Core Insights - The BREAKOUT study demonstrated that bremelanotide therapy resulted in significant improvements in patients with Type 2 diabetic nephropathy, with 71% achieving a greater than 30% reduction in urine protein to creatinine ratio and 71% showing improved or stabilized estimated glomerular filtration rate [1][3][4] Company Overview - Palatin Technologies, Inc. is focused on developing first-in-class medicines that modulate the melanocortin receptor system, targeting diseases with significant unmet medical needs [12] - The company has a pipeline that includes positive clinical results in diabetic nephropathy and other conditions, indicating a strong potential for future therapeutic options [4][12] Study Details - The BREAKOUT study enrolled 16 patients with confirmed Type 2 diabetic nephropathy, with 8 completing the six-month treatment regimen [2] - Patients received bremelanotide subcutaneously twice daily alongside their maximum tolerated dose of RAAS inhibition therapy [2] Efficacy Results - Bremelanotide therapy led to increased urinary VEGF levels in 37.5% of patients and reduced urinary synaptopodin losses in 36% of patients [1][3] - The study's findings support the potential of melanocortin receptor modulation as a new therapeutic strategy for diabetic nephropathy [4][6] Safety Profile - Bremelanotide was well tolerated, with no serious adverse events attributed to the treatment; the most common adverse event was skin hyperpigmentation, occurring in 71% of patients [4]
Palatin Announces Positive Phase IIb BREAKOUT Study Results in Patients with Type 2 Diabetic Nephropathy