According to Priovant, the Phase 2 BEACON study is the first industry-sponsored placebo-controlled trial in cutaneous sarcoidosis to deliver positive data.
Priovant—a Roivant spinoff—is highlighting positive mid-stage data for its investigational JAK1/TYK2 dual inhibitor brepocitinib, which improved disease activity and elicited a meaningful treatment response in patients with cutaneous sarcoidosis.
In the Phase 2b BEACON study, Priovant enrolled 31 patients who were given 45 mg or 15 mg doses of brepocitinib or placebo. Intervention ran for 16 weeks, after which participants were evaluated for disease activity, as measured by the Cutaneous Sarcoidosis Activity and Morphology Instrument Activity (CSAMI-A) tool.
Patients on the higher brepocitinib dose saw a mean improvement of 22.3 points on the CSAMI-A, compared to placebo scores, which dropped by 0.7 points on average, according to data released Friday. The treatment effect—a 21.6-point advantage in favor of brepocitinib—was statistically significant.
“This is an incredible milestone for a historically neglected disease,” Misha Rosenbach, professor of dermatology and rheumatology and director of the Cutaneous Sarcoidosis Program at the Hospital of the University of Pennsylvania, said in Priovant’s statement.
Brepocitinib’s benefits started being significantly superior to placebo as early as week four, Priovant said in its Friday release, and were maintained thereafter. In addition, 100% of patients treated with the drug’s 45-mg dose saw at least a 10-point improvement in CSAMI-A scores, as compared with 14% in placebo comparators.
Affecting around 40,000 adults in the U.S., cutaneous sarcoidosis is an inflammatory skin disease that manifests as chronic lesions across the body. The condition is “often profoundly disfiguring,” Priovant said in its press release, in turn causing patients psychosocial distress and compromising their quality of life. The biotech also claimed in its announcement that BEACON is the “first ever industry-sponsored placebo-controlled trial in the indication to read out positively.”
CEO Ben Zimmer in a statement said the biotech is “thrilled” with Friday’s data, which will now serve as a springboard “to rapidly move brepocitinib into Phase 3 development for cutaneous sarcoidosis.” The late-stage program is set to begin this year, pending discussions with the FDA.
Taken orally once a day, brepocitinib is a small-molecule drug that works by blocking both the TYK2 and JAK1 pathways, which are key immune and inflammatory cascades. This mechanism of action gives brepocitinib its therapeutic potential for several autoimmune diseases, according to Priovant’s website.
The biotech is also advancing brepocitinib for dermatomyositis, an idiopathic inflammatory disease. Phase 3 data in September 2025 showed the drug resulted in significantly better treatment response than placebo—findings that Priovant said at the time supported a drug application in this indication. A filing is expected in the first half of this year.
In backing the formation of the company in partnership with Roivant in 2021, Pfizer licensed brepocitinib to Priovant. Pfizer owns a 25% stake in Priovant.
