Sanofi says amlitelimab Phase 2b data show ‘potential best-in-class’ AD profile

Sanofi reports results from a Phase 2b study, STREAM-AD, showed that amlitelimab significantly improved signs and symptoms of moderate-to-severe atopic dermatitis or AD, in adults whose disease cannot be adequately controlled with topical medications or for whom topical medications are not a recommended treatment approach. These detailed results were presented today as part of a late-breaking session at the European Academy of Dermatology and Venereology, or EADV, 2023 Congress in Berlin. “The Phase 3 program for amlitelimab in atopic dermatitis is on track to start in the first half of 2024. This program is part of Sanofi’s immunology strategy built around exploring disruptive mechanisms of action designed to deliver first and best-in-class treatments for people living with chronic inflammatory diseases,” the company stated. Patients treated with amlitelimab experienced up to 61.5% improvement in average Eczema Area and Severity Index, or EASI, score from baseline at week 16, the primary endpoint, with continued improvement seen through 24 weeks. Clinically meaningful improvements were seen in all key secondary endpoints at week 16 with continued improvements through week 24, including for IGA 0/1 where patients on the highest dose experienced 22.1% improvement at week 16 which increased to 45.5% by week 24. Houman Ashrafian, M.D., Ph.D., Global Head of Research & Development, Sanofi, said: “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.”