Duvakitug positive phase 2b results demonstrate
best-in-class potential in ulcerative colitis and Crohn’s
disease
- Primary
endpoints met in ulcerative colitis (UC) and Crohn’s disease (CD),
the most common forms of inflammatory bowel disease (IBD)
- Primary endpoint results in UC and
CD for high dose represent the highest achieved with any TL1A
monoclonal antibody
- Sanofi and Teva plan to initiate
phase 3 development in IBD, pending regulatory discussions
- Program underscores Sanofi's
Immunology leadership ambition
Paris and Parsippany, NJ, December 17,
2024. Sanofi and Teva Pharmaceuticals, a US affiliate of
Teva Pharmaceutical Industries Ltd., today announced that the
RELIEVE UCCD phase 2b study met its primary endpoints in patients
with ulcerative colitis (UC) and Crohn’s disease (CD). RELIEVE UCCD
assessed duvakitug, a human IgG1-λ2 monoclonal antibody targeting
TL1A, for the treatment of moderate-to-severe inflammatory bowel
disease (IBD).
In the RELIEVE UCCD study, 36.2% (low dose) and
47.8% (high dose) of patients with UC treated with duvakitug
achieved clinical remission* compared to 20.45% on placebo,
placebo-adjusted rates were 15.7% (low dose) and 27.4% (high dose),
at week 14 (p=0.050 and 0.003, respectively).* In patients with CD,
26.1% (low dose) and 47.8% (high dose) treated with duvakitug
achieved endoscopic response* compared to 13.0% on placebo,
placebo-adjusted rates were 13.0% (low dose) and 34.8% (high dose),
at week 14 (p= 0.058 and <0.001, respectively).* Overall, the
treatment effect was consistent across subgroups. This is the first
and only randomized, placebo-controlled study to evaluate the
impact of an anti-TL1A monoclonal antibody in CD. Detailed results
are expected to be presented at a scientific forum in 2025.
Duvakitug was generally well tolerated in both
UC and CD with no safety signal identified. Overall rates of
treatment emergent adverse events (AE) were similar between
duvakitug and placebo across both UC and CD (50% vs 50%). All AEs
reported across both UC and CD were less than 5%.
Houman Ashrafian, MD, PhD
Executive Vice President, Head of Research & Development at
Sanofi “These unprecedented results show that duvakitug could
represent the next frontier in treating ulcerative colitis and
Crohn’s disease. If the magnitude of effect persists in the phase 3
program, we believe we will have a differentiated medicine for IBD
patients who are in urgent need of new options,” said Houman
Ashrafian, MD, PhD, Head of R&D at Sanofi. “The duvakitug
program and this partnership underscore Sanofi’s strategy of
following the science to identify and rapidly advance breakthrough
medicines for patients.”
Eric Hughes, MD, PhDHead of
Global Research & Development and Chief Medical Officer at
Teva“The results from the RELIEVE UCCD study have exceeded our
expectations, and I am deeply moved by the potential of duvakitug
to help treat and meaningfully improve the quality of life of
people living with IBD,” said Eric Hughes, MD, PhD, Head of Global
R&D and Chief Medical Officer at Teva. “These positive results
reinforce Teva's ability to develop and accelerate access to
innovative medicines. We are excited to collaborate on the next
phase of development with our partner, Sanofi, and we would like to
thank the investigators and patients who participated in this
study.”
Duvakitug is currently under clinical
investigation, and its efficacy and safety have not been evaluated
by any regulatory authority.
About IBDUC and CD, the two main types of IBD,
are chronic inflammatory conditions of the gastrointestinal (GI)
tract resulting in debilitating and persistent symptoms such as
abdominal pain, diarrhea, rectal bleeding, fatigue, and weight
loss. 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 often
requiring hospitalization and surgery. There is currently no cure
for IBD – the goal of treatment is to induce and maintain remission
and prevent flares.
About the RELIEVE UCCD phase 2b studyRELIEVE
UCCD is a 14-week phase 2b, randomized, double-blinded,
dose-ranging study to determine the efficacy, safety,
pharmacokinetics, and tolerability of duvakitug in adults with
moderate to severe UC or CD. In the study, patients who met
pre-specified inclusion criteria were randomized to receive one of
two duvakitug doses or placebo, administered every two weeks
subcutaneously, in a 1:1:1 ratio for each indication (UC or CD)
stratified by previous exposure to advanced IBD therapies for 14
weeks.
Participants who completed the 14-week induction
study were eligible to participate in a long-term extension (LTE)
study, currently ongoing. Responders from the induction study could
enter the LTE directly into a 44-week maintenance period to receive
a low or high dose every four weeks. Non-responders could enter a
14-week re-induction period. Responders to re-induction entered the
44-week maintenance period. Participants who responded during the
maintenance period are eligible for an open-label period within the
LTE. Primary efficacy endpoints for both the 14-week induction
study and the 44-week maintenance study are the number of
participants who show clinical remission (as defined by the
modified Mayo score) in the UC cohort or the number of participants
who show endoscopic response (as defined by the SES-CD endoscopic
score for CD) in the CD cohort. The study includes sites in the US,
Europe, Israel, and Asia.
About duvakitug Duvakitug is a potential
best-in-class human IgG1-λ2 monoclonal antibody that targets tumor
necrosis factor (TNF)-like ligand 1A, also known as TNF superfamily
member 15. TL1A signaling is believed to amplify inflammation and
drive fibrosis associated with IBD through binding its receptor,
DR3; thus, targeting TL1A with duvakitug may mitigate the
over-active immune response in these conditions. Duvakitug is
currently in a phase 2b clinical study for the treatment of UC and
CD, the two most common types of IBD. The safety and efficacy of
duvakitug have not been reviewed by any regulatory authority.
About the Sanofi and Teva collaborationSanofi
and Teva are collaborating to co-develop and co-commercialize
duvakitug for the treatment of UC and CD. Each company will equally
share the development costs globally, and the net profits and
losses in major markets, with other markets subject to a royalty
arrangement. Sanofi will lead the phase 3 clinical development
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 TevaTeva 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.
About Sanofi We are an innovative global
healthcare company, driven by one purpose: we chase the miracles of
science to improve people’s lives. Our team, across the world, is
dedicated to transforming the practice of medicine by working to
turn the impossible into the possible. We provide potentially
life-changing treatment options and life-saving vaccine protection
to millions of people globally, while putting sustainability and
social responsibility at the center of our ambitions.Sanofi is
listed on EURONEXT: SAN and NASDAQ: SNY
Sanofi Media RelationsSandrine
Guendoul | + 33 6 25 09 14 25 |
sandrine.guendoul@sanofi.com Evan Berland | +1 215
432 0234 | evan.berland@sanofi.comNicolas Obrist |
+ 33 6 77 21 27 55 | nicolas.obrist@sanofi.com Léo Le
Bourhis | + 33 6 75 06 43 81 |
leo.lebourhis@sanofi.comVictor Rouault | + 33 6 70
93 71 40 | victor.rouault@sanofi.comTimothy
Gilbert | + 1 516 521 2929 |
timothy.gilbert@sanofi.com
Sanofi Investor RelationsThomas Kudsk
Larsen |+ 44 7545 513 693 |
thomas.larsen@sanofi.comAlizé Kaisserian | + 33 6
47 04 12 11 | alize.kaisserian@sanofi.com Felix
Lauscher | + 1 908 612 7239 |
felix.lauscher@sanofi.comKeita Browne | + 1 781
249 1766 | keita.browne@sanofi.comNathalie Pham |
+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Tarik
Elgoutni | + 1 617 710 3587 |
tarik.elgoutni@sanofi.comThibaud Châtelet | + 33 6
80 80 89 90 | thibaud.chatelet@sanofi.com
Teva Media
RelationsTevaCommunicationsNorthAmerica@tevapharm.com
Teva Investor Relations TevaIR@tevapharm.com
Sanofi forward-looking
statementsThis press release contains forward-looking
statements as defined in the Private Securities Litigation Reform
Act of 1995, as amended. Forward-looking statements are statements
that are not historical facts. These statements include projections
and estimates and their underlying assumptions, statements
regarding plans, objectives, intentions, and expectations with
respect to future financial results, events, operations, services,
product development and potential, and statements regarding future
performance. Forward-looking statements are generally identified by
the words “expects”, “anticipates”, “believes”, “intends”,
“estimates”, “plans” and similar expressions. Although Sanofi’s
management believes that the expectations reflected in such
forward-looking statements are reasonable, investors are cautioned
that forward-looking information and statements are subject to
various risks and uncertainties, many of which are difficult to
predict and generally beyond the control of Sanofi, that could
cause actual results and developments to differ materially from
those expressed in, or implied or projected by, the forward-looking
information and statements. These risks and uncertainties include
among other things, the uncertainties inherent in research and
development, future clinical data and analysis, including post
marketing, decisions by regulatory authorities, such as the FDA or
the EMA, regarding whether and when to approve any drug, device or
biological application that may be filed for any such product
candidates as well as their decisions regarding labelling and other
matters that could affect the availability or commercial potential
of such product candidates, the fact that product candidates if
approved may not be commercially successful, the future approval
and commercial success of therapeutic alternatives, Sanofi’s
ability to benefit from external growth opportunities, to complete
related transactions and/or obtain regulatory clearances, risks
associated with intellectual property and any related pending or
future litigation and the ultimate outcome of such
litigation, trends in exchange rates and prevailing interest
rates, volatile economic and market conditions, cost containment
initiatives and subsequent changes thereto, and the impact that
pandemics or other global crises may have on us, our customers,
suppliers, vendors, and other business partners, and the financial
condition of any one of them, as well as on our employees and on
the global economy as a whole. The risks and uncertainties
also include the uncertainties discussed or identified in the
public filings with the SEC and the AMF made by Sanofi, including
those listed under “Risk Factors” and “Cautionary Statement
Regarding Forward-Looking Statements” in Sanofi’s annual report on
Form 20-F for the year ended December 31, 2023. Other than as
required by applicable law, Sanofi does not undertake any
obligation to update or revise any forward-looking information or
statements.
All trademarks mentioned in this press release
are the property of the Sanofi group.
Teva Cautionary note regarding
forward-looking statementsThis 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 develop duvakitug for the treatment of
ulcerative colitis (UC) and Crohn’s disease (CD); our ability to
successfully compete in the marketplace, including our ability to
develop and commercialize additional pharmaceutical products; 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 generic
medicines; the effectiveness of our patents and other measures to
protect our intellectual property rights; and other factors
discussed in our Quarterly Report on Form 10-Q for the third
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.
*As measured by the Modified Mayo Score (MMS)
and as measured by the Simple Endoscopic Score for Crohn’s Disease
(SES-CD), respectively. P-values reported are one-sided at a
significance level of 0.10.
Grafico Azioni Sanofi (EU:SAN)
Storico
Da Nov 2024 a Dic 2024
Grafico Azioni Sanofi (EU:SAN)
Storico
Da Dic 2023 a Dic 2024
