The New England Journal of Medicine Publishes Second Manuscript Reporting Positive Phase 2 Results for Biogen’s Litifilimab (BIIB059) in Lupus

• Part A results from the two-part Phase 2 LILAC study show litifilimab significantly reduced disease activity based on active joint count in people with systemic lupus erythematosus (SLE) compared to placebo
• Biogen is currently enrolling people with active SLE into two Phase 3 studies in 31 countries worldwide and plans to initiate a pivotal study in cutaneous lupus erythematosus (CLE) later this year
• Positive CLE results from Part B of LILAC were published separately in The New England Journal of Medicine, illustrating the body of evidence supporting the continued development of litifilimab for lupus

Excerpt from the Press Release:

CAMBRIDGE, Mass., Sept. 07, 2022 (GLOBE NEWSWIRE) — Biogen Inc. (Nasdaq: BIIB) today announced that The New England Journal of Medicine (NEJM) has published a second manuscript detailing positive results from the company’s two-part Phase 2 LILAC study, which evaluated litifilimab (also known as BIIB059), an investigational drug, in systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE). Results from the SLE portion of the study (Part A) published today show litifilimab met the study’s primary endpoint by significantly reducing total active joint count compared to placebo. Positive data from the CLE portion of the study were published in NEJM on July 28^th, 2022.

“Lupus is a debilitating autoimmune disease that causes chronic inflammation, pain and organ damage, and predominantly affects women and people of color,” said Richard Furie, M.D., The Marilyn and Barry Rubenstein Chair in Rheumatology, Chief of the Division of Rheumatology at Northwell Health and Professor at the Feinstein Institutes for Medical Research. “Litifilimab has been shown to inhibit the production of type I interferons as well as other inflammatory mediators produced by plasmacytoid dendritic cells. Strong evidence has accumulated that these mediators contribute to disease activity in lupus.”

Biogen is currently enrolling participants into the Phase 3 TOPAZ-1 and TOPAZ-2 studies, which will evaluate the efficacy and safety of litifilimab in participants with active SLE at 269 clinical trial sites worldwide. As part of Biogen’s commitment to delivering diversity in its clinical trials, enrollment targets have been set in the TOPAZ studies to achieve appropriate representation of the African American and Hispanic/Latino communities. Biogen also plans to initiate a pivotal study of litifilimab in CLE in 2022.

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