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-AD
STREAM-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.
|
|
|
|
|
2/3 |