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Biogen to Present New Late-Breaking Litifilimab Phase 2 AMETHYST Data in Cutaneous Lupus Erythematosus at 2026 American Academy of Dermatology Annual Meeting
Late-breaking AMETHYST Part A study results to be presented, showing safety and efficacy of litifilimab in cutaneous lupus erythematosus (CLE)Litifilimab was
About this update from Biogen Inc.
[{"type":"text","content":"Late-breaking AMETHYST Part A study results to be presented, showing safety and efficacy of litifilimab in cutaneous lupus erythematosus (CLE)Litifilimab was recently granted Breakthrough Therapy Designation by the FDA for CLE; AMETHYST Part A results supported the designationCLE is a serious autoimmune disease that impacts the daily lives of patients and can lead to permanent scarring and disfigurement when left untreated, and has no targeted treatment option CAMBRIDGE, Mass., March 19, 2026 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced upcoming scientific presentations at the 2026 American Academy of Dermatology (AAD) Annual Meeting, taking place March 27-31. Late-breaking data from Part A (Phase 2) of the AMETHYST Phase 2/3 study will be presented that highlight litifilimab’s effect on cutaneous lupus erythematosus (CLE) disease activity. Litifilimab is a potential first in-class, monoclonal antibody (mAb) targeting blood dendritic cell antigen 2 (BDCA2) and was the first investigational therapy to show positive results in CLE, as shown in the Phase 2 LILAC study. Additional presentations at AAD will provide new insights into measures used to assess the severity of CLE disease activity in both clinical trials and clinical practice. “The data we are presenting at AAD reflect Biogen’s decades of investment in cutaneous lupus, a disease that extends far beyond the skin, significantly impacting the daily lives and mental health of people living with this disease, and often leading to permanent scarring,” said Diana Gallagher, MD, Senior Vice President and Head of AD, MS and Immunology Development Units at Biogen. “We look forward to sharing the Phase 2 results from AMETHYST that show the potential of litifilimab in CLE. The Phase 3 part of the study, which will further evaluate litifilimab in CLE, is on track and a data readout is expected in 2027.” Earlier this year, the U.S. Food and Drug Administration granted litifilimab Breakthrough Therapy Designation for CLE. Results from the Phase 2 (Part A) part of the AMETHYST study supported the designation, in addition to the previously presented Phase 2 LILAC study results. Details of the presentations at AAD are as follows: Late-Breaking Oral Presentation “Efficacy and Safety of Litifilimab in Cutaneous Lupus Erythematosus (CLE): 24-week results of the Phase 2 Study...