Palatin begins enrollment in Phase 2 study of diabetic kidney disease candidate

Palatin announced the initiation of a Phase 2b clinical trial with the melanocortin agonist, bremelanotide. The BREAKOUT Study initiated patient screening/enrollment in December 2022, and currently expects to initiate patient dosing in January 2023. The study is designed to enroll up to 45 subjects, with biopsy-proven type II diabetic kidney disease and greater than1000 mg/gm UP/Cr ratio. The primary endpoint of the study is a 50% reduction in their urine protein/creatinine ratio after six months of combined therapy. Secondary endpoints include analyses of partial remission, clinical remission and change in eGFR. Based on current enrollment estimates, the BREAKOUT Study is expected to complete enrollment in 3Q23, with final topline data by end of 1Q24.