Sanofi has announced positive results from a phase 2b trial of amlitelimab in adults with moderate-to-severe cases of atopic dermatitis, one of the most common inflammatory skin diseases.
Typically referred to as eczema, atopic dermatitis affects an estimated 16.5 million adults in the US, with nearly 40% affected by moderate-to-severe cases.
The disease causes itchy, red, swollen and cracked skin, usually affecting the folds of the arms, back of the knees, hands, feet, face and neck.
Sanofi’s amlitelimab is an investigational anti-OX40-ligand monoclonal antibody that is designed to rebalance the immune system by blocking inappropriate activation and proliferation of pro-inflammatory effector T cells and promoting expansion of anti-inflammatory regulatory T cells.
The company says the candidate “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.
The dose-ranging STREAM-AD study has been evaluating amlitelimab in adult patients whose disease was inadequately controlled with topical therapies or where such therapies were not advisable.
The study met its primary endpoint with amlitelimab-treated patients demonstrating statistically significant improvements from baseline at 16 weeks on the EASI test, which is used to measure the extent and severity of the condition, compared to placebo.
Improvements were also seen in key secondary outcome measures, the company said, and continued benefits were observed through week 24.
Naimish Patel, head of global development, immunology and inflammation at Sanofi, said: “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.”
The positive results for amlitelimab come just a few months after Sanofi and Regeneron’s Dupixent (dupilumab) was approved by the European Commission to treat severe atopic dermatitis in children aged six months to five years who are candidates for systemic therapy.
The approval made Dupixent the first targeted medicine in the EU for this patient population.