Palatin reports positive Phase 2b results in diabetic nephropathy

Palatin (PTN) announced topline data for the BREAKOUT study, a Phase IIb study of bremelanotide in diabetic kidney disease. The study showed that bremelanotide therapy for six months, in patients with established Type II diabetic nephropathy, resulted in positive and beneficial results for the majority of patients related to worsening kidney function and disease progression. Clinically meaningful endpoints included: 71% of patients achieved a greater than 30% reduction in the urine protein to creatinine ratio, 71% of patients achieved improved or stabilized estimated glomerular filtration rate, increased urinary vascular endothelial growth factor levels in 37.5% of patients and reduced urinary synaptopodin losses in 36% of patients. Bremelanotide was well tolerated. There were no serious adverse events attributable to bremelanotide treatment. The most common adverse event was skin hyperpigmentation, which occurred in 71% of patients. Diabetic nephropathy is the most common form of chronic kidney disease and a leading cause of renal failure in end-stage renal disease. No currently available treatment can achieve complete cure. As many as 47.66% of patients with diabetes have been estimated to have DN.