New, late-breaking data at EADV highlights emerging clinical
profile of amlitelimab (formerly KY1005) in adults with
inadequately controlled moderate-to-severe atopic dermatitis
New, late-breaking data at
EADV highlights emerging
clinical profile of
amlitelimab (formerly KY1005)
in adults with
inadequately controlled
moderate-to-severe
atopic dermatitis
- Low dose arm of the study met the co-primary endpoints of
percent change in Eczema Area and Severity Index (EASI) score from
baseline, and incidence of treatment-emergent adverse events,
through week 16
- First trial to assess the effects of blocking OX40-Ligand, a
key immune system regulator, in patients with moderate-to-severe
atopic dermatitis
- Data support amlitelimab as a potential first-in-class
anti-OX40-Ligand monoclonal antibody for adults with
moderate-to-severe atopic dermatitis
PARIS
– September 30, 2021 – Positive
results from a Phase 2a study evaluating the safety and efficacy of
amlitelimab, a human monoclonal antibody targeting key immune
system regulator OX40-Ligand, were presented as a late-breaker
today at the European Academy of Dermatology and Venerology (EADV)
2021 Virtual Congress. In the study, amlitelimab showed significant
improvements in signs and symptoms of moderate-to-severe atopic
dermatitis with a well-tolerated safety profile in adults whose
disease cannot be adequately controlled with topical medications or
for whom topical medications are not a recommended treatment
approach. "While new
options are increasingly available for the treatment of atopic
dermatitis, individual patients have different responses to
therapies and therefore require different solutions," said
Professor Stephan Weidinger, M.D., Ph.D., Vice Director, Professor,
Department of Dermatology and Allergy, University Hospital
Schleswig-Holstein. “In the Phase 2a study presented at EADV,
amlitelimab was shown to meaningfully improve the signs and
symptoms of atopic dermatitis patients with moderate to severe
disease with an unremarkable safety profile. These early results
are exciting, and we look forward to seeking confirmatory data in
future amlitelimab clinical trials.”
In this Phase 2a double-blind,
placebo-controlled study, participants were randomized to either
intravenous amlitelimab-low dose (LD) (n=29), intravenous
amlitelimab-high dose (HD) (n=30) or placebo (n=29) and were
treated every four weeks over a 12-week period. Eligible patients
included adults with moderate-to-severe atopic dermatitis whose
disease is inadequately controlled with topical therapies such as
corticosteroids, or where such therapies were not advisable.
Co-primary endpoints included percent change in EASI from
baseline, and incidence of treatment-emergent adverse events
(TEAEs), at week 16.
At week 16, the data demonstrated that when dosed every four
weeks:
- Patients treated with amlitelimab-LD showed 80% improvement in
average EASI from baseline, and patients treated with
amlitelimab-HD showed 70% improvement in average EASI from
baseline, compared to 49% for the placebo group (p=0.009 and
p=0.072, respectively). The difference between amlitelimab-LD and
placebo was nominally statistically significant.
- The onset of response versus placebo was seen as early as Week
2 for both amlitelimab groups. No meaningful difference in
responses was seen for the amlitelimab-LD and amlitelimab-HD
groups.
- The overall rate of TEAEs was 35% for amlitelimab-LD, 17% for
amlitelimab-HD and 31% for placebo. One serious adverse event was
reported in the amlitelimab-LD group (infected atheroma) deemed
related by the investigator at week 16; the event was resolved, and
the patient was able to complete the study. No hypersensitivity
reactions were reported.
Also, at 16 weeks, key secondary endpoint data included:
- 44% of patients treated with amlitelimab-LD and 37% of patients
treated with amlitelimab-HD achieved a score of 0 (clear) or 1
(almost clear) on the validated Investigator's Global Assessment
(vIGA) scale compared with 8% with placebo (p<0.001 both LD and
HD). The vIGA is a 5-point scale ranging from 0 (clear) to 4
(severe) that measures the overall severity of skin lesions.
- 59% of amlitelimab-LD and 52% of amlitelimab-HD patients
achieved 75% or greater skin improvement (EASI-75) compared to 25%
with placebo.
- 33% of amlitelimab-LD and 30% of amlitelimab-HD patients
achieved 90% or greater skin improvement (EASI-790 compared to 13%
with placebo.
- A 60% improvement in the amlitelimab-LD group and a 59%
improvement in the amlitelimab-HD group compared with 37%
improvement in the placebo group in mean percent change from
baseline in SCORing Atopic Dermatitis (SCORAD), a combined measure
of area and severity of atopic dermatitis on the skin as well as
patient-reported symptoms of itch and sleeplessness, (p=0.011 and
p=0.016, respectively).
- At Week 36, 68% of patients who achieved a vIGA score of 0 or 1
at Week 16 maintained their response — 24 weeks after their last
dose.
“The amlitelimab data presented at EADV support
our belief that OX40-Ligand has the potential to provide a novel
approach to treating a range of immune-mediated diseases," said
Naimish Patel, M.D. Head of Global Development in Immunology and
Inflammation at Sanofi. "This Phase 2a trial is the foundation of
our clinical trial program with amlitelimab in atopic dermatitis.
The forthcoming global Phase 2b trial will further evaluate the
impact of amlitelimab when given subcutaneously in patients with
moderate-to-severe atopic dermatitis. The results from these two
trials will help form the basis for designing a phase 3 clinical
trial program to further evaluate the safety and efficacy of
amlitelimab."
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. By targeting
OX40-Ligand, amlitelimab aims to restore immune homeostasis between
pro-inflammatory and anti-inflammatory T cells.
Amlitelimab is being studied in patients with
moderate-to-severe atopic dermatitis with suboptimal response to
topical therapies. The potential for long-lasting treatment
responses in atopic dermatitis patients may help reduce the burden
of frequent dosing, and further investigation will be conducted in
a future Phase 2b study. Amlitelimab is currently under clinical
investigation, and its safety and efficacy have not been evaluated
by any regulatory authority.
In April 2021, Sanofi finalized the acquisition
of Kymab, a clinical-stage biopharmaceutical company developing
fully human monoclonal antibodies with a focus on immune-mediated
diseases and immuno-oncology therapeutics, adding amlitelimab to
the company’s dynamic pipeline.
About Sanofi
Sanofi is dedicated to supporting people through
their health challenges. We are a global biopharmaceutical company
focused on human health. We prevent illness with vaccines, provide
innovative treatments to fight pain and ease suffering. We stand by
the few who suffer from rare diseases and the millions with
long-term chronic conditions.
With more than 100,000 people in 100 countries,
Sanofi is transforming scientific innovation into healthcare
solutions around the globe.
Sanofi Media Relations Contact Sally BainTel.:
+1 (781) 264-1091Sally.Bain@sanofi.com
Sanofi Investor Relations Contacts Paris Eva
Schaefer-Jansen Arnaud Delepine Nathalie Pham
Sanofi Investor Relations Contact North America
Felix Lauscher
Tel.: +33 (0)1 53 77 45 45
investor.relations@sanofi.com
https://www.sanofi.com/en/investors/contact
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