ECCO 2025: new duvakitug data reinforce
best-in-class potential in ulcerative colitis and Crohn’s
disease
- New detailed data from the RELIEVE
UCCD study support overall efficacy and safety of duvakitug in all
pre-specified subgroups across the different doses
- New endpoints presented include
findings on clinical and endoscopic outcomes and
histological-endoscopic mucosal improvement
- Findings to form the basis for a
phase 3 program, anticipated to start in H2 2025
Paris and Parsippany, NJ, February 22,
2025. Sanofi and Teva Pharmaceuticals, a US affiliate of
Teva Pharmaceutical Industries Ltd., today presented new, detailed
results from the RELIEVE UCCD phase 2b study of duvakitug, a human
IgG1-λ2 monoclonal antibody targeting TL1A, in patients with
moderate-to-severe ulcerative colitis (UC) and Crohn’s disease
(CD), the two most common forms of inflammatory bowel disease
(IBD). These results were shared in two oral presentations at the
20th Congress of the European Crohn’s and Colitis Organisation
(ECCO) in Berlin, Germany.
Ulcerative colitis In the UC cohort of the
RELIEVE UCCD study, 36% (450 mg dose) and 48% (900 mg dose) of
patients treated with duvakitug achieved the primary endpoint of
clinical remission (mMS)* at week 14 compared to 20% treated with
placebo; placebo-adjusted rates were 16% (450 mg dose) and 27% (900
mg dose) (p=0.050 and 0.003, respectively).
In addition, higher clinical remission rates
were observed for both doses of duvakitug versus placebo in both
advanced therapy (AT) -experienced and AT-naïve subgroups of
patients.
- AT-experienced:
29% (450 mg) and 36% (900 mg), with placebo-adjusted rates of 22%
(450 mg) and 29% (900 mg).
- AT-naïve: 39%
(450 mg) and 53% (900 mg), with placebo-adjusted rates of 12% (450
mg) and 26% (900 mg).
Additional endpoints observed*:
- Clinical
response (mMS): 81% (450 mg) and 70% (900 mg) compared to 52%
treated with placebo.
- Endoscopic
improvement (MES): 45% (450 mg) and 50% (900 mg) compared to 23%
treated with placebo.
- Histological-endoscopic mucosal
improvement (HEMI): 30% (450 mg) and 33% (900 mg) compared to 16%
treated with placebo.
Walter Reinisch, MD, PhD,
Medical University of Vienna, and lead investigator of the RELIEVE
UCCD study “Patients, many of whom have spent years in a recurring
cycle of remission and relapse, have been waiting a long time for
better options in treating ulcerative colitis. We’re highly
encouraged by the significant treatment response, compared to
placebo, seen in the study, both in advanced therapy naïve-and
experienced patients,” said Walter Reinisch, MD, PhD, Medical
University of Vienna, and lead investigator of the RELIEVE UCCD
study. “With this potential of duvakitug to reduce inflammation, we
could truly transform treatment for patients with IBD in a safe
manner.”
Crohn’s diseaseIn the CD cohort of the RELIEVE
UCCD study, 26% (450 mg dose) and 48% (900 mg dose) of patients
treated with duvakitug achieved the primary endpoint of endoscopic
response (SES-CD)* compared to 13% on placebo; placebo-adjusted
rates were 13% (450 mg dose) and 35% (900 mg dose) at week 14 (p=
0.058 and <0.001, respectively).
In addition, higher endoscopic response rates
were observed for both doses of duvakitug versus placebo in both
AT-experienced and AT-naïve subgroups of patients.
- AT-experienced:
11% (450 mg) and 48% (900 mg), with placebo-adjusted rates of 7%
(450 mg) and 44% (900 mg).
- AT-naïve: 47%
(450 mg) and 47% (900 mg), with placebo-adjusted rates of 25% (450
mg) and 25% (900 mg).
Additional endpoints observed*:
- Endoscopic
remission (SES-CD): 17% (450 mg) and 26% (900 mg) compared to 9%
treated with placebo.
- Clinical
remission (CDAI): 50% (450 mg) and 54% (900 mg) compared to 41%
treated with placebo.
- Clinical
response (CDAI): 61% (450 mg) and 62% (900 mg) compared to 41%
treated with placebo.
- Clinical response (PRO2): 50% (450
mg) and 53% (900 mg) compared to 29% treated with placebo.
Vipul Jairath, MBChB, DPhil, FRCP,
FRCPCProfessor of Medicine in the Departments of Medicine,
Epidemiology and Biostatistics at Western University, and lead
investigator of the RELIEVE UCCD study “Every day, I see patients
with Crohn’s disease who continue to suffer from the often-severe
symptoms of the disease despite available treatments,” said Vipul
Jairath, MBChB, DPhil, FRCP, FRCPC, Professor of Medicine in the
Departments of Medicine, Epidemiology and Biostatistics at Western
University, and lead investigator of the RELIEVE UCCD study. “The
endoscopic response rates seen in this study support the potential
of duvakitug as an effective new option for those who are in
desperate need of relief.”
RELIEVE UCCD safety data summaryIn both the UC
and CD cohorts, duvakitug was generally well tolerated with no
emergent safety signals observed. No dose-dependent or adverse
event (AE) pattern was observed for treatment-related AEs, serious
adverse events (SAEs), AEs leading to discontinuation or adverse
events of special interest (AESIs).
Duvakitug is currently under clinical
investigation, and its efficacy and safety have not been evaluated
by any regulatory authority.
About inflammatory bowel disease UC 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 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 was 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. The study was an innovative and
efficient basket study design allowing the inclusion of patients
with either type UC and CD. It is also the first and only
randomized, blinded and placebo-controlled phase 2 study to
investigate the impact of TL1A in 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. The UC cohort
comprised adults with moderately to severely active disease with
inadequate response, loss of response or intolerance to previous
conventional and/or advanced therapies (AT). The CD cohort
comprised adults with moderately to severely active disease with
documented inadequate response, loss of response or intolerance to
conventional and/or ATs.
Primary efficacy endpoints are the number of
participants who showed clinical remission (as defined by the
modified Mayo score) in the UC cohort or the number of participants
who showed endoscopic response (as defined by the SES-CD endoscopic
score for CD) in the CD cohort. The study included sites in the US,
Europe, Israel, and Asia.
About duvakitugDuvakitug 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 drive fibrosis associated with IBD through
binding its receptor, death receptor 3 (DR3).
Duvakitug is uniquely designed to inhibit
preferentially TL1A signaling via DR3, with the potential advantage
of reduced TL1A-DcR3 inhibition.
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 Teva and Sanofi collaborationTeva and
Sanofi are collaborating to co-develop and co-commercialize Teva’s
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 Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE:
TEVA) is a different kind of global pharmaceutical leader, one that
operates across the full spectrum of innovation to reliably deliver
medicines to patients worldwide. 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 57 markets to advance health by developing
medicines for the future while championing the production of
generics and biologics. If patients have a need, we’re already
working to address it. 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
Media RelationsSandrine
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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
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*P-values reported are one-sided at a
significance level of 0.10.
mMS = modified Mayo Score; MES = Mayo Endoscopic
Subscore; HEMI = Histological-Endoscopic Mucosal Improvement;
SES-CD = Simple Endoscopic Score for Crohn’s Disease; CDAI =
Crohn’s Disease Activity Index; PRO2 = 2-item Patient-Reported
Outcome
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