Palatin Technologies, Inc. (NYSE American: PTN), a US-based biopharmaceutical company, announced on Thursday that it has begun a Phase 2b clinical trial with the melanocortin agonist, bremelanotide.

The BREAKOUT Study is titled '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'. It commenced patient screening/enrolment in December 2022. The company is likely to start dosing of patients this month.

The study is to enrol up to 45 subjects, with biopsy-proven type II diabetic kidney disease and >1000 mg/gm UP/Cr ratio. Subjects are to be administered with bremelanotide therapy twice a day (BID), in addition to their maximum tolerated RAAS inhibition therapy, for six months, subsequent to a 12-month follow-up period. The study's primary endpoint is a 50% reduction in the subject's urine protein/creatinine (UP/Cr) ratio after six months of combined therapy (RAAS inhibition therapy plus bremelanotide). The study's secondary endpoints include evaluation of partial remission, clinical remission and change in eGFR.