#United States #Palatin Technologies #Cranbury #Bremelanotide #Diabetic Nephropathy

Positive Outcomes from the Phase IIb BREAKOUT Study by Palatin Technologies

Palatin Technologies, Inc., a biopharmaceutical firm listed on the NYSE American (PTN), has recently shared encouraging results from its Phase IIb BREAKOUT study, assessing the effectiveness of bremelanotide in patients suffering from Type 2 diabetic nephropathy (DN). This open-label clinical study focused on evaluating the drug's safety, tolerability, and efficacy in alleviating the complications associated with DN, which is a significant microvascular complication arising from diabetes.

Study Overview

The BREAKOUT study, officially named BMT-701, comprised 16 participants diagnosed with Type 2 diabetes and confirmed diabetic nephropathy. The patients had a urine protein to creatinine ratio exceeding 1000 mg/gm and were monitored for over six months. Closer to the end of the study, data revealed that 71% of these patients demonstrated at least a 30% reduction in their urine protein to creatinine ratio, indicating a substantial improvement in their kidney function.

Moreover, nearly three-quarters of the participants achieved improved or stabilized estimated glomerular filtration rates (eGFR). Remarkably, 37.5% of patients experienced an increase in urinary vascular endothelial growth factor (VEGF) levels, and 36% exhibited reduced urinary synaptopodin losses, which are crucial indicators of kidney health.

Significance of Findings

This data is significant, as it provides a glimpse into the potential of melanocortin receptor modulation as a novel therapeutic strategy for diabetic nephropathy. Carl Spana, Ph.D., President and CEO of Palatin Technologies, expressed optimism about these findings, suggesting that the data supports the idea of modulating the melanocortin system as a promising avenue for developing treatments targeting this progressive kidney disease.

The positive response from participants also reinforces previous studies that align the activation of melanocortin receptors with the improvement of kidney function. James A. Tumlin, MD, CEO of NephroNet Clinical Trials Consortium, stated that these findings align with existing literature regarding the beneficial effects of melanocortin receptor activation on podocyte function and overall kidney health.

Safe and Well-Tolerated Treatment

Clinical assessments did not reveal any serious adverse reactions attributable to bremelanotide. The most frequently reported side effect was skin hyperpigmentation, noted in 71% of the patients involved in the study.

Broader Implications

Diabetic nephropathy, being the leading cause of end-stage renal disease, poses a critical health challenge, affecting nearly 9% of the global adult population. The projected worldwide prevalence of diabetes rises steadily, with estimates suggesting approximately 592 million individuals will be living with the condition by 2035. The increasing incidence of diabetic nephropathy further complicates the healthcare landscape, necessitating urgent advancements in treatment modalities.

Given these statistics and the relative lack of effective treatments, Palatin Technologies' focus on developing targeted therapies like bremelanotide could represent a turning point in managing diabetic nephropathy, addressing a significant unmet medical need.

Future Developments

Palatin Technologies is committed to further investigating the use of bremelanotide in other conditions, such as their ongoing Phase 2 trial for ulcerative colitis. The topline data from this trial is expected to be released in the first quarter of 2025, potentially expanding the therapeutic scope of melanocortin receptor agonists.

As a frontrunner in the development of first-in-class treatments that modulate the melanocortin receptor system, Palatin remains steady in its mission to discover and deploy effective solutions for chronic diseases that currently lack satisfactory treatment alternatives.