What's Happening?
Sanofi's investigational OX40L blocker, amlitelimab, showed disappointing results in a Phase III study for atopic dermatitis. Analysts noted that its efficacy was inferior to Dupixent, a leading anti-inflammatory biologic. The study involved over 600 patients and measured the EASI-75 endpoint, indicating a 75% improvement in eczema severity. Amlitelimab achieved 35.9% and 39.1% EASI-75 at different dosing intervals, compared to placebo results of 19.1%. Analysts suggest OX40-targeting therapies may not drive deep responses as fast as IL-13/4 class therapies, potentially relegating them to second-line treatments.
Why It's Important?
The underperformance of amlitelimab highlights challenges in developing effective treatments for atopic dermatitis, a common skin condition. Dupixent remains the benchmark for efficacy, and the results may impact Sanofi's position in the dermatology market. The findings suggest limitations in OX40-targeting therapies, affecting their potential as first-line treatments. This could influence future research directions and investment in similar biologics. The dermatology field may see shifts in treatment strategies, with a focus on more effective pathways like IL-13/4 targeting.
What's Next?
Sanofi continues to explore amlitelimab in other trials within its OCEANA program, including SHORE, COAST-2, AQUA, and ESTUARY. Data from these trials, expected in 2026, may support global regulatory submissions. The company aims to refine its approach and potentially improve outcomes in future studies. Analysts and investors will closely monitor these developments, assessing the viability of OX40-targeting therapies in the competitive dermatology market.
