Biogen announced on Mar. 30 that its experimental drug litifilimab reduced disease activity in cutaneous lupus erythematosus (CLE) during a second mid-stage study, marking another step forward for the company's immunology and inflammation pipeline, according to analysts at RBC Capital Markets.
This development is significant as CLE is a serious autoimmune condition that can cause skin rashes leading to permanent scarring and disfigurement. Diana Gallagher, senior vice president of Biogen’s Multiple Sclerosis and Immunology Disease Unit and Alzheimer’s and Dementia Disease Unit, said the company has focused on understanding the biology behind CLE for several years.
In the Phase 2/3 AMETHYST trial, litifilimab—also known as liti—met its primary endpoint by achieving an 11.8% higher reduction in disease activity compared to placebo at week 16. Specifically, Biogen reported that 14.7% of patients treated with liti reached clear or almost clear skin status versus just 2.9% on placebo at the American Academy of Dermatology Annual Meeting. The treatment also showed rapid improvement from as early as week four through week twenty-four when measured by another clinical index.
Gallagher noted that these results back up earlier findings from a previous successful Phase 2 trial called LILAC, where liti demonstrated consistent benefit over placebo for CLE patients. She said a one-year Phase 3 study is expected to produce topline data later next year which will help “fully characterize safety and tolerability, time to effect and durability.”
If approved, litifilimab would be the first targeted therapy for CLE in seventy years according to Biogen. The company has also placed liti into two additional late-stage trials for systemic lupus erythematosus (SLE), with further data expected soon.
Looking ahead, analysts say these upcoming readouts could provide important catalysts for Biogen’s future growth amid increasing pressure on its multiple sclerosis portfolio.
