First patients enrolled in phase 3 CLARITY trial evaluating brepocitinib in non-anterior non-infectious uveitis

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Proviant Therapeutics announced the first patients have been enrolled in CLARITY, its phase 3 study (NCT06431373) evaluating brepocitinib in non-anterior non-infectious uveitis and that the US Food and Drug Administration (FDA) granted Fast Track Designation to brepocitinib for non-infectious uveitis.

Brepocitinib is a potential first-in-class dual selective inhibitor of TYK2 and JAK1 under evaluation for multiple highly morbid orphan autoimmune diseases, administered as an oral therapy once daily.¹

The CLARITY trial will be a global multi-center Phase 3 program comparing brepocitinib 45 mg to placebo in patients with non-anterior non-infectious uveitis. The trial will consist of 2 sub-studies under a single protocol with 150 subjects in each sub-study (300 subjects total) randomized 1:1 to brepocitinib 45 mg and placebo, with a primary endpoint of time to treatment failure.¹ The study is closely modeled after the phase 2 NEPTUNE study (NCT05523765).

The phase 2 NEPTUNE study evaluated brepocitinib in non-anterior non-infectious uveitis and a dose-dependent treatment benefit was observed on multiple endpoints of clinical significance.

On the primary efficacy endpoint of treatment failure at 6 months, brepocitinib 45 mg showed the numerically greatest efficacy benefit observed to date of any therapy evaluated for non-infectious uveitis. Furthermore, as measured through the Angiography Scoring for Uveitis Working Group (ASUWOG) grading system on wide field fluorescein angiography, brepocitinib 45 mg demonstrated a mean 4.4-point decrease in retinal vascular leakage while the 15 mg arm demonstrated a mean 0.5-point decrease.

Top-line 52-week phase 2 data from NEPTUNE is projected to be available by the end of the year.

Quan Dong Nguyen, MD, MSc, FAAO, FARVO, FASRS, CLARITY investigator and Professor of Ophthalmology at the Byers Eye Institute, and Professor of Medicine and Pediatrics at Stanford University School of Medicine commented on the CLARITY trial in the release from the company.

"Non-infectious uveitis is a devastating disease that, if inadequately managed, often leads to irreversible visual impairment or blindness. Current treatment options fail to meet many patients' needs, and brepocitinib's striking Phase 2 results from the NEPTUNE Study suggest that it has the potential to serve as a transformative therapy in controlling inflammation and improving visual acuity,” said Nguyen.

References:

1. Priovant Therapeutics Announces Receipt of Fast Track Designation from FDA for Brepocitinib in Non-Anterior Non-Infectious Uveitis (NIU) & Start of Enrollment of Brepocitinib Phase 3 NIU Program. Press Release; September 23, 2024. Accessed September 25, 2024. https://www.prnewswire.com/news-releases/priovant-therapeutics-announces-receipt-of-fast-track-designation-from-fda-for-brepocitinib-in-non-anterior-non-infectious-uveitis-niu--start-of-enrollment-of-brepocitinib-phase-3-niu-program-302254625.html?tc=eml_cleartime