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Biogen Presents Positive Phase 2 Cutaneous Lupus Erythematosus (CLE) Data at European E-Congress of Rheumatology (EULAR) 2020
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. The majority of adverse events in the LILAC study were mild or moderate and the incidence of serious adverse events was 7.1 percent versus 9.1 percent in participants that received BIIB059 versus placebo. Rate of infections was 34.3 percent versus 30.3 percent in participants that received BIIB059 versus those given placebo; no significant increased risk of infection has been identified. Eight participants, who all received BIIB059, discontinued study drug due to side effects. Overall, the safety and tolerability results further support the continued development of BIIB059. LILAC was a randomized, parallel, double-blind, placebo-controlled two-part study that evaluated BIIB059 versus placebo in participants with active CLE, including chronic and subacute subtypes, with or without systemic manifestations and in participants with systemic lupus erythematosus (SLE) with active joint and skin manifestations. Final results from the SLE part of the LILAC study will be presented at a future medical congress. About BIIB059 About the Phase 2 LILAC Study The CLE part of the study, which enrolled 132 participants, investigated either a BIIB059 50 mg, 150 mg or 450 mg dose administered subcutaneously every 4 weeks with an additional dose at week 2 versus placebo in participants with active CLE. The primary endpoint was dose-response of BIIB059 as measured by percent change from baseline in the CLASI-A Score at Week 16. About Cutaneous Lupus Erythematosus (CLE) About Biogen We routinely post information that may be important to investors on our website at www.biogen.com. To learn more, please visit www.biogen.com and follow us on social media – Twitter, LinkedIn, Facebook, YouTube. Biogen Safe Harbor Statement These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation risks relating to uncertainty of success in the development and potential commercialization of BIIB059; the occurrence of adverse safety events and/or unexpected concerns that may arise from additional data or analysis; failure to obtain regulatory approvals; risks of unexpected hurdles, costs or delays; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; regulatory authorities may require additional information or further studies or may fail or refuse to approve or may delay approval of our drug candidates, including BIIB059; product liability claims; and the direct and indirect impacts of the ongoing COVID-19 pandemic on our business, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in our most recent annual or quarterly report and in other reports we have filed with the U.S. Securities and Exchange Commission. These statements are based on our current beliefs and expectations and speak only as of the date of this news release. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
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