Source – Sanofi
On June 27, 2023, Sanofi announced positive Phase IIb Results. Amlitelimab shows promise as a first-in-class investigational Anti-OX40-Ligand monoclonal antibody for atopic dermatitis.
A significant milestone has been achieved in the Phase IIb study (STREAM-AD) of amlitelimab, conducted among adults with moderate-to-severe atopic dermatitis. This study targeted patients who either had insufficient control over their condition with topical medications or for whom topical treatments were not recommended.
“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 IIb 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 II and non-type II inflammation to meet the individual needs of people living with atopic dermatitis and other chronic inflammatory diseases. Continuing to drive momentum in our Immunology pipeline to deliver first or best-in-class treatments.”
– Naimish Patel, M.D, Head of Global Development, Immunology and Inflammation, Sanofi
During this dose-ranging study, amlitelimab demonstrated notable improvements in the average Eczema Area and Severity Index (EASI) score compared to placebo after 16 weeks of treatment. The improvements were statistically significant across all four subcutaneous doses investigated. Encouragingly, key secondary outcome measures also exhibited positive trends, and the improvements continued up to week 24 for both primary and key secondary outcomes. Biomarker results further supported the impact of amlitelimab on both type II and non-type II pathways, adding to its potential therapeutic value.
Throughout the study, amlitelimab exhibited favorable tolerability across all dosage arms, with no new safety concerns identified.
Amlitelimab is a fully human, non-depleting monoclonal antibody that selectively binds to OX40-Ligand, a vital regulator of the immune system. It holds the potential to be a groundbreaking treatment option 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 by balancing pro-inflammatory and regulatory T cells.
Detailed efficacy and safety findings from this trial will be presented in a forthcoming scientific forum. It is important to note that amlitelimab is currently undergoing clinical investigation, and its safety and effectiveness have not yet been evaluated by any regulatory authority.