Biogen Presents Positive Phase 2 Cutaneous Lupus Erythematosus (CLE) Data at European E-Congress of Rheumatology (EULAR) 2020

• Full analysis of the CLE part of the LILAC study reinforces positive top-line results; participants who received BIIB059 (anti-BDCA2) demonstrated statistically significant reduction of disease activity compared to those who received placebo
  
• Safety and tolerability data further support the continued development of BIIB059
• Results underscore Biogen’s efforts to develop and deliver novel disease-modifying therapeutic options for people impacted by lupus, a chronic autoimmune disease characterized by skin lesions and/or systemic manifestations

CAMBRIDGE, Mass., June 04, 2020 (GLOBE NEWSWIRE) -- Today, Biogen Inc. (Nasdaq: BIIB) shared positive data from the 16-week cutaneous lupus erythematosus (CLE) portion of the Phase 2 LILAC study. The study evaluated the efficacy and safety of BIIB059, a fully humanized IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2 (BDCA2) expressed on plasmacytoid dendritic cells (pDCs). The data were presented at the European E-Congress of Rheumatology (EULAR) 2020, being held virtually from June 3-6, 2020.

“We are encouraged by the CLE results from the BIIB059 Phase 2 lupus study presented at the 2020 virtual EULAR congress,” said Nathalie Franchimont, M.D., Ph.D., vice president of the multiple sclerosis and immunology development unit at Biogen. “These data underscore our goal of delivering meaningful new therapies to people living with lupus, who currently have limited treatment options.”

The CLE part of the LILAC study met its primary endpoint (p<0.001) by demonstrating a dose response of BIIB059 on the percent change from baseline in the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score at week 16 in people with CLE. Study participants with CLE that received 50 mg, 150 mg and 450 mg of BIIB059 experienced reductions in CLASI-A scores of 38.8 percent (p=0.015), 47.9 percent (p<0.001) and 42.5 percent (p=0.001), respectively, versus 14.5 percent with placebo. CLASI-A is a well-defined and reliable outcome measure that has been shown to detect change in CLE skin disease activity.

With respect to the secondary endpoint of CLASI-50 response, statistical significance was achieved in study participants who received 450 mg of BIIB059; 23.3 percent (p=0.024) more participants achieved CLASI-50 response versus placebo. While not statistically significant, more participants treated with BIIB059 50 mg (15.8 percent) and 150 mg (21.2 percent) achieved a CLASI-50 response versus placebo. A CLASI-50 response is defined as a 50 percent improvement from baseline in CLASI-A score.