A two-part Phase 2 clinical trial, LILAC, evaluating Biogen’s (NASDAQ:BIIB) BIIB059 in patients with cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) met the primary endpoints demonstrating a statistically significant reduction in disease activity compared to placebo.
The CLE part met the primary objective showing a statistically significant dose response as measured by the change from baseline in a scale called CLASI-A at week 16 compared to control. Specifically, participants receiving 50 mg, 150 mg and 450 mg of BIIB059 experienced CLASI-A reductions of 40.9%, 48.0% and 42.5%, respectively, compared to a 14.5% reduction in the placebo arm.
The SLE part also met the primary endpoint, demonstrating a statistically valid reduction in disease activity as measured by the change from baseline in total active joint count at week 24 versus placebo (-3.4 for the 450 mg dose; p=0.037).
On the safety front, the company says BIIB059’s safety and tolerability profile “supports its continued development.”
Detailed results will be submitted for presentation at a future medical conference.
BIIB059 is fully humanized IgG1 monoclonal antibody that targets a molecule called blood dendritic cell antigen 2 (DDCA2) expressed on a rare type of immune cell called plasmacytoid dendritic cells.
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