Priovant advances brepocitinib toward a third Phase 3 indication in cutaneous sarcoidosis
Durham-based Priovant Therapeutics has announced positive results from its Phase 2 BEACON study evaluating brepocitinib in cutaneous sarcoidosis (CS).
CS is an inflammatory granulomatous skin disease that affects about 40,000 adults in the United States. CS is a highly morbid, chronic and disfiguring condition with no approved therapies. With no treatments currently approved for CS, many patients rely on off-label treatment with systemic corticosteroids, immunosuppressants and biologics, which don’t always work well and can come with significant side effects. 
“We are thrilled with the results of the BEACON study and are excited to rapidly move brepocitinib into Phase 3 development for cutaneous sarcoidosis,” said Ben Zimmer, Priovant CEO.
The company plans to start a Phase 3 CS program later in 2026, following discussions with FDA. This would mark the third indication in which brepocitinib would enter a pivotal, late-stage development program.
“With the brepocitinib CS program now moving into Phase 3 alongside the dermatomyositis and non-infectious uveitis programs, Priovant continues to advance our goal of developing brepocitinib as a potentially transformational therapy for patients with highly morbid autoimmune diseases underserved by existing treatment options.”
BEACON study highlights
The BEACON study enrolled 31 patients across 15 sites in the United States. Patients were randomized 3:2:2 to receive brepocitinib 45 mg, 15 mg or placebo once daily during a 16-week treatment period.
Although the brepocitinib 45 mg arm of the study included the highest percentage of the most severely affected patients, patients in this group showed the most meaningful clinical improvement compared to placebo, including a 100% response rates on multiple endpoints.
Patients who received brepocitinib 15 mg also showed substantial improvement. For less stringent (lower bar) measures, their improvement was similar to the 45 mg group. For more demanding (higher bar) measures and patient-reported outcomes, the results suggested a dose-dependent effect. Placebo patients, however, experienced almost no improvement.
Skin scores improve with treatment
Over the 16-week treatment period, patients taking brepocitinib 45 mg showed a disease activity score that dropped by an average of just over 22 points, as measured using The Cutaneous Sarcoidosis Activity and Morphology Instrument Activity (CSAMI-A) score. This tool is used to measure skin inflammation severity in sarcoidosis using a score ranging from 0 to 165, with higher being worse.
For the patients receiving brepocitinib 45 mg, disease improvement was seen by week four of treatment and continued through the rest of the study. Everyone in this group experienced at least a 10-point improvement on in CSAMI-A score, compared to 14% of placebo patients, and 62% reached a level of disease activity considered to be functional remission.
The study also showed that brepocitinib was well tolerated during the treatment period, with no Serious Adverse Events (SAEs) and all Adverse Events (AEs) graded mild or moderate in severity.
Priovant Therapeutics was founded in 2021 through a partnership between Roivant Sciences and Pfizer. The company was created around brepocitinib, a drug previously in development at Pfizer and now Priovant’s lead molecule.
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