Press Release: Late-breaking amlitelimab Phase 2b data presented at
EADV show potential best-in-class profile in atopic dermatitis
Late-breaking amlitelimab Phase 2b data
presented at EADV show potential best-in-class profile in atopic
dermatitis
- Patients treated
with amlitelimab experienced up to 61.5% improvement in average
Eczema Area and Severity Index (EASI) score from baseline at week
16, the primary endpoint, with continued improvement seen through
24 weeks
- Clinically
meaningful improvements were seen in all key secondary endpoints at
week 16 with continued improvements through week 24, including for
IGA 0/1 where patients on the highest dose experienced 22.1%
improvement at week 16 which increased to 45.5% by week 24
- Amlitelimab was
well-tolerated and no fever/chills, oral ulcers or imbalances with
conjunctivitis were observed across doses
- Amlitelimab has
a unique non-depleting mechanism of action targeting OX40-Ligand
with the potential to durably restore immune balance, sustained
effect and infrequent dosing
Paris, October 13, 2023.
Positive results from a Phase 2b study (STREAM-AD) showed that
amlitelimab significantly improved signs and symptoms of
moderate-to-severe atopic dermatitis in adults whose disease cannot
be adequately controlled with topical medications or for whom
topical medications are not a recommended treatment approach. These
detailed results were presented today as part of a late-breaking
session at the European Academy of Dermatology and Venereology
(EADV) 2023 Congress in Berlin. The Phase 3 program for
amlitelimab in atopic dermatitis is on track to start in the first
half of 2024. This program is part of Sanofi’s immunology strategy
built around exploring disruptive mechanisms of action designed to
deliver first and best-in-class treatments for people living with
chronic inflammatory diseases.
In this dose-ranging study, subcutaneous
treatment with amlitelimab resulted in statistically significant
improvements in the primary endpoint of percent change in Eczema
Area and Severity Index (EASI) score from baseline at 16 weeks
compared to placebo for all four doses that were studied. Among
these, patients treated with amlitelimab 250 mg Q4W with 500 mg
loading dose (LD) had the numerically highest response versus
placebo, showing a 61.5% reduction in EASI from baseline at week 16
(P<0.0001) and a 64.4% reduction at week 24 (P<0.0001) vs.
29.4% at week 16 and 27.6% at week 24 for placebo.
Professor Stephan Weidinger, M.D,
Ph.DDirector, Professor, Chair of Department of
Dermatology and Allergy, University Hospital Schleswig-Holstein
“These results are exciting news for patients with
moderate-to-severe atopic dermatitis who continue to suffer from
symptoms including persistent itch and skin lesions, despite
available treatment options. Across all four doses studied, we saw
consistent improvements in important signs and symptoms of the
disease with an unremarkable safety profile. These data also add to
the growing body of evidence that targeting OX40-Ligand potentially
stops the inflammatory cascade across multiple pathways resulting
in significant benefit for patients.”
Across amlitelimab doses, clinically meaningful
and nominally significant improvements were seen in all key
secondary endpoints at weeks 16 and 24, including Investigator
Global Assessment response of 0 (clear) or 1 (almost clear skin)
(IGA 0/1), 75% reduction from baseline in EASI (EASI-75) and weekly
average reduction of Peak Pruritus Numerical Rating Scale ≥4 points
from baseline (PP-NRS ≥4), with the exception of the 250 mg (no LD)
in IGA 0/1 at Week 16 (p=0.0562).
22.1% and 45.5% of patients treated with
amlitelimab 250 mg with LD achieved IGA 0/1 at weeks 16 and 24,
respectively, compared to 5.1% and 11.4% of placebo patients
(P=0.0022 and P<0.0001). Of patients treated with that same
dose, 40.3% and 54.5% achieved EASI-75 at weeks 16 and 24,
respectively, versus 11.4% and 17.7% on placebo (both
P<0.0001).
Across all doses at weeks 16 and 24, amlitelimab
treatment substantially reduced levels of biomarkers elevated in
atopic dermatitis, including Th2-related IL-13 and TARC,
Th17/Th22-related IL-17A and IL-22, and blood eosinophil counts,
with significant reduction observed as early as week 4 in the 250
mg with LD arm.
Houman Ashrafian, M.D.,
Ph.D.Global Head of Research & Development, Sanofi“The
data presented at EADV provide more detailed insight into
amlitelimab’s potential as a best-in-class therapy for people with
atopic dermatitis. In addition, our ability to pursue a
differentiated dosing regimen could be very meaningful to patients.
We look forward to initiating a larger Phase 3 development program
for amlitelimab in atopic dermatitis in the first half of 2024,
which further underscores our commitment to delivering a diverse
range of solutions for this chronic condition.”
Amlitelimab was well-tolerated in the study
across all dose arms and no new safety concerns were identified.
The overall rates of treatment-emergent adverse events (TEAEs) were
67.4% for amlitelimab and 60.3% for placebo. TEAEs more commonly
observed with amlitelimab compared to placebo included
nasopharyngitis (11.0% amlitelimab, 9.0% placebo), COVID-19 (7.7%
amlitelimab, 6.4% placebo) and headache (6.1% amlitelimab, 2.6%
placebo). Worsening of atopic dermatitis was more commonly observed
with placebo compared to amlitelimab (38.5% placebo, 17.1%
amlitelimab). No adverse events such as fever or chills, oral
ulcers or imbalances with conjunctivitis were observed across
doses.
Amlitelimab is a fully human non-depleting
monoclonal antibody that binds to OX40-Ligand, a key immune
regulator, and has the potential to be a first-in-class treatment
for a range of immune-mediated diseases and inflammatory disorders,
including moderate-to-severe atopic dermatitis and asthma. By
targeting OX40-Ligand, amlitelimab aims to restore balance between
pro-inflammatory and regulatory T cells.
Amlitelimab is currently under clinical
investigation, and its safety and efficacy have not been evaluated
by any regulatory authority.
About STREAM-ADSTREAM-AD, a Phase 2b study, is a
randomized double-blind, placebo-controlled study, evaluating
amlitelimab in adult patients with moderate-to-severe atopic
dermatitis whose disease was inadequately controlled with topical
therapies or where such therapies were not advisable. This study is
designed with two parts and is double-blind through both. The first
part is a 24-week treatment period and the second part, which is
still ongoing, is a 36-week maintenance/withdrawal period.
The primary endpoint is percentage change in
EASI from baseline at 16 weeks. Key secondary endpoints include
change in EASI from baseline at 24 weeks, percentage of patients
with a response of IGA 0 (clear) or 1 (almost clear skin) and a
reduction from baseline ≥ 2 points at 16 and 24 weeks, percentage
of patients with at least a 75% reduction from baseline in EASI at
16 and 24 weeks, and proportion of patients with improvement
(reduction) of weekly average of pruritus NRS ≥ 4 with a baseline
pruritus of ≥ 4 from baseline at 16 and 24 weeks.
In the first part, participants were randomized
1:1:1:1:1 to receive subcutaneous amlitelimab every four weeks or
placebo. The doses were: 250 mg with 500 mg loading dose [LD]
(n=77), 250 mg without LD (n=78), 125 mg without LD (n=77), 62.5 mg
without LD, (n=79) or placebo (n=79).
The study enrolled 390 people in Australia,
Bulgaria, Canada, Czechia, Germany, Hungary, Japan, Poland, Spain,
Taiwan, the United Kingdom and the United States.
About Sanofi’s Immunology
PipelineThrough world-class R&D and a laser focus on
patients, Sanofi discovers, develops and delivers first and
best-in-class treatments that improve the lives of people living
with chronic inflammatory diseases. Our scientific strategy for the
future of immunology is built around the intentional choice of
exploring disruptive mechanisms of action beyond Type 2
inflammation through using a variety of approaches including
NANOBODY® molecules, synthetic cytokines and degraders. The
immunology pipeline consists of 6 investigational agents in Phase 1
clinical development, 5 in Phase 2 clinical development, and 1 in
Phase 3 clinical development. These programs include
investigational agents across a wide range of inflammatory
conditions.
About SanofiWe are an innovative global
healthcare company, driven by one purpose: we chase the miracles of
science to improve people’s lives. Our team, across some 100
countries, 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
Guendoul | + 33 6 25 09 14 25
| sandrine.guendoul@sanofi.comSally
Bain | + 1 617 834 6026
| sally.bain@sanofi.comVictor
Rouault | + 33 6 70 93 71 40
| victor.rouault@sanofi.com
Investor RelationsEva
Schaefer-Jansen | + 33 7 86 80 56 39
| eva.schaefer-jansen@sanofi.comArnaud
Delépine | + 33 6 73 69 36 93 |
arnaud.delepine@sanofi.comCorentine
Driancourt | + 33 6 40 56 92 21 |
corentine.driancourt@sanofi.comFelix
Lauscher | + 1 908 612 7239 |
felix.lauscher@sanofi.comTarik Elgoutni| + 1 617
710 3587 | tarik.elqoutni@sanofi.comNathalie
Pham | + 33 7 85 93 30 17 |
natalie.pham@sanofi.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,
2022. Other than as required by applicable law, Sanofi does not
undertake any obligation to update or revise any forward-looking
information or statements.
Grafico Azioni Sanofi (BIT:1SAN)
Storico
Da Apr 2024 a Mag 2024
Grafico Azioni Sanofi (BIT:1SAN)
Storico
Da Mag 2023 a Mag 2024