Sanofi’s phase 3 program for amlitelimab in atopic dermatitis will start in early 2024.
Sanofi announced today positive data from its phase 2b study, STREAM-AD (NCT05131477), of amlitelimab significantly improving signs and symptoms of moderate to severe atopic dermatitis (AD) in adults whose AD cannot be managed with topical medications or for whom topical medications are not recommended. The late-breaking data was presented at the European Academy of Dermatology and Venereology (EADV) 2023 Congress in Berlin, Germany. Based on these results, Sanofi’s phase 3 program for amlitelimab in atopic dermatitis will start in early 2024.1
Key findings from the study include:
Overall, amlitelimab was well-tolerated across all dose arms and no new safety signals were reported. The total rates of treatment-emergent adverse events (TEAEs) were 67.4% for amlitelimab and 60.3% for placebo. TEAEs more commonly associated with amlitelimab compared to placebo were nasopharyngitis (11.0% amlitelimab, 9.0% placebo), COVID-19 (7.7% amlitelimab, 6.4% placebo) and headache (6.1% amlitelimab, 2.6% placebo). In the placebo group (38.5%), the worsening of AD was more common compared to amlitelimab (17.1%). No adverse events such as fever or chills, oral ulcers, or imbalances with conjunctivitis were reported.
“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,” said Naimish Patel, MD, the head of global development for immunology and inflammation at Sanofi, in the news release.
Amlitelimab is a fully human non-depleting monoclonal antibody that binds to OX40-Ligand, and according to Sanofi, has the potential to be a first-in-class treatment for a range of immune-mediated diseases and inflammatory disorders such as moderate to severe AD and asthma. Amlitelimab may be able to restore balance between pro-inflammatory and regulatory T cells by targeting OX40-Ligand.