The Lupus Research Alliance welcomes new results from the Phase 2 part of the AMETHYST Phase 2/3 study, showing that the investigational litifilimab in development by Biogen significantly reduced skin disease activity in cutaneous lupus erythematosus (CLE). These data were presented at the American Academy of Dermatology Annual Meeting on March 28 in Cambridge, MA.
In the AMETHYST trial, litifilimab achieved an 11.8% higher reduction in disease activity among people living with CLE than those who were given standard of care. Also of note, one in six people who received litifilimab showed clear or almost clear skin. This follows the recent news that the U.S. Food and Drug Administration (FDA) recently granted Breakthrough Therapy designation for litifilimab as a potential treatment for CLE.
With no specifically approved treatment, CLE primarily causes inflammation of the skin. Symptoms vary, but can include butterfly rashes, ring-shaped sores, or red, scaly patches on the skin. CLE can cause irreversible scarring, skin pigment changes, and hair loss – significantly impacting quality of life. Clinical affiliate Lupus Therapeutics has collaborated with Biogen on Phase 2 and 3 clinical trials investigating litifilimab, ensuring the perspectives of people living with lupus are incorporated throughout the drug development process.
Tags: Biogen, litifilimab, AMETHYST, American Academy of Dermatology, lupus therapeutics