Palatin Technologies has announced topline results for the phase 2b Breakout study, which evaluated the effects of bremelanotide in patients with type 2 diabetic nephropathy. This condition is a severe complication of diabetes and the leading cause of renal failure in end-stage renal disease, however, there is currently no treatment that can achieve a complete cure for it.
The Breakout clinical trial enrolled 16 patients with type 2 diabetic nephropathy, with eight patients completing the full six-month treatment regimen, which consisted of twice-daily subcutaneous injections of bremelanotide.
Over the course of six months, 71% of patients achieved clinically meaningful endpoints, including a reduction in the urine protein to creatinine ratio and an improved estimated glomerular filtration rate.
Treatment for diabetic nephropathy patients
“With diabetic nephropathy being one of the leading causes of end-stage renal disease across the world, this positive data supports the further development of a melanocortin agonist like bremelanotide, without melanocortin-2 receptor agonism, as a potential treatment option for diabetic nephropathy patients,” says James A Tumlin, CEO and founder of the NephroNet Clinical Trials Consortium.
Palatin’s technology platform focuses on targeting the melanocortin system, which is responsible for controlling inflammation, immune response, metabolism, steroid hormone production and sexual function. Bremelanotide is an agonist drug that targets all the five melanocortin receptors except for the melanocortin 2 receptor.
In 2019, bremelanotide received FDA approval under the brand name Vyleesi as a treatment for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Palatin continues to develop bremelanotide and other drug candidates targeting the melanocortin system for a wide range of indications including ophthalmic and metabolic conditions. Phase 2 data from an ongoing trial in ulcerative colitis is expected in the first quarter of 2025.
A new therapeutic strategy
“The data from this trial is encouraging and validates that modulating the melanocortin system could potentially be a new therapeutic strategy and possibly disease-modifying treatment option for people living with this progressive kidney disease,” said Carl Spana, President and CEO of Palatin Technologies.
“Targeting the melanocortin system in autoimmune and inflammation conditions reduces cellular stress, resolves inflammation and promotes tissue repair. Our melanocortin pipeline has demonstrated preclinical efficacy in over 10 disease models, including positive clinical results in this phase IIb diabetic nephropathy study and our MELODY-1 phase 3 dry eye disease trial earlier this year.”
