Six-month open-label study showed clinically meaningful improvements in kidney function and disease in patients with Type 2 diabetic nephropathy.
71% achieved a >30% reduction in UP/Cr, a key indicator of kidney damage.
71% demonstrated improved or stabilized eGFR, signaling preserved kidney function.
37.5% had increased urinary VEGF levels, suggesting better blood vessel support in the kidneys.
36% had reduced urinary synaptopodin losses, indicating healthier kidney cells and structure.
CRANBURY, N.J., April 10, 2025 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, today announced that data from the Phase 2b BREAKOUT study will be presented today at the National Kidney Foundation Spring Meeting in Boston, MA. The poster presentation titled Efficacy of Bremelanotide (BMT) to Stabilize Podocyte Function and Reduce Proteinuria in Adults with Diabetic Type II Nephropathy: Results from a Phase IIb, Open-Label Study, will be presented by James A. Tumlin, M.D., CEO and Founder of NephroNet Clinical Trials Consortium, and the lead investigator for the study.
Palatin Technologies, Inc.
"The positive results from our Phase 2b study evaluating a melanocortin agonist in patients with diabetic Type 2 nephropathy represents our third major clinical milestone across distinct therapeutic areas," said Carl Spana, Ph.D., President and CEO of Palatin. "These results, along with previously announced positive topline data from our Phase 2 obesity and ulcerative colitis studies, and the advancement of our Phase 3 dry eye disease program, demonstrate the breadth and robustness of our melanocortin platform. Collectively, these data validate our scientific approach and further support the potential of melanocortin agonists as differentiated therapeutics in addressing significant unmet needs across metabolic, ocular, and inflammatory diseases."
The BREAKOUT Study (BMT-701) enrolled 16 patients with confirmed Type 2 diabetic nephropathy and >1000 mg/gm UP/Cr ratio, with 8 patients completing the six-month treatment regimen, at multiple sites in the United States. Patients were administered bremelanotide subcutaneously twice daily in addition to their maximum tolerated dose of renin-angiotensin-aldosterone system (RAAS) inhibition therapy and monitored through a follow-up period.
The data presented highlighted meaningful clinical improvements in patients with Type 2 diabetic nephropathy following six months of treatment with a low-dose of a melanocortin agonist. The therapy showed potential to slow disease progression and preserve kidney function. Key findings included:
71% of patients achieved a >30% reduction in the urine protein to creatinine ratio (UP/Cr), a key indicator of kidney damage.
71% of patients demonstrated improved or stabilized estimated glomerular filtration rate (eGFR), signaling preserved kidney function.
37.5% of patients had increased urinary vascular endothelial growth factor (VEGF) levels, suggesting better blood vessel support in the kidneys.
36% of patients had reduced urinary synaptopodin loss, indicating healthier kidney cells and structure.
Poster G-423f will be presented today, Thursday, April 10th at 5:00 PM EST at the National Kidney Foundation Spring Meeting and will be available as an e-poster on Palatin's website (www.Palatin.com).
About Melanocortin Receptor Agonists The melanocortin receptor ("MCR") system has effects on inflammation, immune system responses, metabolism, food intake, and sexual function. There are five melanocortin receptors, MC1R through MC5R. Modulation of these receptors, through use of receptor-specific agonists, which activate receptor function, or receptor-specific antagonists, which block receptor function, can have medically significant pharmacological effects.
Many tissues and immune cells located in the eye (and other places, for example the gut and kidney) express melanocortin receptors, empowering our opportunity to directly activate natural pathways to resolve disease inflammation.
About Diabetic (Nephropathy) Kidney Disease Diabetic nephropathy (DN) is the most common cause of end-stage renal disease in the United States and other developed countries. Approximately 30 million US patients have chronic kidney disease (CKD) secondary to the combination of hypertension and Type II diabetes mellitus. Despite this remarkable prevalence, clinicians have little consensus on what comprises optimal therapy. While the widespread use of RAAS blockade and other maneuvers have slowed disease progression, approximately one-third of patients with Type II diabetic nephropathy will progress to end-stage renal disease (ESRD). As a result, much effort has been devoted to understanding the mechanisms by which the diabetic condition leads to the typical histopathologic changes, including mesangial expansion, thickened basement membranes, and loss of podocyte density and functionality.
There is evidence that injury to the glomerular podocyte is central to the pathogenesis of diabetic nephropathy and that clinical treatments should be directed toward maintaining podocyte viability. Podocytes are highly differentiated neuron-like cells with limited cell division and replacement capacity. They are central to the support and maintenance of glomerular capillary networks and function as the final barrier in glomerular filtration. Evidence from pre-clinical animal model studies suggests that podocyte losses precede and contribute to progressive diabetic glomerulopathy.
About Melanocortins and Kidney Disease The melanocortin receptor system is comprised of 5 different receptors with broad and varying physiologic functions. MC1r signals through a G-protein coupled pathway that leads to activation of adenylate cyclase and ultimately stimulation of the serine-threonine kinase activity of protein kinase A. A growing body of work in cell signaling and function of the glomerular podocyte suggests that protein kinase A regulates the formation of footplate processes, cell attachment, and apoptosis. MC1r activation may stabilize podocyte function and survival in diabetes and other conditions of glomerular diseases.
About Palatin Palatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor systems, with targeted, receptor-specific product candidates for the treatment of diseases with significant unmet medical need and commercial potential. Palatin's strategy is to develop products and then form marketing collaborations to maximize their commercial potential. For additional information regarding Palatin, please visit Palatin's website at www.Palatin.com and follow Palatin on Twitter at @PalatinTech.
Forward-looking Statements Statements in this press release that are not historical facts, including statements about future expectations of Palatin Technologies, Inc., such as statements about Palatin products in development, clinical trial results, potential actions by regulatory agencies, regulatory plans, development programs, proposed indications for product candidates, and market potential for product candidates are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. Palatin intends that such forward-looking statements be subject to the safe harbors created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Palatin's actual results to be materially different from its historical results or from any results expressed or implied by such forward-looking statements. Palatin's actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, results of clinical trials, regulatory actions by the FDA and other regulatory and the need for regulatory approvals, Palatin's ability to fund development of its technology and establish and successfully complete clinical trials, the length of time and cost required to complete clinical trials and submit applications for regulatory approvals, products developed by competing pharmaceutical, biopharmaceutical and biotechnology companies, commercial acceptance of Palatin's products, and other factors discussed in Palatin's periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating events that occur after the date of this press release.
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