By Fineline Cube 
French pharmaceutical giant Sanofi (NASDAQ: SNY) announced positive results from a Phase II study of rilzabrutinib for the treatment of IgG4-related disease (IgG4-RD). The study demonstrated significant reductions in disease relapse frequency and key biomarker levels, along with decreased reliance on glucocorticoids.
Clinical Trial Results
At the 52-week mark, 70% of patients treated with rilzabrutinib remained relapse-free without requiring additional therapy, such as glucocorticoids or immunosuppressants. Their IgG4-RD Responder Index (RI) scores showed substantial improvement. The safety profile of rilzabrutinib was consistent with previous studies.
Disease Background
IgG4-RD is a rare, progressive, chronic immune-mediated disease that can affect multiple organs, leading to tissue damage and potentially life-threatening complications. Rilzabrutinib, a novel oral BTK inhibitor, works by restoring immune balance through multiple immunomodulatory mechanisms.
Regulatory Designations
Rilzabrutinib has been granted Orphan Drug Designation (ODD) and Fast Track Designation (FTD) by the U.S. FDA for the treatment of IgG4-RD.-Fineline Info & Tech