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Positive results for Biogen’s lupus drug published in NEJM

Around 90% of people with lupus are women, a condition for which there is currently no cure


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, assessing Biogen’s litifilimab – known as BIIB059 – an investigational drug developed to treat lupus.

Litifilimab – a humanised IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2 (BDCA2) – met its primary endpoint by showing superior efficacy to placebo in reducing skin disease activity.

BDCA2 is a receptor that is exclusively expressed on a subset of human immune cells known as Plasmacytoid Dendritic Cells (pDCs). It has been proven to reduce inflammatory production from pDCs, including type-I IFN (IFN-I), as well as other cytokines and chemokines. Such inflammatory mediators are believed to be key in the pathogenesis of systemic and cutaneous lupus.

The company has pushed litifilimab to the next phase in late-stage development and is enrolling participants with systemic lupus erythematosus (SLE) into the phase 3 TOPAZ-1 and TOPAZ-2 studies. Biogen plans to begin a pivotal study in CLE later this year.

“Litifilimab was developed by Biogen scientists as a potential first-in-class therapy for lupus,” said Nathalie Franchimont, head of the multiple sclerosis and immunology development unit at Biogen.

“This phase 2 data underscores 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.”

The LILAC study was a randomised, double-blind, placebo-controlled study evaluation of the efficacy and safety of litifilimab versus placebo, divided into two parts. Part A involved those who had SLE with active joint and skin manifestations, while part B involved those with moderate-to-severely active CLE, including active subacute and chronic subtypes, with or without systemic manifestations.

Both part A and part B of the study met the respective primary endpoints, with litifilimab providing superior efficacy compared to placebo in reducing total active joint count and improving skin disease activity in participants with SLE and CLE, respectively.

Part B of the LILAC study evaluated multiple doses of litifilimab or placebo in participants with active, histologically verified CLE.

CLE is a type of lupus and is a chronic autoimmune skin disease that can occur with or without systemic presentations. People living with CLE typically experience symptoms including rash, pain, pruritis (itching) and photosensitivity, on top of skin damage such as irreversible scarring alopecia and dyspigmentation that can be disfiguring and substantially impact quality of life.

Anyone can develop lupus, however, an estimated 90% of people living with lupus are women, with most experiencing symptoms between the ages of 15 to 40 years old. The condition disproportionately affects diverse ethno-racial groups, including African American, Asian, American Indian/Alaskan Native and Hispanic/Latino communities. There is currently no cure for lupus.

Article by
Fleur Jeffries

1st August 2022

From: Research, Healthcare



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