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Biogen Announces First Patient Dosed in Phase 3 Systemic Lupus Erythematosus Study
Global Phase 3 TOPAZ-1 study will evaluate the efficacy and safety of BIIB059, as compared to placebo, in active systemic lupus erythematosus (SLE), a
About this update from Biogen Inc.
[{"type":"text","content":"Global Phase 3 TOPAZ-1 study will evaluate the efficacy and safety of BIIB059, as compared to placebo, in active systemic lupus erythematosus (SLE), a debilitating autoimmune disease which has limited treatment optionsPositive Phase 2 LILAC study efficacy results support the further evaluation of BIIB059 in SLE CAMBRIDGE, Mass., June 17, 2021 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the first patient has been dosed in the global clinical study, TOPAZ-1. The Phase 3 study will evaluate the clinical efficacy and assess the safety of BIIB059, a first in-class, humanized IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2 (BDCA2), as compared to placebo, in participants with active systemic lupus erythematosus (SLE). TOPAZ-1 is expected to be conducted at approximately 135 sites worldwide and aims to enroll 540 adults with active SLE. “A chronic autoimmune condition such as lupus, which overwhelmingly affects women, has a tremendous impact on my patients’ daily lives, including their physical, mental and social wellbeing,” said Richard Furie, M.D., Chief of the Division of Rheumatology at Northwell Health and Professor at Zucker School of Medicine at Hofstra/Northwell. “There remains a significant need for efficacious and generally safe treatment options for lupus patients. Based on the positive results observed in the Phase 2 LILAC study, we are excited to continue to evaluate the potential of BIIB059 in TOPAZ-1.” TOPAZ-1 is a 52-week, multicenter, randomized double-blind, placebo-controlled Phase 3 study to evaluate the efficacy and safety of BIIB059 compared with placebo. Participants will be randomized to receive subcutaneous treatment with BIIB059 at one of two doses or placebo every four weeks with an additional dose at Week 2, in addition to their existing lupus therapy. “We look forward to working with the lupus community as we advance the clinical development of BIIB059 with the hope of bringing a meaningful new treatment option to people living with systemic and cutaneous lupus,” said Nathalie Franchimont, M.D., Ph.D., Head of the Multiple Sclerosis and Immunology Development Unit at Biogen. “Additionally, we are reinforcing Biogen’s commitment to the inclusion of underrepresented groups in our clinical trials. We have set enrollment targets that reflect the prevalence of SLE ...