US-based biotechnology company Priovant Therapeutics announced on Monday, that it has completed enrolment of subjects for its phase three VALOR study assessing brepocitinib to treat dermatomyositis, a skin condition.

There are 241 participants in the study across 90 sites on four continents, making it the largest interventional dermatomyositis trial ever carried out.

Brepocitinib, a dual selective inhibitor of TYK2 and JAK1, is administered orally once daily. It suppresses signalling of multiple pathogenic cytokines that are understood to drive DM disease activity through dual TYK2/JAK1 inhibition. It has been dosed in more than 1,400 subjects and generated positive outcome in seven phase two studies across multiple autoimmune diseases.

The study's primary endpoint is the Total Improvement Score (TIS) at 52 weeks, while the 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. Data are expected to be revealed in the second half of 2025, with a potential NDA submission to follow.