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 –
"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
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
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 averageEASI 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
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
About
With more than 100,000 people in 100 countries,
Sanofi Media Relations Contact
Tel.: +1 (781) 264-1091
Sally.Bain@sanofi.com
Sanofi Investor Relations Contacts Paris
Sanofi Investor Relations Contact
Tel.: +33 (0)1 53 77 45 45
investor.relations@sanofi.com
https://www.sanofi.com/en/investors/contact
Sanofi Forward-Looking Statements
This 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 regarding the marketing and other potential of the product, or regarding potential future revenues from the product. 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
Attachment
© OMX, source