The Lupus Research Alliance is encouraged by positive 52-week Phase 2 data (ongoing Phase 2/3 AMETHYST Study) with litifilimab, an investigational drug in development by Biogen. The data presented today at the 2026 EADV Congress in Vienna, Austria further supports its potential to achieve rapid and durable improvements in skin disease activity in adults with cutaneous lupus erythematosus.
“People living with cutaneous lupus erythematosus face debilitating symptoms, including scarring, hair loss, and extreme sensitivity to light, yet they have long relied on treatments not specifically developed or studied for CLE,” said Albert T Roy, President and CEO of the Lupus Research Alliance. “The new data on litifilimab are encouraging because they point to the potential for both rapid symptom relief and durable improvement for people living with this condition. We look forward to seeing additional data from the Phase 3 study.”
Litifilimab, a humanized IgG1 monoclonal antibody targeting BDCA2, received a Breakthrough Therapy Designation from the U.S. Food and Drug Administration in January 2026 based on results from the Phase 2 LILAC study.
Lupus Research Alliance clinical affiliate Lupus Therapeutics collaborated with Biogen on this clinical trial, ensuring the perspectives of people living with lupus were incorporated. Lupus Therapeutics is currently supporting the Phase 2/3 AMETHYST study.
Read the full press release from Biogen.
Tags: Biogen, Breakthrough Therapy Designation, litifilimab, AMETHYST