BIIB · News & developments
Biogen’s lupus candidate posts further skin-response gains at 52 weeks
Biogen reported 52-week results from the Phase 2 portion of the ongoing AMETHYST study of investigational litifilimab in cutaneous lupus. Among 93 adults, 27.2% of participants treated with litifilimab from the study’s start had clear or almost clear skin at Week 52, up from 19.0% at Week 24. A 70% or greater reduction in CLASI-A was reached by 28.8% at Week 52, compared with 21.7% at Week 24. Biogen said the Phase 3 portion remains blinded and results are expected in the first half of 2027. Litifilimab is investigational and has not been approved.
Why this matters
The longer follow-up strengthens the case that responses can build over time, but the percentages describe outcomes on two measures in a small Phase 2 group, not a controlled estimate of commercial uptake or a guarantee the effect will hold in Phase 3. That distinction matters economically: without approval, litifilimab contributes no product revenue, so the immediate value is a stronger rationale to keep funding development. The blinded Phase 3 readout is the point at which Biogen can test whether this early evidence survives a larger, later-stage trial.
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