Biogen's Litifilimab Shows Durable CLE Results at 52 Weeks
New Phase 2 data from Biogen's AMETHYST study show litifilimab sustaining skin improvements through one year in cutaneous lupus patients.
Biogen Inc. announced 52-week results from the Phase 2 portion of its ongoing AMETHYST Phase 2/3 clinical trial evaluating litifilimab as a treatment for cutaneous lupus erythematosus, a chronic autoimmune skin disease. The data, presented at the European Academy of Dermatology and Venereology Congress in Vienna, Austria, mark the longest reported dataset for the experimental therapy in this indication.
Patients who received litifilimab throughout the double-blind, placebo-controlled segment of the study continued to show measurable reductions in skin disease activity through the 52-week mark, according to the Cambridge, Massachusetts-based drugmaker. The findings reinforce the company's positioning of litifilimab as a potential first-in-class treatment in an area with limited therapeutic options.
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A notable finding involved participants who had been receiving placebo for the first 24 weeks of the trial. After switching to litifilimab, those patients began experiencing treatment effects in as little as four weeks, suggesting a rapid onset of action regardless of when therapy was initiated.
Biogen presented the results to the EADV 2026 Congress, one of dermatology's leading scientific forums, signaling continued development momentum for the asset. The AMETHYST study's Phase 3 component remains ongoing, and the 52-week Phase 2 data are expected to inform the broader regulatory pathway for the drug.
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