Biogen announced that its mid-stage monoclonal antibody litifilimab is showing promise in reducing joint pain related to systemic lupus erythematosus (SLE) lupus.
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Biogen announced that its mid-stage monoclonal antibody, litifilimab, is showing promise in reducing joint pain related to systemic lupus erythematosus (SLE) lupus.
Data from the two-part Phase II LILAC study highlighting the efficacy of litifilimab in lupus patients was published in The New England Journal of Medicine. Data from Part A of the LILAC study showed that after 24 weeks of treatment with litifilimab, SLE patients reported a reduction in the total number of swollen and tender joints compared to placebo.
Litifilimab, a humanized IgG1 monoclonal antibody targeting blood dendritic cell antigens (BDCA2), significantly reduced disease activity in people with SLE based on active joint count compared to placebo. SLE is associated with multiple symptoms, including rash, arthritis, anemia, thrombocytopenia, serositis, nephritis and seizures.
Through its ability to bind to BDCA2, litifilimab has been shown to reduce pro-inflammatory molecules that are expressed on plasmacytoid dendritic cells, including type 1 interferons. This inflammation is thought to play a significant role in lupus.
The Phase II trial was not powered to assess secondary endpoints.
Litifilimab was well-tolerated, with most adverse events considered mild or moderate. However, there is concern the monoclonal antibody could be related to the development of shingles, according to a report in Medical Xpress.
SLE causes chronic inflammation, pain and organ damage in afflicted patients. Treatment options for this form of lupus are limited, and the disease predominantly affects women and people of color who have been underrepresented in clinical research.
Last year, the FDA approved AstraZeneca’s Saphnelo for SLE. Saphnelo targets interferon 1, like litifilimab.
Biogen is currently enrolling patients with active SLE into two global Phase III studies: TOPAZ-1 and TOPAZ-2. It plans to initiate a pivotal study in cutaneous lupus erythematosus later this year.
SLE predominantly affects women and people of color. To that end, the company said enrollment targets have been set to “achieve appropriate representation of the African American and Hispanic/Latino communities.”
The most recent report follows a previous publication in NEJM that highlighted positive results from Part B of LILAC evaluating litifilimab in cutaneous lupus erythematosus (CLE). Biogen noted that both publications illustrate significant evidence that supports the continued development of litifilimab in lupus.
In both parts of the study, the primary endpoints were met, with litifilimab demonstrating superior efficacy to placebo. Litifilimab demonstrated efficacy in reducing total active joint count and improving skin disease activity in participants with SLE and CLE, respectively.
In a statement sent to BioSpace, Nathalie Franchimont, head of the multiple sclerosis and immunology development unit at Biogen, said the study enrolled a unique population of individuals with SLE who had both active arthritis and rash.
“We took an organ-specific approach with the LILAC study to investigate the efficacy and safety of litifilimab on both joints and skin manifestations of lupus based on the rationale that pDCs, the main cellular target of litifilimab, have been shown to be present in skin biopsies of patients with lupus and present in joints, and that both skin and joint manifestations are important and frequent components of the disease,” Franchimont said. “We are encouraged by the results of the LILAC study and look forward to progressing litifilimab into late-stage development and evaluating its potential to lessen the burden of disease for lupus patients, many of whom have historically been underserved.”
