Atopic Dermatitis Supported by Novel Monoclonal Antibody

Sanofi - Aventis Groupe today announced positive topline Phase 2b clinical data in atopic dermatitis support amlitelimab as a potential first and best-in-class novel investigational anti-OX40-ligand monoclonal antibody.

The primary endpoint was met in the Phase 2b study (STREAM-AD) of amlitelimab in adults with moderate-to-severe atopic dermatitis whose disease cannot be adequately controlled with topical medications or for whom topical medications are not a recommended treatment approach.

Amlitelimab is a fully human non-depleting monoclonal antibody that binds to OX40-Ligand, a key immune regulator.

It can be a first-in-class treatment for various immune-mediated diseases and inflammatory disorders, including moderate-to-severe atopic dermatitis and asthma.

By targeting OX40-Ligand, amlitelimab aims to restore immune homeostasis between pro-inflammatory and regulatory T cells.

Naimish Patel, M.D., Head of Global Development, Immunology and Inflammation, Sanofi, commented in a press release on June 27, 2023, "While we have made significant strides in the treatment of atopic dermatitis, there are patients who are still in need of new options."

"We believe that the results from this Phase 2b study with amlitelimab support our perspective that targeting OX40-Ligand has the potential to provide a first and best-in-class treatment option that addresses type 2 and non-type 2 inflammation to meet the individual needs of people living with atopic dermatitis and other chronic inflammatory diseases."

"We look forward to advancing into a larger Phase 3 clinical development program and continuing to drive momentum in our Immunology pipeline to deliver first or best-in-class treatments."

In this dose-ranging study, treatment with amlitelimab resulted in statistically significant improvements in average Eczema Area and Severity Index score from baseline at 16 weeks compared to placebo for all four subcutaneous doses that were studied.

There were also improvements in key secondary outcome measures, and continued improvements were observed through week 24 in primary and key secondary outcomes.

Biomarker results support an effect on both type 2 and non-type 2 pathways.

Amlitelimab was well-tolerated in the study across all dose arms, and no new safety concerns were identified.

Furthermore, Amlitelimab is under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority.

The U.S. NIH says atopic dermatitis, often referred to as eczema, is a chronic (long-lasting) disease that causes inflammation, redness, and irritation of the skin. It is a common condition that usually begins in childhood.

However, anyone can get the disease at any age.

And atopic dermatitis is not contagious, so it cannot be spread from person to person.