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

• First patients have been dosed in CLARITY, a Phase 3 study evaluating brepocitinib in non-anterior non-infectious uveitis (NIU).
• Brepocitinib has also been granted Fast Track Designation from FDA for NIU.
• Study initiation follows successful Phase 2 study of brepocitinib in NIU (NEPTUNE) and productive End of Phase 2 Meeting with FDA.
• NEPTUNE 24-week wide field fluorescein angiography results were presented for first time at the EURETINA conference in Barcelona on September 20; clinically meaningful and dose-dependent improvement on retinal vascular leakage was observed from baseline to week 24, consistent with primary and secondary efficacy endpoints previously shared in the top-line readout.

DURHAM, N.C., Sept. 23, 2024 /PRNewswire/ -- Priovant Therapeutics today announced that the first patients have been enrolled in CLARITY, a Phase 3 study evaluating brepocitinib in non-anterior non-infectious uveitis. Brepocitinib has also been granted Fast Track Designation for NIU by FDA. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

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

In a prior Phase 2 study evaluating brepocitinib in non-anterior NIU (NEPTUNE), a dose-dependent treatment benefit was observed on multiple endpoints of clinical significance. On the primary efficacy endpoint of Treatment Failure at six months, brepocitinib 45 mg showed the numerically greatest efficacy benefit observed to date of any therapy evaluated for NIU. Patient-level wide field fluorescein angiography (FA) results on retinal vascular leakage at six months were presented for the first time on September 20 at the EURETINA Congress in Barcelona, Spain. As measured through the Angiography Scoring for Uveitis Working Group (ASUWOG) grading system on wide field FA, 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.

"FA is the gold standard measurement of posterior segment inflammation in uveitis," said Dilraj Grewal, MD, FASRS, Associate Professor of Ophthalmology, Vitreoretinal Surgery and Uveitis at Duke University and Associate Director of the Duke Reading Center, a comprehensive image reading center that specializes in systematic analysis of ophthalmic images captured in multicenter clinical trials. "The patient-level wide field FA results from the NEPTUNE trial show a clinically meaningful dose-dependent improvement on posterior segment inflammation from treatment with brepocitinib. With these results, the very strong clinical outcomes previously shared are now further supported by dose-dependent improvement on an important biomarker."

CLARITY is a global multi-center Phase 3 program comparing brepocitinib 45 mg to placebo in patients with non-anterior NIU. CLARITY will consist of two 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. The study is closely modeled on the successful NEPTUNE Phase 2 study and will enroll subjects at sites in the United States, Europe, Asia, Australia, and South America. The initiation of CLARITY follows a productive End of Phase 2 Meeting with FDA.

"The initiation of the CLARITY Study is an important milestone for the uveitis medical and patient communities," said 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. "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."

Patient-level macular edema results at week 24 from the NEPTUNE Study will be presented at the American Academy of Ophthalmology (AAO) annual meeting October 18-21 in Chicago. Top-line 52-week Phase 2 data from NEPTUNE will also be available by the end of the year.

In addition to NIU, brepocitinib is being evaluated in a fully enrolled Phase 3 study in dermatomyositis (VALOR). Top-line data from the VALOR Study is expected in the second half of 2025, with an NDA submission to follow if successful.

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 is able to distinctively suppress key cytokines linked to autoimmunity—including type I IFN, type II IFN, IL-6, IL-12, and IL-23—with a single, targeted therapy. Brepocitinib is administered as a once-daily oral therapy. It has been dosed in over 1,400 subjects and has generated positive data in seven Phase 2 studies. Brepocitinib is currently being evaluated in Phase 3 programs for dermatomyositis and non-infectious uveitis.

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Contact:
Daniel Herz-Roiphe
Priovant Therapeutics
[email protected] 

SOURCE Priovant Therapeutics