Biogen and UCB Promising Phase-III Trial Data for Lupus; CAR T-Cell Therapy Another Autoimmune Treatment Avenue

Biogen (BIIB.O) and UCB (UCB.BR) have reported promising results from a late-stage trial of their experimental lupus treatment, dapirolizumab pegol. This marks substantial progress in the field, especially following a surprising turnaround after a previous mid-stage failure. UCB and Biogen are leading biopharmaceutical companies advancing treatments for central nervous system (CNS) and immunological disorders. Furthermore, the exploration of CAR T-cell therapy presents an alternative potential targeted treatment for lupus and lupus nephritis, aiming to offer new hope for managing autoimmune diseases.

Advancements in Lupus Treatment: Progress and Market Implications of Dapirolizumab Pegol

Biogen and UCB’s lupus drug, dapirolizumab pegol, achieved its primary goal in a late-stage trial. The drug shows potential as a treatment for lupus, pending consistent results in another trial. Dapirolizumab pegol reduced disease activity when combined with corticosteroids and immune-suppressing drugs. The trial compared the drug to a placebo using a 3-2-1 patient trial design. This design effectively measured treatment effectiveness and safety.

Lupus mainly affects women and presents unpredictable symptoms, increasing the need for effective therapies. Drugs like AstraZeneca’s Saphnelo and GSK’s Benlysta have advanced treatments, but faster options are still needed. Dapirolizumab pegol’s success stands out due to the growing demand for better treatments.

Introducing dapirolizumab pegol could reshape the lupus treatment market. Current therapies like Saphnelo and Benlysta have shown strong sales, highlighting demand. Positive trial results suggest dapirolizumab pegol could capture a significant market share. Its introduction may drive competition and innovation in lupus treatments, benefiting patients.

Advancements in CNS Disorders and Immunology: UCB and Biogen

UCB SA and Biogen Inc. are biopharmaceutical companies focused on advancing therapies for serious diseases. UCB, based in Belgium, specializes in CNS and immunology disorders. It targets epilepsy, diabetic neuropathic pain, multiple sclerosis, fibromyalgia, restless legs syndrome, and Parkinson’s disease, while also addressing immunological conditions such as bone loss disorders, Crohn’s disease, rheumatoid arthritis, and respiratory diseases. Its product portfolio includes drugs like Neupro, Vimpat, and Cimzia, along with molecule solutions for severe disease treatments. 

Meanwhile, Biogen is dedicated to developing therapies for conditions such as multiple sclerosis (MS), spinal muscular atrophy (SMA), Alzheimer’s disease, and amyotrophic lateral sclerosis (ALS). It emphasizes pipeline advancements in neurology, specialized immunology, and rare diseases, with key products including TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI, and FAMPYRA for MS. Additionally, Biogen markets SPINRAZA for SMA, SKYCLARYS for Friedreich’s Ataxia, and QALSODY for ALS, and collaborates on drugs like LEQEMBI and RITUXAN. Both companies also provide biosimilars, with Biogen offering options like BENEPALI and IMRALDI.

Alternative Directions: UC Davis Health Explores CAR T-Cell Therapy for Lupus Treatment

Researchers at UC Davis Health are conducting a clinical trial to evaluate CAR T-cell therapy as a potential treatment for systemic lupus erythematosus (SLE) and lupus nephritis (LN). CAR T cells, commonly used for treating cancers such as leukemia and lymphoma, are genetically modified T cells designed to target and destroy B cells, which play a key role in autoimmune diseases like lupus. The trial uses CABA-201, an investigational therapy aimed at reducing disease activity by eliminating harmful B cells. In this process, participants undergo apheresis, which isolates their T cells, and these cells are then modified to include a chimeric antigen receptor (CAR) to specifically target B cells.

Moreover, the clinical trial aims to assess the safety and effectiveness of a single dose of CABA-201. If successful, the therapy could offer a more targeted treatment option, potentially reducing the need for long-term immunosuppressive medications. The study, funded by Cabaletta Bio, is one of nine worldwide and the only one in the Western United States. UC Davis Health plans to enroll 12 patients, six with active lupus nephritis and six with non-renal SLE, in the hope of providing a lasting solution to managing lupus.

Author

Bernice Lottering