Biogen (BIIB) Reports Publication of Positive Phase 2 Data on Litifilimab

July 28, 2022 7:30 AM EDT

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Biogen Inc. (Nasdaq: BIIB) today announced that The New England Journal of Medicine (NEJM) has published positive results from the cutaneous lupus erythematosus (CLE) portion of the two-part Phase 2 LILAC study (Part B) evaluating litifilimab (known as BIIB059), an investigational drug for the treatment of lupus. Litifilimab met its primary endpoint by demonstrating superior efficacy to placebo in reducing skin disease activity.

“CLE can have a lasting negative impact on skin symptoms and emotional aspects of people’s lives, leading to a debilitating impact on quality of life and irreversible skin damage,” said Victoria Werth, M.S., M.D., Professor of Dermatology at the University of Pennsylvania’s Perelman School of Medicine. “Despite advancements over the past two decades, CLE represents a high unmet medical need with no cure. The LILAC study is among the first randomized controlled trials in CLE and I am encouraged by the publication of these positive results in NEJM.”

Biogen has progressed litifilimab to late-stage development and is actively enrolling participants with systemic lupus erythematosus into the Phase 3 TOPAZ-1 and TOPAZ-2 studies, with plans to initiate a pivotal study in CLE this year. Litifilimab has a novel mechanism of action that engages blood dendritic cell antigen 2 (BDCA2), a receptor solely expressed on the surface of plasmacytoid dendritic cells, resulting in decreased production of type 1 interferons, cytokines and chemokines at the site of inflammation such as the skin.1

“Litifilimab was developed by Biogen scientists as a potential first-in-class therapy for lupus,” said Nathalie Franchimont, M.D., Ph.D., Head of the Multiple Sclerosis and Immunology Development Unit at Biogen. “These Phase 2 data underscore our goal of delivering meaningful new therapies to people with cutaneous lupus, an autoimmune disease affecting the skin that can occur with or without impacting other organs, who currently have limited treatment options. We are excited to progress this promising candidate into late-stage development to further evaluate its potential, particularly in those who historically have been underserved.”

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