Priovant Therapeutics’ cutaneous sarcoidosis (CS) drug has shown response rates of up to 100% on endpoints in a Phase II trial.
In the BEACON study (NCT06978725), which enrolled 31 patients randomised to receive 45mg or 15mg brepocitinib or placebo, patients who received the high-dose study drug achieved meaningful clinical improvement compared to placebo.
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Brepocitinib 15mg patients also improved considerably, with numerically similar response to the 45mg cohort; however, this was on lower-bar endpoints. There was also evidence of dose-dependent benefit seen on higher bar endpoints and patient-reported outcomes. Placebo patients experienced almost no improvement, consistent with the natural disease course.
On the CS Activity and Morphology Instrument – Activity score (CSAMI-A), high-dose brepocitinib achieved a 22.3-point mean improvement, compared to a 0.7-point improvement in placebo. The CSAMI-A is a scale from 0 to 165, designed to measure the severity of skin lesions in sarcoidosis.
All 45mg patients achieved at least a 10-point improvement on CSAMI-A compared to 14% of placebo patients, and 62% of brepocitinib high-dose patients achieved CSAMI-A <5, classified as functional remission, compared to 0% of placebo patients.
On the Investigator’s Global Assessment (IGA), 69% of brepocitinib 45mg dose patients achieved the gold standard two-point improvement to Clear (0) / Almost Clear (1), compared to 0% of placebo patients.
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By GlobalDataStatistically significant improvement over placebo was also observed on key patient-reported outcomes, including the King’s Sarcoidosis Questionnaire (KSQ) Skin Domain, the Skindex-16, and the Patient’s Global Impression of Change (PGI-C). On PGI-C, 100% of patients in the 45mg cohort reported improvement from baseline, compared to 29% in the placebo group.
Dr Misha Rosenbach, Professor of dermatology and rheumatology and director of the Cutaneous Sarcoidosis Program at the Hospital of the University of Pennsylvania, said: “The BEACON study is a watershed moment for the sarcoidosis field, and most importantly, for our patients. 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 drug was well tolerated during the study treatment period, with no serious adverse events (SAEs).
Based on the Phase II data, Priovant plans to initiate a Phase III programme of the TYK2/JAK1 inhibitor in CS in 2026, following engagement with the US Food and Drug Administration (FDA). CS is a highly morbid, chronic, and disfiguring condition with no approved therapies. It occurs in between 20% and 35% of systemic sarcoidosis patients, presenting with diverse, often red-brown or purple, skin lesions such as papules, nodules, plaques, or lupus pernio.
Priovant was established in 2021 and unveiled in 2022 through an alliance between Pfizer and Roivant Sciences to advance brepocitinib and selective TYK2 inhibitor ropsacitinib. Pfizer currently holds a 25% equity ownership stake in Priovant.
