Enrollment in Phase 3 VALOR study evaluating brepocitinib in dermatomyositis is now complete, according to Priovant Therapeutics.
Data are anticipated in the second half of calendar year 2025, with a potential New Drug Application (NDA) submission to follow.
Brepocitinib is a dual selective inhibitor of oral tyrosine kinase 2 (TYK2) inhibitor and Janus kinase (JAK1) administered orally once daily. Through dual TYK2/JAK1 inhibition, brepocitinib suppresses signaling of multiple pathogenic cytokines that are understood to drive DM disease activity. The only approved therapies for DM are steroidal products and intravenous immunoglobulin (IVIg).
The VALOR study enrolled 241 subjects across 90 sites in four continents. VALOR is a double-blind placebo-controlled study with subjects randomized 1:1:1 to brepocitinib 30mg, brepocitinib 15mg, and placebo. The primary endpoint in the VALOR study is the Total Improvement Score (TIS) at 52 weeks. The TIS is a registrational composite endpoint of six measures of DM disease activity. Secondary endpoints include additional measurements of skin and muscle disease, measurements of disease activity in other impacted organ systems, steroid-sparing benefit, and patient-reported quality of life outcomes.
“Dermatomyositis is a highly morbid disease for which we have limited treatment options available,” says Dr. Ruth Ann Vleugels, MD, MPH, MBA., Heidi and Scott C. Schuster Distinguished Chair in Dermatology, Director of the Autoimmune Skin Disease Program and Connective Tissue Disease Clinics at Brigham and Women’s Hospital, and Program Director for the Rheumatology-Dermatology Fellowship at Harvard Medical School in Boston, MA, in a news release. “Brepocitinib is a promising investigational therapy with the potential to transform standard of care treatment for dermatomyositis if approved. The rapid enrollment of the VALOR study reflects the myositis medical community’s commitment to this crucial goal. We look forward to seeing the study’s results next year and to ideally having an excellent therapeutic option for our patients with this debilitating disease.”
Priovant also continues to advance brepocitinib’s development for treatment of non-infectious uveitis (NIU).
