Priovant Announces Positive Phase 2 Results for Brepocitinib in Cutaneous Sarcoidosis (CS)
Rhea-AI Summary
Priovant (Nasdaq: ROIV) announced positive Phase 2 BEACON results for brepocitinib in cutaneous sarcoidosis (CS), showing clinically meaningful and statistically significant benefit versus placebo at Week 16.
Key results: brepocitinib 45 mg achieved a -22.3 mean CSAMI-A change (∆21.6 vs placebo; P<0.0001), 100% ≥10-point CSAMI-A responses, 62% functional remission (CSAMI-A<5), and 69% IGA two-point improvements. No SAEs; AEs mild/moderate. Priovant plans Phase 3 initiation in 2026 following FDA engagement.
Positive
- CSAMI-A mean change -22.3 at Week 16 (45 mg)
- 100% of 45 mg patients achieved ≥10-point CSAMI-A improvement
- 69% achieved two-point IGA improvement to Clear/Almost Clear
- 62% functional remission (CSAMI-A <5) in 45 mg arm
- Statistically significant separation vs placebo as early as Week 4
- No serious adverse events; AEs mild or moderate
Negative
- Small trial size: 31 patients across three arms
- Some key endpoints for 15 mg vs placebo lacked statistical significance (functional remission P=0.1013)
- 45 mg arm comprised more treatment‑refractory patients, complicating cross-arm comparisons
- Brepocitinib 45 mg significantly improved cutaneous sarcoidosis disease activity, achieving a 22.3-point improvement in mean CSAMI-A at Week 16 versus a 0.7-point improvement in placebo (Δ 21.6 P<0.0001)
- All brepocitinib 45 mg patients achieved a clinically meaningful response, with
100% demonstrating at least a 10-point improvement on CSAMI-A - On the Investigator’s Global Assessment (IGA),
69% percent of brepocitinib 45 mg patients compared to0% of placebo patients achieved the gold standard two-point improvement to “Clear” (0) or “Almost Clear” (1) (Δ69% P=.0047) - Brepocitinib 15 mg patients also improved considerably, with numerically similar improvement to the 45 mg arm on lower-bar endpoints and evidence of dose-dependent benefit seen on higher bar endpoints and patient reported outcomes
- Brepocitinib was well tolerated during the study treatment period, with no Serious Adverse Events (SAEs) and all Adverse Events (AEs) graded mild or moderate in severity
- Priovant plans to progress CS to a pivotal program with a Phase 3 study starting in calendar year 2026 following engagement with the FDA, representing the third indication with a pivotal program for brepocitinib
DURHAM, N.C., Feb. 06, 2026 (GLOBE NEWSWIRE) -- Priovant Therapeutics today announced positive results from the Phase 2 BEACON study evaluating brepocitinib in cutaneous sarcoidosis (CS). CS is a highly morbid, chronic, and disfiguring condition with no approved therapies, and the BEACON study is the first ever industry-sponsored placebo-controlled trial in the indication to read out positively.
“The BEACON study is a watershed moment for the sarcoidosis field, and most importantly, for our patients,” said Dr. Misha Rosenbach, MD, Professor of Dermatology and Rheumatology and Director of the Cutaneous Sarcoidosis Program at the Hospital of the University of Pennsylvania. “This is an incredible milestone for a historically neglected disease – the study drug showed a clear difference in patients who received the medication compared to placebo, both from the patient and the physician perspective, and appeared to be well tolerated. This is the sort of data you dream of seeing when you look at trial results – and I would call this a transformational moment for sarcoidosis.”
The BEACON study enrolled 31 patients across 15 sites in the United States, randomized 3:2:2 to once daily brepocitinib 45 mg, 15 mg, or placebo with a 16-week treatment period. The brepocitinib 45 mg arm comprised the most treatment-refractory group, with the highest percentage of patients with longstanding disease, damage, and difficult-to-treat plaque-predominant morphology. Despite this, patients in the 45 mg arm achieved meaningful clinical improvement compared to placebo, including
On the Cutaneous Sarcoidosis Activity and Morphology Instrument – Activity score (CSAMI-A), brepocitinib 45 mg achieved a 22.3-point mean improvement at Week 16 versus a 0.7-point improvement in placebo (Δ21.6 P<0.0001). Statistically significant separation was observed as early as Week 4 and maintained at all timepoints thereafter. One hundred percent of brepocitinib 45 mg patients achieved at least a 10-point improvement on CSAMI-A compared to
| Treatment Arm | Mean CSAMI-A Change from Baseline at Week 16 | Achievement of CSAMI-A ≥ 10-point Reduction at Week 16 | Achievement of CSAMI-A < 5 (Functional Remission) at Week 16 | ||
| 45 mg (n = 13) | -22.3 | ||||
| 15 mg (n = 11) | -22.2 | ||||
| Placebo (n = 7) | -0.7 | ||||
| 45 mg vs. placebo | ∆ -21.6; P<0.0001 | ∆ | ∆ | ||
| 15 mg vs. placebo | ∆ -21.5; P<0.0001 | ∆ | ∆ | ||
On the Investigator’s Global Assessment (IGA),
Brepocitinib was well tolerated during the study treatment period, with no Serious Adverse Events (SAEs) and all Adverse Events (AEs) graded mild or moderate in severity. Brepocitinib has been evaluated in more than 1,500 patients and subjects, with an observed safety profile consistent with approved JAK1 and TYK2 inhibitors.
Priovant plans to initiate a Phase 3 program in CS in calendar year 2026, following engagement with FDA.
“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. “I would like to thank all of the patients, investigators, and site staff who participated in the study and made this result possible. 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.”
About Cutaneous Sarcoidosis
Cutaneous sarcoidosis (CS) is an inflammatory granulomatous skin disease affecting approximately 40,000 adults in the United States. CS lesions are frequently chronic, may involve extensive body surface area, and are often profoundly disfiguring, leading to substantial psychosocial distress and impaired quality-of-life. Despite this significant unmet therapeutic need, no treatments are currently approved for CS. As a result, many patients rely on prolonged off-label treatment with systemic corticosteroids, immunosuppressants, and biologics, which offer limited efficacy and carry meaningful treatment-related toxicity.
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 dual 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, and an NDA submission is planned for early 2026. Brepocitinib is also being evaluated in a Phase 3 program in non-infectious uveitis and recently generated positive Phase 2 data in cutaneous sarcoidosis, with a Phase 3 study to begin in calendar year 2026. Priovant Therapeutics is a Roivant (Nasdaq: ROIV) company.
Contact
Daniel Herz Roiphe, daniel.herz-roiphe@priovant.com
FAQ
What were the primary Phase 2 BEACON results for Priovant's ROIV brepocitinib in cutaneous sarcoidosis?
How did brepocitinib 45 mg perform on Investigator’s Global Assessment in the ROIV Phase 2 trial?
What safety findings did Priovant report for brepocitinib in the cutaneous sarcoidosis study (ROIV)?
Will Priovant (ROIV) advance brepocitinib to Phase 3 for cutaneous sarcoidosis and when?
How did the brepocitinib 15 mg arm compare to 45 mg and placebo in the BEACON trial (ROIV)?
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