Full Press Release Details
• CS is a highly morbid, chronic, and disfiguring condition with no approved therapies
• Brepocitinib is the first investigational therapy to generate a positive result in a placebo-controlled CS study (Phase 2 BEACON) and has received FDA Breakthrough Therapy Designation for CS
• Global Phase 3 study (BEACON+) is underway, evaluating brepocitinib 45 mg once daily against placebo in 140 patients across approximately 70 sites globally; BEACON+ topline data expected in calendar year 2028
• Brepocitinib’s development program now includes four indications with ongoing or successfully completed registrational trials: dermatomyositis (DM), non-infectious uveitis (NIU), lichen planopilaris (LPP), and CS; potential NDA approval and product launch in DM expected by the end of September 2026
DURHAM, N.C., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Priovant today announced that the first patients have been enrolled in the Phase 3 study evaluating brepocitinib in cutaneous sarcoidosis (CS). This follows brepocitinib’s Phase 2 study, the first positive placebo-controlled study in CS, which led to FDA Breakthrough Therapy Designation.
The Phase 3 study (BEACON+) will be conducted as a Part B to the positive Phase 2 BEACON trial. BEACON+ will enroll approximately 140 patients with cutaneous sarcoidosis across approximately 70 sites globally. Patients will be randomized 3:2 between brepocitinib 45mg once daily and placebo. The primary endpoint is the proportion of patients achieving a 50% or greater reduction in the Cutaneous Sarcoidosis Activity and Morphology Instrument – Activity Score (CSAMI-A) at Week 16. In Phase 2, 77% of brepocitinib 45mg patients achieved this endpoint compared to 0% of placebo patients. Topline data from the BEACON+ study is expected in calendar year 2028.
CS is an inflammatory granulomatous skin disease affecting approximately 40,000 adults in the United States. The condition disproportionately impacts Black Americans. Unlike many inflammatory skin diseases, inadequately treated cutaneous sarcoidosis can rapidly cause permanent scarring and destruction of bone, cartilage, and hair follicles. Despite this significant unmet therapeutic need, there are currently no FDA-approved therapies for CS.
“Our vision is to establish brepocitinib as a leading treatment option across multiple rare diseases with high patient burden and few or no alternative therapies,” said Ben Zimmer, Priovant CEO. “The potential upcoming approval and launch of brepocitinib in dermatomyositis later this quarter would be an important milestone toward that vision. We are equally committed to rapidly advancing brepocitinib’s development across multiple additional diseases where patients have a similar urgent need for new treatment options, and the initiation of our CS Phase 3 study reflects that commitment.”
With BEACON+ underway, brepocitinib’s orphan disease development program now includes four indications with ongoing or successfully completed registrational trials. In dermatomyositis (DM), brepocitinib’s NDA is currently under Priority Review with FDA with a PDUFA date later this quarter, following the positive Phase 3 VALOR readout. In non-infectious uveitis (NIU), the Phase 3 CLARITY trial is anticipated to read out later this year. In addition to the Phase 3 BEACON+ study, Priovant is also actively enrolling a Phase 2/3 study evaluating brepocitinib in lichen planopilaris (LPP). All are indications with very high disease burden, risk of permanent organ damage if left untreated, and few or no FDA-approved therapies.
About Priovant
Priovant Therapeutics is a biotechnology company dedicated to developing novel therapies for autoimmune diseases with high morbidity and few available treatment options. The company's lead asset is brepocitinib, a first-in-class, selective inhibitor of TYK2 and JAK1. Through dual TYK2/JAK1 inhibition, brepocitinib distinctively suppresses key cytokines linked to autoimmunity—including type I IFN, type II IFN, IL-6, IL-12 and IL-23—with a single, targeted, once-daily oral therapy. Brepocitinib recently generated positive Phase 3 data in dermatomyositis. The New Drug Application for brepocitinib in dermatomyositis is under review at FDA. Brepocitinib is also being evaluated in a Phase 3 program in non-infectious uveitis, a Phase 3 program in cutaneous sarcoidosis, and a Phase 2b/3 program in lichen planopilaris. Priovant Therapeutics is a Roivant (Nasdaq: ROIV) company.