2019-12-18| R&DTrials & Approvals

Biogen’s BIIB059 May End a 10-Year Drought with New Lupus Drug

by GeneOnline
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Biogen gradually sees the potential for a new lupus drug after a series of clinical setbacks and challenges with existing drug making for multiple sclerosis and spinal muscle atrophy. Biogen deemed itself as the pioneers in neuroscience by discovering, developing and delivering worldwide innovative therapies for people living with severe neurological and neurodegenerative diseases. Founded in 1978, Biogen is one of the world’s first global biotechnology companies and remains a leader in multiple sclerosis and spinal muscular atrophy treatments.

However, with the growing competition on commercializing neural disease treatments, Biogen extends its pharmacological influential to fight against immune diseases, an extremely specialized area for neuroscience drugs. Recently, Biogen launched Phase 2 LILAC study assessing the safety and efficacy of BIIB059 to treat lupus. Results showed positive topline results for a study including 264 individuals with active cutaneous lupus erythematosus (CLE) or systemic lupus erythematosus (SLE). BIIB059 is an IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2 (BDCA2) for potential treatment of CLE and SLE. BDCA2, a receptor expressing many types of human immune cells known as Plasmacytoid Dendritic Cells (pDCs), can reduce inflammatory cytokine production from pDCs and other inflammatory factors that induce pathogenesis of lupus.

Shifting from a focus on neuro-related diseases to autoimmune diseases, Biogen takes both a risk and makes a practical decision because very few treatment options have been approved by the FDA. In fact, the last approved drug GlaxoSmithKline’s Benlysta (belimumab) was in 2011 and “became the market-leading drug for lupus with sales of $575 million USD last year.” Precisely because very few drugs are currently approved for lupus treatment and Biogen’s LILAC trial on BIIB059 testing showed positive results, Biogen diverts its attention to neural drug research and may actually rescue itself from the fierce commercial competition. Becoming the latest developer of a lupus treatment would not only leave Biogen with fewer competitors but likely increased finances.


Lupus – Cutaneous vs. Systemic Lupus Erythematosus

Lupus is a disease “in which the immune system attacks normal cells and tissues, causing inflammation and organ damage, particularly affecting the skin and joints.” The two types of lupus targeted in the LILAC study are the CLE and SLE. CLE is “a chronic autoimmune disease where the body’s immune system attacks healthy skin, often causing rashes and skin lesions…[and is] associated with a decrease in quality of life and increased depression.” SLE is a chronic autoimmune disease that affects multiple organ systems, with periods of illness or flares alternating with periods of remission… [and] associated with a greater risk of death from causes such as infection and cardiovascular disease.” SLE can present in several ways, including: rash, anemia, serositis, nephritis, seizures, psychosis, thrombocytopenia, and arthritis. Although SLE has more life threatening symptoms than CLE, both autoimmune disorders significantly decrease the quality of life for its victims.


Phase 2 LILAC Study – Evaluation of Efficacy & Safety of BIIB059 to CLE & SLE

The Phase 2 LILAC study is a randomized, double-blinded, placebo-controlled study to evaluate BIIB059 versus placebo in individuals with active CLE (including chronic and subacute subtypes) and with SLE. The significance of BIIB059 is based upon the percent change from baseline in the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 16 for CLE participants, while the number change from the baseline in total active joint count at Week 24 for SLE’s. The study participants with CLE treated with 50mg, 150mg and 450mg of BIIB059 “experienced reductions in CLASI-A scores of 40.9% (p=0.008), 48% (p=0.001) and 42.5% (p=0.001), respectively, versus 14.5% with placebo.” For the SLE participants, the results show that those receiving BIIB059 had 3.4 fewer tender or swollen joints than those receiving placebo. Nevertheless, much research is required to further demonstrate BIIB059’s safety, as the BIIB059 relevant documents present a conservative tone in regards to the drug’s risks and other uncertainties. Still, the news of BIIB059 is met with an optimistic view by Nathalie Franchimont, M.D., Ph.D., Vice President of Lupus and Multiple Sclerosis Portfolio at Biogen. “There is substantial unmet medical need for people with lupus given the limited number of treatment options available to help manage this difficult-to-treat and chronic disease.”

Edit/ Judy Ya-Hsuan Lin





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