Roivant Spinout Priovant Advances Brepocitinib to Phase 3 with Landmark Phase 2 Data in Cutaneous Sarcoidosis

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Priovant Therapeutics, a Roivant spinout, announced positive Phase 2 BEACON study results for brepocitinib in cutaneous sarcoidosis, showing a mean 22.3-point improvement on the CSAMI-A scale (vs. 0.7 for placebo) in 31 patients at the high dose.13

The results, described as landmark by lead investigator Misha Rosenbach, exceeded expectations and were statistically significant from week 4, with 100% of high-dose patients achieving at least a 10-point improvement.13

Priovant plans to initiate a Phase 3 trial for brepocitinib in cutaneous sarcoidosis this year, pending FDA discussions.13

Brepocitinib, a dual JAK1/TYK2 inhibitor, previously succeeded in the Phase 3 VALOR study for dermatomyositis (DM) in September 2025, with NDA submission planned for H1 2026.23

Cutaneous sarcoidosis is a rare, neglected immune skin disease; this is the first industry-sponsored placebo-controlled trial with positive data.3

Sources:

1. https://www.statnews.com/2026/02/06/roivant-immune-drug-significantly-outperformed-placebo-in-treating-rare-skin-disease/

2. https://finviz.com/news/168192/roivant-and-priovant-announce-positive-phase-3-valor-study-results-for-brepocitinib-in-52-week-placebo-controlled-trial-in-dermatomyositis-dm

3. https://www.biospace.com/drug-development/priovant-plots-path-to-phase-3-as-brepocitinib-clears-mid-stage-skin-disease-study