US-based biotechnology company Priovant Therapeutics has finished enrolling subjects in a Phase III trial of brepocitinib, a new drug candidate designed to treat dermatomyositis.
The double-blind, placebo-controlled VALOR trial enrolled 241 subjects across 90 sites over four continents. It is claimed to be the largest interventional study ever conducted for dermatomyositis.
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Trial participants were randomised at a 1:1:1 ratio to receive either 30mg or 15mg of brepocitinib or a placebo.
The study’s primary endpoint is the Total Improvement Score (TIS) at 52 weeks, a composite endpoint that includes six measures of dermatomyositis disease activity.
Its secondary endpoints include additional assessments of skin and muscle disease, evaluations of disease activity in other affected organ systems, the potential for steroid-sparing benefits, and the impact on patient-reported quality-of-life outcomes.
Results from the study are expected in the second half of next year, with the possibility of a new drug application submission to the US Food and Drug Administration (FDA) thereafter.
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By GlobalDataPriovant Therapeutics CEO Ben Zimmer said: “Priovant continues to make progress towards our goal of developing brepocitinib as a transformational therapy for highly morbid autoimmune diseases where the need for novel efficacious therapies is greatest.
“We look forward to providing further updates as we reach upcoming milestones in 2024 and 2025.”
Brepocitinib is a once-daily oral medication that functions as a dual selective inhibitor of TYK2 and JAK1.
This dual inhibition is key in suppressing the signalling of various cytokines believed to drive the activity of dermatomyositis.
More than 1,400 subjects have so far been dosed with brepocitinib and the drug has shown promising results in seven Phase II studies across a range of autoimmune conditions.
In addition to the VALOR study, Priovant is progressing with the development of brepocitinib for the treatment of non-infectious uveitis (NIU).
