Biogen's Litifilimab Shows Durable CLE Benefits at 52 Weeks
New Phase 2 data show Biogen's litifilimab sustained skin disease improvements through one year in cutaneous lupus patients.
Biogen Inc. on Thursday reported 52-week results from the Phase 2 portion of its ongoing AMETHYST Phase 2/3 trial evaluating litifilimab in patients with cutaneous lupus erythematosus (CLE), a chronic autoimmune condition that primarily affects the skin. The data, presented at the European Academy of Dermatology and Venereology Congress in Vienna, represent the longest published dataset for the experimental drug in this indication.
Patients who received litifilimab during the double-blind, placebo-controlled period of the study showed sustained reductions in skin disease activity through the full 52-week observation window, according to the Cambridge, Massachusetts-based company. The findings reinforce the drug's profile as a potential first-in-class therapy for CLE, a disease with limited approved treatment options.
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A notable finding involved participants who had initially been assigned to placebo and then crossed over to active treatment at Week 24. Those patients experienced a measurable onset of clinical benefit as early as four weeks after switching, suggesting a relatively rapid mechanism of action for the antibody therapy.
The AMETHYST study continues into a Phase 3 portion, and Thursday's readout adds to the accumulating body of evidence Biogen is assembling ahead of potential regulatory submissions. Analysts have watched litifilimab closely as a meaningful pipeline asset for the company, which trades on Nasdaq under the ticker BIIB.
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