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
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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
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*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.
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