Palatin Announces Positive Results From Phase IIb BREAKOUT Study
In patients with type 2 diabetic nephropathy, bremelanotide demonstrated efficacy in reducing urine protein to creatinine ratio and improving or stabilizing estimated glomerular filtration rate.
Palatin has shared topline data from the Phase IIb BREAKOUT clinical trial, assessing the safety, tolerability, and efficacy of bremelanotide in patients with type 2 diabetic nephropathy.1
According to the data, bremelanotide therapy for six months produced positive results related to worsening kidney function and disease progression. A majority of the patients achieved a >30% reduction in urine protein to creatinine ratio (UP/Cr) as well as an improved or stabilized estimated glomerular filtration rate (eGFR). Patients in the study also experienced increased urinary vascular endothelial growth factor (VEGF) and reduced urinary synaptopodin losses.
In a press release, Carl Spana, PhD, president and CEO of Palatin said, "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. 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 III dry eye disease trial earlier this year. Lastly, patient enrollment in our Phase II ulcerative colitis (UC) trial is complete, with topline data targeted for release in the first quarter of calendar year 2025."
BREAKOUT is a multicenter, open-label, prospective study of bremelanotide in diabetic kidney disease. The trial enrolled 16 patients with confirmed type 2 diabetic nephropathy with 8 patients completing the six-month treatment regimen. Patients received bremelanotide subcutaneously twice daily plus their maximum tolerated dose of renin-angiotensin-aldosterone system (RAAS) inhibition therapy.
"The findings from this study are consistent with previous studies that the activation of melanocortin receptors can result in positive effects on kidney function by positively effecting synaptopodin and podocyte function," James A. Tumlin MD, CEO and founder of NephroNet Clinical Trials Consortium, added in the press release. "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."
As mentioned by Spana, Palatin announced it had completed enrollment for its multi-center, randomized, double-blind, placebo-controlled, adaptive design Phase II trial in UC in November. The study will be evaluating PL8177, a potent melanocortin-1 receptor (MC1R) agonist, over the course of eight weeks. Palatin expects the last patient visit to occur in the first quarter of 2025, with topline data expected shortly after.2
“Prior data has demonstrated that oral PL8177 caused diseased colons to move towards a healthy state and resolved damaging inflammation. By resolving inflammation rather than blocking it, oral PL8177 may provide efficacy to patients without the safety and tolerability concerns of immunosuppressive therapies and steroid treatments, which have significant safety and tolerability concerns. Additionally, oral PL8177, as a preferable and more convenient once-daily pill, could provide an alternative to UC patients apprehensive about using injectable therapies,” Spana said in an earlier press release.
References
1. Palatin Announces Positive Phase IIb BREAKOUT Study Results in Patients with Type 2 Diabetic Nephropathy. News release. Palatin. December 19, 2024. Accessed December 19, 2024. https://www.prnewswire.com/news-releases/palatin-announces-positive-phase-iib-breakout-study-results-in-patients-with-type-2-diabetic-nephropathy-302335925.html
2. Palatin Announces Completion of Patient Enrollment in Phase 2 Study of Orally Administered Melanocortin Agonist PL8177 in Ulcerative Colitis. News release. Palatin. November 25, 2024. Accessed December 19, 2024. https://www.prnewswire.com/news-releases/palatin-announces-completion-of-patient-enrollment-in-phase-2-study-of-orally-administered-melanocortin-agonist-pl8177-in-ulcerative-colitis-302314718.html
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