Press Release: New Phase 2b results for amlitelimab support
potential for best-in-class maintenance of response in atopic
dermatitis
New Phase 2b results for amlitelimab support
potential for best-in-class maintenance of response in atopic
dermatitis
- Late-breaking
data at AAD show sustained off-drug improvements of AD signs and
symptoms with amlitelimab for 28 weeks
- The safety
profile for patients dosed to 52 weeks was consistent with
amlitelimab 24 weeks data showing it to be well-tolerated with no
new safety concerns identified
- Durability of
response supports quarterly dosing currently being investigated in
Phase 3 pivotal program
- Sustained
biomarker reduction suggests the modulation of immune response and
durable disease control via the blockade of OX40L, a non-T cell
depleting mechanism
- Amlitelimab is
one of 12 potential blockbusters in Sanofi’s leading immunology
pipeline, results for a Phase 2 asthma study expected in H2 2024
and three additional Phase 2 study starts expected by year-end
Paris, March 11, 2024. Positive
results from Part 2 of the investigational amlitelimab Phase 2b
study STREAM-AD showed sustained improvement of signs and symptoms
for 28 weeks in adults with moderate to severe AD who previously
responded to amlitelimab and continued treatment. High responder
rates were also observed in participants who were taken off
amlitelimab. The safety profile was consistent with Part 1 of the
study with amlitelimab being well-tolerated and no new safety
concerns identified. These results were presented as part of a
late-breaking session at the American Academy of Dermatology (AAD)
2024 Conference in San Diego and support the quarterly (every
12-week) dosing of amlitelimab 250 mg with 500 mg loading dose (LD)
now being investigated in a larger Phase 3 clinical program
(OCEANA).
Professor Stephan Weidinger, M.D,
Ph.D Director, Professor, Chair of Department of
Dermatology and Allergy, University Hospital
Schleswig-Holstein
“Despite available treatment options, not all
patients with moderate-to-severe atopic dermatitis respond
sufficiently to these treatments, and many continue to suffer from
skin lesions and symptoms such as persistent itch, which can have a
high impact on their day-to-day lives. Results from this part of
the study indicate amlitelimab’s potential for durable off-drug
efficacy which supports the evaluation of a less frequent every
12-week dosing. This could offer an important benefit in the
treatment of AD patients.”
In the second part of the dose-ranging STREAM-AD
study, responders to amlitelimab who achieved a 75% improvement in
Eczema Area and Severity Index (EASI-75) score and/or Investigator
Global Assessment (IGA) score of 0 or 1 during the 24-week
treatment period (Part 1) were re-randomized to explore the
maintenance of clinical response over an additional 28-week period
with continued amlitelimab treatment or amlitelimab withdrawal.
Across all dose arms, patients who continued amlitelimab treatment
maintained high EASI-75 and/or IGA 0/1, IGA 0/1, and EASI-75
responder rates through 28 weeks. High responder rates were also
demonstrated among patients who were taken off treatment.
In 69.2% of patients with continued treatment
with amlitelimab 250 mg Q4W with 500 mg loading dose (LD) vs 58.8%
of patients withdrawn from treatment IGA 0/1 and/or EASI-75
response was maintained.
An analysis including pooled dose-arms showed
that IGA 0/1 response was maintained in 71.9% of patients with
continued treatment vs 57% of patients withdrawn from treatment. In
this analysis, EASI-75 response was maintained in 69% of patients
with continued treatment vs. 61.6% of patients withdrawn from
treatment.
AD-related biomarkers remained reduced at Week
52 in both amlitelimab withdrawn and continuing groups, despite
amlitelimab reaching negligible levels in serum. Reduction of TARC,
eosinophils, and IL-22 observed at Week 24 was maintained during
withdrawal as well as in patients continuing treatment to Week 52.
These biomarker data suggest the modulation of inflammatory T cells
via the blockade of OX40L and durable control of AD after
amlitelimab withdrawal.
Naimish Patel, M.D.Head of
Global Development, Immunology and Inflammation, Sanofi
“It’s unprecedented to see this type of
durability of clinical response, which we believe could be very
meaningful to patients and is the reason why we selected an every
12-week dosing regimen in the AD pivotal program. AD is a chronic,
lifelong disease, which means we must strive to provide a portfolio
of solutions to patients that matches their individual needs and
puts as little burden on them as possible. We are also moving with
speed in our exploration of amlitelimab's potential in 5 other
chronic inflammatory diseases, including asthma, hidradenitis
suppurativa, scleroderma, celiac disease, and alopecia. In
addition, we are exploring 6 other innovative MOAs in 8
dermatologic indications underscoring our commitment to patients
with high unmet medical needs.”
The aggregated safety profile of amlitelimab in
Part 2 of this study was consistent with that of Part 1, with
amlitelimab being well-tolerated, and no new safety concerns were
identified during the 28-week maintenance/withdrawal period.
Overall rates of treatment-emergent adverse events (TEAEs) were
69.8% for continued amlitelimab treatment, 71.9% for the
amlitelimab withdrawal-arm and 66.7% for placebo. TEAEs more
commonly observed included headache (11.6% amlitelimab
continuation, 3.9% amlitelimab withdrawal, 6.7% placebo), upper
respiratory tract infection (9.3% amlitelimab continuation, 5.5%
amlitelimab withdrawal, 20% placebo). No adverse events such as
fever or chills, oral ulcers or conjunctivitis were observed across
doses.
Amlitelimab is a fully human non-T cell
depleting monoclonal antibody that blocks OX40-Ligand, a key immune
regulator, and has the potential to be a first- or best-in-class
treatment for a range of immune-mediated diseases and inflammatory
disorders, including moderate-to-severe atopic dermatitis (Phase
3), asthma (Phase 2), hidradenitis suppurativa (Phase 2),
scleroderma, celiac disease, and alopecia (Phase 2 studies to be
initiated in 2024). 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. Part 1
was a 24-week treatment period, and Part 2 was a 28-week
maintenance/withdrawal period, which included clinical responders
from Part 1, defined as participants achieving EASI-75 and/or IGA
0/1 at Week 24. Of 390 participants enrolled in Part 1, 190 entered
Part 2. Participants were re-randomized 3:1 to withdraw treatment
or continue pre-Week 24 subcutaneous Q4W dose (250mg with 500mg
loading dose (LD), 250mg, 125mg, 62.5mg, placebo responders
continuing placebo), and were followed to Week 52 for efficacy.
The study enrolled 390 people in Australia,
Bulgaria, Canada, Czechia, Germany, Hungary, Japan, Poland, Spain,
Taiwan, the United Kingdom and the United States.
About SanofiWe are an innovative global
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