BCD-256

Biogen trumpeted new Phase 2 lupus data on Saturday for a program it hopes will become a pillar of its immunology pipeline. The drug litifilimab improved patients’ skin lesions after 24 weeks, with 14.7% reaching a “clear” or “almost clear” skin score compared to 2.9% of those who took placebo achieving such clearance. The 11.8% difference was statistically significant with a p-value of <0.05, Biogen said. Biogen is banking on continued success from litifilimab as CEO Chris Viehbacher continues his turnaround of the company. As Biogen investors have grown restless with the company’s strategy, Viehbacher and other company executives have pointed toward lupus as a key disease focus — despite not pursuing a CAR-T for lupus like many others. Though CAR-T in lupus and other autoimmune diseases is promising, data remain limited and early. Regardless, several biotechs have seized on the excitement to pivot their CAR-T and CAR-NK programs toward lupus, particularly for patients with severe disease who don’t respond well to current treatments. Saturday’s data come from a trial testing litifilimab in a form of lupus called cutaneous lupus erythematosus, or CLE, which only affects the skin. Biogen is also developing litifilimab for systemic lupus erythematosus (SLE), the most common form of lupus affecting internal organs, according to the Lupus Foundation of America . Another lupus drug being being developed by Biogen, dapirolizumab pegol, has garnered more skepticism, given the lack of a CAR-T program. Viehbacher noted the logistics of CAR-T remain complicated and later-stage data have still yet to read out. Litifilimab is an anti-BDCA2 antibody designed to interfere with lupus patients’ overactive immune systems and tamp down inflammation. Two Phase 3 studies for litifilimab in SLE are expected to read out later this year, per the federal clinicaltrials.gov . A Phase 3 trial in CLE is still ongoing. Last year, Biogen agreed to a $250 million royalty deal with Royalty Pharma on litifilimab.