- 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
BiogenInc.( Nasdaq BIIB) moment blazoned that The New England Journal of Medicine( NEJM) has published a alternate handwriting detailing positive results from the company’s two- part Phase 2 LILAC study, which estimated litifilimab( also known as BIIB059), an investigational medicine, in systemic lupus erythematosus( SLE) and cutaneous lupus erythematosus( CLE). Results from the SLE portion of the study( Part A) published moment show litifilimab met the study’s primary endpoint by significantly reducing total active common count compared to placebo. Positive data from the CLE portion of the study were published in NEJM on July 28th, 2022.
“ Lupus is a enervating autoimmune complaint that causes habitual inflammation, pain and organ damage, and generally 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 product of type I interferons as well as other seditious intercessors produced by plasmacytoid dendritic cells. Strong substantiation has accumulated that these intercessors contribute to complaint exertion in lupus. ”
Biogen is presently enrolling actors into the Phase 3 TOPAZ- 1 and TOPAZ- 2 studies, which will estimate the efficacity and safety of litifilimab in actors with active SLE at 269 clinical trial spots worldwide. As part of Biogen’s commitment to delivering diversity in its clinical trials, registration targets have been set in the TOPAZ studies to achieve applicable representation of the African American and Hispanic/ Latino communities. Biogen also plans to initiate a vital study of litifilimab in CLE in 2022.
“ This alternate NEJM handwriting shows the summation of data from the Phase 2 LILAC program, buttressing our belief in the eventuality of litifilimab as a first- in- class remedy for both systemic and cutaneous lupus, ” said Nathalie Franchimont,M.D.,Ph.D., Head of the Multiple Sclerosis and Immunology Development Unit at Biogen. “ At Biogen, our thing is to discover and develop new treatment options that not only reduce lupus complaint exertion but also drop clinical instantiations that impact cases the most. We look forward to continuing our evaluation of litifilimab in Phase 3 studies and participating fresh data when available. ”
The Phase 2 LILAC Part A Results
LILAC was a randomized, double-eyeless, placebo- controlled study that estimated the efficacity and safety of litifilimab versus placebo in two corridor Part A in actors who had SLE with active joint and skin instantiations; and Part B in actors with moderate- to-severe active CLE, including active subacute and habitual subtypes, with or without systemic instantiations. As preliminarily reported, both Part A and Part B of the study met their separate primary endpoints, with litifilimab demonstrating superior efficacity to placebo in reducing total active common count and perfecting skin complaint exertion in actors with SLE and CLE, independently.
In Part A of LILAC, litifilimab significantly reduced the total number of blown and tender joints in actors with SLE from birth compared to placebo over 24 weeks. This Phase 2 trial wasn’t powered to assess secondary endpoints.
In Part A, litifilimab was generally well permitted, with utmost reported adverse events( AEs) rated as mild or moderate. The most common AEs reported in ≥ 5 of actors in the pooled litifilimab groups were diarrhea, nasopharyngitis, urinary tract infection, fall and headache.
About Litifilimab( BIIB059)
Litifilimab( known as BIIB059), discovered and developed in- house by Biogen scientists, is a humanized IgG1 monoclonal antibody( mAb) targeting blood dendritic cell antigen 2( BDCA2) and is being delved for the implicit treatment of systemic lupus erythematosus( SLE) and cutaneous lupus erythematosus( CLE). BDCA2 is a receptor that’s simply expressed on a subset of mortal vulnerable cells called Plasmacytoid Dendritic Cells( pDCs). List of litifilimab to BDCA2 has been shown to reduce product ofpro-inflammatory motes by pDCs, including type- I interferon( IFN- I) as well as other cytokines and chemokines.1, 2 Thesepro-inflammatory intercessors are allowed
to play a major part in the pathogenesis of systemic and cutaneous lupus.
About Systemic Lupus Erythematosus( SLE)
SLE, the systemic form of lupus, is a habitual autoimmune complaint that affects multiple organ systems with ages of illness or flares interspersing with ages of inactivity.3 SLE can present itself in several ways including rash, arthritis, anemia, thrombocytopenia, serositis, nephritis, seizures or psychosis.4 SLE is associated with a lesser threat of death from causes similar as infection and cardiovascular complaint.
Lupus affects an estimated 5 million people worldwide.5 An estimated 90 percent of people living with lupus are women; most begin to see symptoms between the periods of 15-40.6 The complaint disproportionately impacts different ethno- ethnical groups, including African American, Asian, American Indian/ Alaskan Native and Hispanic/ Latinocommunities.6- 10 There’s presently no cure for lupus.
As settlers in neuroscience, Biogen discovers, develops, and delivers worldwide innovative curatives for people living with serious neurological conditions as well as affiliated remedial closeness. One of the world’s first global biotechnology companies, Biogen was innovated in 1978 by Charles Weissmann, Heinz Schaller, Sir Kenneth Murray, and Nobel Prize winners Walter Gilbert and Phillip Sharp. moment, Biogen has a leading portfolio of drugs to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, and developed the first and only approved treatment to address a defining pathology of Alzheimer’s complaint. Biogen is also commercializing biosimilars and fastening on advancing one of the assiduity’s most diversified channels in neuroscience that will transfigure the standard of care for cases in several areas of high unmet need.