Priovant Announces Successful Phase III Results for Brepocitinib in Dermatomyositis (VALOR Study)

Priovant Therapeutics and Roivant announced positive Phase 3 VALOR study results for brepocitinib, showing a significant improvement in dermatomyositis (DM) patients.

Brepocitinib achieved a mean 52-week Total Improvement Score (TIS) of 46.5 compared to 31.2 for placebo (p=0.0006), demonstrating clear statistical superiority.13

Over two-thirds (67%) of brepocitinib-treated patients experienced a moderate response (TIS≥40), and nearly half reached a major response (TIS≥60).1

62% of brepocitinib patients reduced steroid doses to ≤2.5 mg/day, compared to 34% for placebo, showing a strong steroid-sparing benefit.1

44% of patients with moderate-to-severe skin disease achieved cutaneous clinical remission at week 52, versus 21% on placebo.1

The safety profile of brepocitinib was consistent with previous studies, with no unexpected safety signals.1

An NDA filing for brepocitinib in dermatomyositis is planned for the first half of 2026.1

The VALOR study enrolled 241 patients across 90 sites on four continents, making it the first successful 52-week placebo-controlled and registrational trial for a targeted therapy in DM.23

Sources:

1. https://www.stocktitan.net/news/ROIV/roivant-and-priovant-announce-positive-phase-3-valor-study-results-6nn7zkhkonp3.html

2. https://thedermdigest.com/enrollment-complete-in-phase-3-study-of-brepocitinib-in-dm/

3. https://drug-dev.com/roivant-priovant-announce-positive-phase-3-study-results-for-brepocitinib-in-52-week-placebo-controlled-trial-in-dermatomyositis/