Principia Announces Expanded Development Program to Broaden BTK Footprint in Immune-Mediated Diseases - Seite 2

Treatment is typically glucocorticoids (GCs), however, patients often relapse after GCs are tapered and thus require chronic GC dosing, which can lead to severe and debilitating side effects. Rituximab has been shown to have an effective clinical response; however, patients frequently relapse after treatment as well. Recent advances in the field have led to recognition of this disease and the many unmet needs for the patients diagnosed with it. Awareness and recognition of IgG4-RD is growing and the exact prevalence remains unknown, with estimates ranging from 40,000 to 180,000 in the United States alone. The company anticipates initiating a Phase 2 clinical trial in the first half of 2020.

Timely with the company’s clinical development program, the American College of Rheumatology and European League Against Rheumatism published new IgG4-RD diagnosis and treatment guidelines in the January 2020 issue of Arthritis and Rheumatology. These new treatment guidelines were led by Dr. Stone who commented: “Despite the seriousness of IgG4-RD, guidelines and treatment criteria have been non-existent. Validated in 1,879 subjects, these criteria should contribute substantially to future clinical, epidemiologic, and basic investigations.”  

About Rilzabrutinib 
Rilzabrutinib, Principia’s most advanced drug candidate, is an oral, first-in-class, reversible covalent, BTK inhibitor optimized for the treatment of immune-mediated diseases. Bruton tyrosine kinase (BTK) is involved in innate and adaptive immune responses and is a critical signaling molecule in immune-mediated diseases. Rilzabrutinib data demonstrates an ability to block inflammatory immune cells, eliminate autoantibody destructive signaling, and prevent new autoantibody production without depleting B cells. Rilzabrutinib’s unique attributes are based in the power of the bond from Principia’s proprietary Tailored Covalency platform.  This enabled the company to optimize rilzabrutinib’s safety and efficacy profile, with prolonged and reversible action at the target site while being rapidly eliminated from the body. Principia believes this bonding and the limited systemic exposure of rilzabrutinib enables rapid clinical reversibility of effects on the immune system, and it is thus designed for safety in immune-mediated diseases.