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
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