Anthera Completes Enrollment For Phase 3 Clinical Trial of Blisibimod

Ines Martins, PhD avatar

by Ines Martins, PhD |

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Anthera Pharmaceuticals recently announced it has completed the enrolment of patients for its CHABLIS-SC1 Phase 3 study evaluating blisibimod as a lupus treatment. The company expects to have final data from the trial by the end of 2016.

“Reaching our enrollment target for CHABLIS-SC1 ahead of schedule is an important accomplishment,” said in a recent press release Dr. Colin Hislop, MD, Anthera’s Chief Medical Officer. “The accelerated pace speaks to the importance of patient identification and selection in lupus treatment. In addition, the wealth of new information released over the past year regarding the treatment of Systemic Lupus Erythematosus (SLE) and BAFF inhibition has demonstrated that patients with more severe disease, such as those enrolled in the CHABLIS-SC1 trial, are more likely to respond to a BAFF therapy. We look forward to the culmination of our efforts in CHABLIS-SC1 next year as we continue the development of blisibimod.”

Data obtained from the CHABLIS-SC1 and CHABLIS-SC2 clinical trials should support the marketing approval for blisibimod as a treatment option for patients with active SLE that do not respond to traditional treatment strategies, including corticosteroids.

SLE (lupus) is an autoimmune disorder that involves inflammation that causes swelling, pain and tissue damage throughout the body. Lupus can affect any part of the body, but particularly the skin, heart, brain, lungs, joints and kidneys. The course of the disease is unpredictable, with periods of illness (called flares) alternating with remission. Patients with active lupus may have a broad range of symptoms related to inflammation.

Blisibimod is a selective peptibody antagonist of the BAFF cytokine (a tumor necrosis family member essential for the development, maintenance and survival of B-cells) being developed as a treatment for lupus. Evidence has emerged that over-expression of BAFF plays an important role in this disease process. In preclinical studies, transgenic mice created to over-express BAFF exhibit symptoms similar to lupus. In addition, treatment of these mice with BAFF antagonists appears to ameliorate the disease.