Sanofi Drug Amlitelimab Succeeds in Phase 3 Atopic Dermatitis Trial
Positive late-stage study results bolster the potential of the novel OX40-ligand targeting antibody, positioning it as a future cornerstone treatment.
French pharmaceutical giant Sanofi announced a significant clinical victory as its investigational drug, amlitelimab, achieved all primary and secondary goals in a pivotal Phase 3 study for treating atopic dermatitis. The positive outcome marks a crucial step forward for a novel treatment that could offer a more convenient and effective option for millions suffering from the chronic skin condition.
The company confirmed that in the COAST 1 study, which enrolled adults and adolescents with moderate-to-severe atopic dermatitis. The drug demonstrated statistically significant and clinically meaningful improvements in skin clearance and disease severity compared to a placebo at the 24-week mark. Efficacy was shown to increase progressively throughout the treatment period, suggesting durable benefits for patients.
"These positive first phase 3 results of amlitelimab reinforce the potential of targeting the OX40-ligand to normalize the overactive immune system, without depleting T cells," said Houman Ashrafian, Executive Vice President and Head of Research & Development at Sanofi. He highlighted that the drug "may represent a significant advance in the treatment of atopic dermatitis with clinically meaningful and progressively increasing efficacy."
A key differentiator for amlitelimab is its unique mechanism of action and dosing schedule. The drug, a monoclonal antibody that blocks the OX40-ligand, aims to restore immune balance. The study results support the , a significant improvement in convenience over existing therapies that often require more frequent injections. Sanofi noted the drug was well-tolerated, with no new safety concerns identified.
The successful trial is a major boost for Sanofi's immunology pipeline. The full results from the COAST 1 study will be presented at an upcoming medical meeting. This is the first of several readouts from the broader OCEANA clinical development program, with , which will form the basis for global regulatory submissions. Beyond atopic dermatitis, Sanofi is exploring amlitelimab's potential in other immune-mediated conditions, including asthma, celiac disease, and alopecia areata.