Biogen's Lupus Pipeline Takes Center Stage, Highlighting Shift in Company Focus

Biogen, a pharmaceutical giant known for its multiple sclerosis (MS) treatments, is making significant strides in the lupus space, leveraging its immunological expertise to address an area of high unmet need. The company recently held an investor call showcasing its lupus portfolio, which includes two late-stage assets representing a multi-faceted approach to this complex autoimmune disease.

Dapirolizumab Pegol and Litifilimab: Biogen's Late-Stage Lupus Contenders

Biogen's lupus pipeline is spearheaded by two promising candidates in Phase III trials. Dapirolizumab pegol (DZP), developed in collaboration with UCB, is currently undergoing a second Phase III study for systemic lupus erythematosus (SLE), with confirmatory data expected in late 2027 or 2028. This humanized Fc-free polyethylene glycol (PEG)-conjugated antigen-binding fragment targets CD40L, a key player in the immunological cascade of SLE.

Litifilimab, a humanized IgG1 monoclonal antibody targeting BDCA2, is being evaluated in three ongoing Phase III studies for both SLE and cutaneous lupus erythematosus (CLE). The first set of Phase III data for litifilimab in SLE is anticipated by the end of 2026, with CLE data following in 2027. Litifilimab's mechanism of action involves reducing the production of pro-inflammatory molecules by plasmacytoid dendritic cells, which are thought to play a significant role in both SLE and CLE.

Expanding Horizons: Biogen's Strategic Shift

Diana Gallagher, Senior Vice President of the Multiple Sclerosis and Immunology Disease Unit and Alzheimer's and Dementia Disease Unit at Biogen, emphasized the company's strategic evolution. "We're at this inflection point now," Gallagher stated, highlighting Biogen's decade-long work in lupus. The company aims to balance its portfolio across neurology, immunology, and rare diseases, with the lupus franchise potentially taking a more prominent role alongside its established MS portfolio.

This shift in focus has not gone unnoticed by industry analysts. BMO Capital Markets praised Biogen's "thoughtful approach" to developing assets targeting lupus, a disease with high unmet need. The analysts suggested that Biogen's pipeline may be underappreciated, given the recent emphasis on commercial stories like Leqembi, Skyclarys, and Spinraza.

Navigating the Challenges of Lupus Drug Development

The lupus landscape has been notoriously challenging, with only two drugs approved in the past 50 years: GSK's Belimumab in 2011 and AstraZeneca's Saphnelo in 2021. Gallagher cited sociodemographic factors, complex biology, and a history of failed trials as barriers to therapeutic progress in this field.

Despite these challenges, Biogen believes its experience in MS provides a strong foundation for tackling lupus. Both diseases share similarities in their immunological basis, predominantly affecting young women and following a relapsing/remitting course. Gallagher expressed confidence in Biogen's ability to "unravel" the complexities of lupus, much as they did with MS decades ago.

As Biogen continues to advance its lupus pipeline, the pharmaceutical industry watches closely. With multiple late-stage readouts expected in the coming years, Biogen's strategic pivot could potentially reshape the lupus treatment landscape and reinvigorate the company's position in the competitive pharmaceutical market.