Palatin Technologies, Inc. announced the initiation of a Phase 2b clinical trial with the melanocortin agonist, bremelanotide. The BREAKOUT Study, entitled ‘A Phase 2b, Multicenter, Open-Label, Prospective Study of BREmelanotide in DiAbetic Kidney Disease to Assess the Efficacy in Reducing Urinary PrOtein and Maintaining Podocyte Density and FUncTion' initiated patient screening/enrollment in December 2022, and currently expects to initiate patient dosing in January 2023. The BREAKOUT Study (BMT-701) is designed to enroll up to 45 subjects, with biopsy-proven type II diabetic kidney disease and >1000 mg/gm UP/Cr ratio.

Patients will administer bremelanotide therapy twice a day (BID), in addition to their maximum tolerated RAAS inhibition therapy, for six months, followed by a 12-month follow-up period. The primary endpoint of the study is a 50% reduction in their urine protein/creatinine (UP/Cr) ratio after six months of combined therapy (RAAS inhibition therapy plus bremelanotide). Secondary endpoints include analyses of partial remission, clinical remission and change in eGFR.

The open label BREAKOUT Study will enroll patients at up to seven U.S. sites. Completed patient data will be reviewed and assessed throughout the Study. Based on current enrollment estimates, the BREAKOUT Study is expected to complete enrollment in the third quarter of calendar year 2023, with final topline data by end of the first quarter of calendar year 2024.