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 obser.