suppression of free TL1A,
confirming the target engagement of anti-TL1A (TEV-’574), and show
a well-tolerated safety profile in patients with asthma, which
support continued clinical investigation for moderate-to-severe
inflammatory bowel disease (IBD); this includes ulcerative colitis
(UC) and Crohn's disease (CD).1-3 These findings will be presented
at the 19th Annual Congress of the European Crohn’s and Colitis
Organisation (ECCO), which takes place February 21-24, 2024, in
Stockholm, Sweden.
“These results from the first-in-human trials of anti-TL1A
(TEV-’574) are exciting because they show that it effectively
engages with the TL1A target, supports its safety profile and is
well-tolerated. This aligns with our extensive pre-clinical
evidence and further supports ongoing clinical investigations of
anti-TL1A (TEV-’574) in IBD, where TL1A plays a prominent role in
amplification of immune response leading to burdensome inflammation
and fibrosis in the gastrointestinal tract,” said Dr. Eric Hughes,
Executive Vice President of Global R&D and Chief Medical
Officer at Teva. “We are currently investigating the efficacy and
safety of anti-TL1A (TEV-’574) in IBD through the RELIEVE UCCD
Phase 2 trial, which features an innovative and efficient basket
study design allowing the inclusion of patients with either type of
IBD (ulcerative colitis and Crohn’s disease). These data reinforce
the potential for anti-TL1A (TEV-’574) to become a novel treatment
option for IBD and solidifies our ongoing commitment to provide
innovative medicines to improve the lives of people living with
IBD, as quickly as possible.”
First-in-human pharmacokinetic and safety data for anti-TL1A
(TEV-'574) from a Phase 1 study in healthy volunteers and patients
with mild asthma and a Phase 2 study in patients with severe asthma
show:
- Dose-proportional increases in anti-TL1A (TEV-’574) exposure
and minimal accumulation after multiple dosing every two
weeks.1
- A rapid and prolonged decrease in free TL1A levels indicating
successful target engagement. This decrease was sustained up to two
months after the last dose despite low or undetectable anti-TL1A
(TEV-'574) levels.1
- A favorable safety profile and well tolerated up to doses of
2300mg.1,2
Also to be presented at ECCO 2024 is the study design of the
RELIEVE UCCD Phase 2 trial investigating the efficacy and safety of
anti-TL1A (TEV-’574) in patients with moderate-to-severe UC or CD.3
This first-ever basket study design for an IBD trial offers an
efficient approach to help advance anti-TL1A (TEV-’574) to Phase 3
studies.
On November 30, 2023, Teva and Sanofi (EURONEXT: SAN and NASDAQ:
SNY) announced the closing of their collaboration deal to
co-develop and co-commercialize anti-TL1A (TEV-‘574) for the
treatment of UC and CD, two types of inflammatory bowel disease.4
Under the terms of the agreement, Teva received an upfront payment
of $500 million shortly after closing and will receive up to $1
billion in development and launch milestones. Each company will
equally share the development costs globally and net profits and
losses in major markets, with other markets subject to a royalty
arrangement, and 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 the term for two conditions
― Crohn’s disease (CD) and ulcerative colitis (UC) ― characterized
by chronic inflammation of the gastrointestinal (GI) tract.5 CD and
UC are chronic inflammatory conditions in 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. No cure exists for IBD –
the goal of treatment is to induce and maintain remission and
prevent flares.6 Globally, ~4.9 million cases of IBD have been
identified, with incidence rising in several regions.7
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 anti-TL1A (TEV-’574) 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 anti-TL1A (TEV-’574)
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.8,9
About Anti-TL1A (TEV-’574)
Anti-TL1A (TEV-’574) is a potentially best-in-class human IgG1
monoclonal antibody that targets tumor necrosis factor (TNF)-like
ligand 1A (TL1A), also known as TNF superfamily member 15. TL1A
signaling is believed to amplify inflammation and drives fibrosis
associated with asthma and inflammatory bowel disease (IBD); thus,
targeting TL1A with TEV-’574 may mitigate the over-active immune
response in these conditions. Anti-TL1A (TEV-’574) is currently in
Phase 2b clinical trials for the treatment of ulcerative colitis
(UD) and Crohn's disease (CD), two types of inflammatory bowel
disease. The safety and efficacy of anti-TL1A (TEV-’574) 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 anti-TL1A (TEV-’574)
asset for the treatment of ulcerative colitis and Crohn’s disease,
two types of inflammatory bowel disease; our exclusive
collaboration with Sanofi; the risk that we will incur significant
costs in connection with the development of anti-TL1A (TEV-’574),
which may exceed any revenue generated by anti-TL1A (TEV-’574);
risks that regulatory approvals and other requirements may delay
the development and commercialization of our anti-TL1A (TEV-’574);
our ability to successfully launch and 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; our business and operations in general,
including the impact of global economic conditions and other
macroeconomic developments and the governmental and societal
responses thereto; the impact of the state of war declared in
Israel and the military activity in the region, including the risk
of disruptions to our operations and facilities, such as our
manufacturing and R&D facilities, located in Israel; and other
factors discussed in this press release 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.
______________________
- Balyan, R., Ghibellini, G., Sunzel, E. M. et al. (2024). P633
First-in-Human Pharmacokinetic and Safety Study of an Anti-TL1A
Antibody, TEV-48574, in Healthy Volunteers and Asthma Patients.
Journal of Crohn’s and Colitis, 18(Supplement_1), i1215–i1216.
https://doi.org/10.1093/ecco-jcc/jjad212.0763.
- Raphael, G., Damera. G., Angeles, T. et al. (2024). P1061
TEV-48574, an anti-TL1A antibody in development for use in IBD, is
safe and well tolerated following 16 weeks of subcutaneous
treatment in adults with severe uncontrolled T2-low/non T2 asthma.
Journal of Crohn’s and Colitis, 18(Supplement_1), i1908–i1908.
https://doi.org/10.1093/ecco-jcc/jjad212.1191.
- Reinisch, W., Stoyanov, S., Raphael, G. et al. (2024). P998
Phase 2 basket design study evaluating the efficacy and safety of
an anti-TL1A antibody (TEV-48574) in moderate to severe ulcerative
colitis or Crohn’s Disease (RELIEVE UCCD). Journal of Crohn’s and
Colitis, 18(Supplement_1), i1811–i1811.
https://doi.org/10.1093/ecco-jcc/jjad212.1128.
- Teva Completes Closing of Exclusive Collaboration Deal to
Deliver Inflammatory Bowel Disease Treatment.
https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2023/Teva-Completes-Closing-of-Exclusive-Collaboration-Deal-to-Deliver-Inflammatory-Bowel-Disease-Treatment/default.aspx.
Accessed Feb 2024.
- 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 Feb 2024.
- McDowell, C., Farooq, U., & Haseeb, M. (2020). Inflammatory
Bowel Disease (IBD). PubMed; StatPearls Publishing.
https://www.ncbi.nlm.nih.gov/books/NBK470312/.
- 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 Feb 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 Feb 2024.
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