Palatin to Present Positive Phase 2b Data for Melanocortin Agonist in Diabetic Kidney Disease at the National Kidney Foundation Spring Meeting
Palatin Technologies (NYSE American: PTN) announced positive Phase 2b BREAKOUT study results for their melanocortin agonist treatment in Type 2 diabetic nephropathy patients. The six-month open-label study demonstrated significant improvements in kidney function:
- 71% of patients achieved >30% reduction in urine protein to creatinine ratio (UP/Cr)
- 71% showed improved or stabilized estimated glomerular filtration rate (eGFR)
- 37.5% experienced increased urinary VEGF levels
- 36% demonstrated reduced urinary synaptopodin loss
The study enrolled 16 patients with confirmed Type 2 diabetic nephropathy and >1000 mg/gm UP/Cr ratio, with 8 completing the six-month treatment. The treatment involved subcutaneous bremelanotide administration twice daily alongside maximum tolerated RAAS inhibition therapy.
Palatin Technologies (NYSE American: PTN) ha annunciato risultati positivi dello studio di Fase 2b BREAKOUT per il loro trattamento con agonista melanocortinico nei pazienti con nefropatia diabetica di tipo 2. Lo studio aperto di sei mesi ha dimostrato significativi miglioramenti nella funzione renale:
- Il 71% dei pazienti ha ottenuto una riduzione >30% del rapporto proteine urinarie su creatinina (UP/Cr)
- Il 71% ha mostrato un miglioramento o stabilizzazione della velocità di filtrazione glomerulare stimata (eGFR)
- Il 37,5% ha registrato un aumento dei livelli di VEGF urinario
- Il 36% ha dimostrato una riduzione della perdita di sinaptopodina urinaria
Lo studio ha arruolato 16 pazienti con nefropatia diabetica di tipo 2 confermata e un rapporto UP/Cr >1000 mg/gm, con 8 pazienti che hanno completato il trattamento di sei mesi. Il trattamento prevedeva l'amministrazione sottocutanea di bremelanotide due volte al giorno insieme alla terapia di inibizione RAAS massimamente tollerata.
Palatin Technologies (NYSE American: PTN) anunció resultados positivos del estudio de Fase 2b BREAKOUT para su tratamiento con agonista melanocortínico en pacientes con nefropatía diabética tipo 2. El estudio abierto de seis meses demostró mejoras significativas en la función renal:
- El 71% de los pacientes logró una reducción >30% en la relación de proteínas urinarias a creatinina (UP/Cr)
- El 71% mostró una mejora o estabilización de la tasa de filtración glomerular estimada (eGFR)
- El 37,5% experimentó un aumento en los niveles de VEGF urinario
- El 36% demostró una reducción en la pérdida de sinaptopodina urinaria
El estudio inscribió a 16 pacientes con nefropatía diabética tipo 2 confirmada y una relación UP/Cr >1000 mg/gm, con 8 completando el tratamiento de seis meses. El tratamiento consistió en la administración subcutánea de bremelanotida dos veces al día junto con la terapia de inhibición RAAS tolerada al máximo.
Palatin Technologies (NYSE American: PTN)는 제2형 당뇨병 신병증 환자를 위한 멜라노코르틴 작용제 치료의 2b 단계 BREAKOUT 연구 결과가 긍정적이라고 발표했습니다. 6개월간의 공개 연구에서 신장 기능의 유의미한 개선이 나타났습니다:
- 71%의 환자가 소변 단백질 대 크레아티닌 비율(UP/Cr)에서 >30% 감소를 달성했습니다.
- 71%는 추정 사구체 여과율(eGFR)이 개선되거나 안정화되었습니다.
- 37.5%는 소변 VEGF 수준이 증가했습니다.
- 36%는 소변에서 신경세포 소실이 감소했습니다.
이 연구는 확인된 제2형 당뇨병 신병증 환자 16명을 등록하였고, UP/Cr 비율이 >1000 mg/gm인 환자들 중 8명이 6개월 치료를 완료했습니다. 치료는 최대 내약성 RAAS 억제 요법과 함께 하루 두 번의 피하 브레멜라노타이드 투여를 포함했습니다.
Palatin Technologies (NYSE American: PTN) a annoncé des résultats positifs de l'étude de Phase 2b BREAKOUT pour leur traitement par agoniste des mélanocortines chez des patients atteints de néphropathie diabétique de type 2. L'étude ouverte de six mois a démontré des améliorations significatives de la fonction rénale :
- 71% des patients ont atteint une réduction >30% du rapport protéines urinaires sur créatinine (UP/Cr)
- 71% ont montré une amélioration ou une stabilisation du taux de filtration glomérulaire estimé (eGFR)
- 37,5% ont connu une augmentation des niveaux de VEGF urinaire
- 36% ont montré une réduction de la perte de synaptopodine urinaire
L'étude a inclus 16 patients avec une néphropathie diabétique de type 2 confirmée et un rapport UP/Cr >1000 mg/gm, dont 8 ont complété le traitement de six mois. Le traitement impliquait l'administration sous-cutanée de bremelanotide deux fois par jour avec une thérapie d'inhibition RAAS tolérée au maximum.
Palatin Technologies (NYSE American: PTN) hat positive Ergebnisse der Phase 2b BREAKOUT-Studie für ihre melanocortin-Agonistenbehandlung bei Patienten mit diabetischer Nephropathie Typ 2 bekannt gegeben. Die sechsmonatige offene Studie zeigte signifikante Verbesserungen der Nierenfunktion:
- 71% der Patienten erreichten eine >30%ige Reduktion des Verhältnisses von Urinprotein zu Kreatinin (UP/Cr)
- 71% zeigten eine Verbesserung oder Stabilisierung der geschätzten glomerulären Filtrationsrate (eGFR)
- 37,5% erlebten erhöhte Urin-VEGF-Spiegel
- 36% wiesen eine Verringerung des Verlusts von Synaptopodin im Urin auf
Die Studie umfasste 16 Patienten mit bestätigter diabetischer Nephropathie Typ 2 und einem UP/Cr-Verhältnis von >1000 mg/gm, von denen 8 die sechsmonatige Behandlung abschlossen. Die Behandlung bestand aus der subkutanen Verabreichung von Bremelanotid zweimal täglich zusammen mit einer maximal tolerierten RAAS-Hemotherapie.
- 71% of patients showed significant improvement in kidney damage markers (UP/Cr reduction)
- 71% demonstrated preserved kidney function through improved/stabilized eGFR
- Study represents third major clinical milestone across different therapeutic areas
- Treatment shows potential to slow disease progression in diabetic nephropathy
- Small patient sample size (only 8 completed the trial)
- 50% dropout rate from initial enrollment (8 of 16 patients completed)
- Open-label study design may introduce bias
- duration of study (six months) for a chronic condition
Insights
Palatin's Phase 2b BREAKOUT study represents an interesting development in diabetic nephropathy, though with important caveats. The trial explored bremelanotide's potential to address podocyte dysfunction—a critical cellular mechanism in diabetic kidney disease progression.
The reported 71% response rate for UP/Cr reduction and 71% showing stabilized/improved eGFR are clinically meaningful signals, as proteinuria reduction correlates with slowed disease progression. The biomarker improvements (VEGF and synaptopodin) align with the proposed mechanism of podocyte preservation.
However, this enthusiasm must be tempered by the extremely small sample size (only 8 completers from 16 enrolled), representing a concerning 50% dropout rate. The open-label design without a control arm introduces potential bias, making it impossible to distinguish true drug effect from placebo response or background therapy effects.
The melanocortin receptor system represents a novel approach in nephrology, targeting inflammatory and structural kidney pathways differently than standard RAAS inhibitors. If these signals hold up in larger, controlled studies, it could offer a complementary approach to existing therapies for the approximately 30 million US patients with diabetic kidney disease, potentially addressing the one-third who progress to end-stage renal disease despite current treatments.
This Phase 2b data adds another potential indication to Palatin's melanocortin platform, joining positive signals in obesity, ulcerative colitis, and their advancing dry eye program. For a microcap company (
The diabetic nephropathy results show encouraging biomarker improvements, but investors should recognize the substantial limitations: the tiny sample size (only 8 completers), open-label design (no placebo control), and 50% dropout rate. While presented as a "major clinical milestone," this represents very preliminary efficacy data requiring validation in larger, controlled studies.
Strategically, this strengthens Palatin's platform thesis that melanocortin receptor modulation may address multiple inflammatory and metabolic conditions. However, the company faces significant development challenges across multiple programs with resources. The diabetic kidney disease market represents a substantial opportunity but would require significant capital for pivotal trials.
For Palatin shareholders, these results primarily serve as incremental validation of their scientific approach rather than a near-term value driver. With three distinct therapeutic areas showing positive signals, the company may become more attractive for partnerships or additional financing to advance these programs, though substantial dilution risks remain given their current capitalization.
- 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.
"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 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
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.
Palatin Technologies® is a registered trademark of Palatin Technologies, Inc.
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