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Jump to Key Points Oct 2 (Reuters) - Biogen said on Friday its experimental drug showed durable improvement in skin symptoms among patients with a type of autoimmune disease in a mid-stage study.
Here are some details:
• Cutaneous lupus erythematosus (CLE) can cause painful rashes, sensitivity to sunlight, hair loss, skin discoloration and permanent scarring. There are no approved targeted treatments for the condition.
• The company said 27.2% of participants who received the drug, litifilimab, from the beginning of the trial had clear or almost clear skin after one year, compared with 19% after 24 weeks.
- CLE: no approved targeted therapies; antimalarial-refractory skin disease unmet need.
- Litifilimab: 27.2% clear/almost clear skin at 1 year; 19% at 24 weeks.
- ≥70% skin activity reduction: 29% at week 52 vs 21.7% at week 24.
- Trial n=93 adults; generally well tolerated, no new safety signals.
- Common AEs: URI-like infections, influenza, arthralgia; late-stage data due 1H 2027.
• Litifilimab is also being tested for lupus and other forms of the autoimmune condition.
• The trial results come as Biogen faces mounting pressure on its legacy multiple sclerosis portfolio from pricing challenges and competition, prompting it to rely on newer products, including Alzheimer's drug Leqembi, to revive growth.
• Nearly 29% of patients achieved at least a 70% reduction in skin disease activity at week 52, up from 21.7% at week 24, Biogen said.
• Litifilimab was generally well tolerated with no new safety concerns identified, it said.
• The mid-stage trial enrolled 93 adults whose skin symptoms had not responded to, or who could not tolerate, standard antimalarial medicines.
• The most common side effects included common cold-like infections, influenza and joint pain.
• Biogen said litifilimab aims to suppress inflammation by targeting BDCA2 receptors found on plasmacytoid dendritic cells, which are immune cells that trigger and regulate the body's defense mechanisms.
• Biogen expects results from the late-stage part of the study in the first half of 2027.
(Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Shilpi Majumdar)
