Ben Zimmer, CEO of Priovant Therapeutics, discusses the VALOR clinical trial testing investigational therapy for dermatomyositis treatment, brepocitinib.
Dermatomyositis is a rare autoimmune condition that causes skin changes and muscle weakness. Symptoms can include a red skin rash around the eyelids, red bumps around the joints, and muscle weakness in the arms and legs. Muscle weakness gets worse over time and can lead to stiff joints and muscle wasting. Current approved treatment options include steroid medications and intravenous immunoglobulin.
Brepocitinib is a dual selective inhibitor of TYK2 and JAK1 administered orally once daily. The medication targets and suppresses the signaling of pathogenic cytokines known to cause disease activity in dermatomyositis.
The phase 3 VALOR clinical trial is a double-blind, placebo-controlled, randomized study testing the safety and efficacy of brepocitinib for the treatment of dermatomyositis. The primary endpoint of the trial is the Total Improvement Score (TIS) at 52 weeks. The TIS composed of six measures of disease activity. Secondary endpoints include measurements of skin and muscle disease and other organ involvement, steroid-sparing benefit, and patient-reported quality of life outcomes.
Data from this study is expected in the second half of 2025. A potential New Drug Application (NDA) submission is expected to follow.
To learn more about rare autoimmune conditions, visit https://checkrare.com/diseases/autoimmune-auto-inflammatory-disorders/
