Palatin Provides Update on Anticipated 2025 Corporate Milestones
Palatin Technologies (NYSE: PTN) has outlined key milestones for 2025, focusing on its obesity treatment programs and other therapeutic areas. The company expects topline results from its Phase 2 BMT-801 clinical study, testing bremelanotide with tirzepatide for weight reduction, in Q1 2025.
The company plans to initiate multiple clinical trials in 2H 2025 with novel MC4R compounds for general obesity and rare genetic diseases. This strategy addresses the high discontinuation rate (67%) among current obesity treatments. Palatin will commence IND enabling activities in Q1 2025, with IND filings and Phase 1 studies targeted for later in the year.
Additionally, Palatin is pursuing licensing/collaboration deals for its dry eye disease, ulcerative colitis, and diabetic nephropathy programs. The company has received FDA agreement on endpoints for Phase 3 dry eye disease trials, set to begin in 1H 2025, and expects topline results from its Phase 2 ulcerative colitis study this quarter.
Palatin Technologies (NYSE: PTN) ha delineato le tappe principali per il 2025, concentrandosi sui suoi programmi di trattamento per l'obesità e altre aree terapeutiche. L'azienda si aspetta risultati preliminari dal suo studio clinico di Fase 2 BMT-801, che testa il bremelanotide con tirzepatide per la riduzione del peso, nel primo trimestre del 2025.
Palatin prevede di avviare più trial clinici nel secondo semestre del 2025 con nuovi composti MC4R per l'obesità generalizzata e malattie genetiche rare. Questa strategia affronta l'elevato tasso di abbandono (67%) tra i trattamenti attuali per l'obesità. Palatin inizierà le attività di abilitazione IND nel primo trimestre del 2025, con depositi IND e studi di Fase 1 previsti per la fine dell'anno.
Inoltre, Palatin sta perseguendo accordi di licenza/collaborazione per i suoi programmi di malattia degli occhi secchi, colite ulcerosa e nefropatia diabetica. L'azienda ha ricevuto l'accordo della FDA sugli endpoint per i trial di Fase 3 sulla malattia degli occhi secchi, che inizieranno nel primo semestre del 2025, e si aspetta risultati preliminari dal suo studio di Fase 2 sulla colite ulcerosa in questo trimestre.
Palatin Technologies (NYSE: PTN) ha delineado hitos clave para 2025, enfocándose en sus programas de tratamiento para la obesidad y otras áreas terapéuticas. La empresa espera resultados preliminares de su estudio clínico de Fase 2 BMT-801, que prueba bremelanotida con tirzepatida para la reducción de peso, en el primer trimestre de 2025.
La empresa planea iniciar múltiples ensayos clínicos en el segundo semestre de 2025 con nuevos compuestos MC4R para la obesidad en general y enfermedades genéticas raras. Esta estrategia aborda la alta tasa de discontinuación (67%) entre los tratamientos actuales para la obesidad. Palatin comenzará actividades de habilitación de IND en el primer trimestre de 2025, con presentaciones de IND y estudios de Fase 1 previstos para más adelante en el año.
Además, Palatin está buscando acuerdos de licencia/colaboración para sus programas de enfermedad ocular seca, colitis ulcerosa y nefropatía diabética. La empresa ha recibido la aprobación de la FDA sobre los puntos finales para los ensayos de Fase 3 de la enfermedad ocular seca, que comenzarán en el primer semestre de 2025, y espera resultados preliminares de su estudio de Fase 2 sobre la colitis ulcerosa este trimestre.
팔라틴 테크놀로지스 (NYSE: PTN)는 비만 치료 프로그램과 기타 치료 분야에 초점을 맞추어 2025년 주요 이정표를 제시했습니다. 이 회사는 2025년 1분기에 체중 감소를 위해 브레멜라노타이드와 티르제파타이드를 시험하는 2상 BMT-801 임상 연구에서 주요 결과를 기대하고 있습니다.
회사는 2025년 하반기에 일반 비만과 희귀 유전 질환을 위한 새로운 MC4R 화합물로 여러 임상 시험을 시작할 계획입니다. 이 전략은 현재 비만 치료의 높은 중단율(67%)을 해결하고자 합니다. 팔라틴은 2025년 1분기에 IND 활성화 활동을 시작하고, 연말에 IND 제출과 1상 연구를 목표로 하고 있습니다.
추가로, 팔라틴은 안구 건조증, 궤양성 대장염, 당뇨병성 신병증 프로그램에 대한 라이센스/협력 계약을 추구하고 있습니다. 회사는 2025년 상반기에 시작될 안구 건조증 3상 임상 시험의 기준점에 대해 FDA의 승인을 받았으며, 이번 분기에 2상 궤양성 대장염 연구의 주요 결과를 기대하고 있습니다.
Palatin Technologies (NYSE: PTN) a défini des étapes clés pour 2025, en se concentrant sur ses programmes de traitement de l'obésité et d'autres domaines thérapeutiques. La société s'attend à des résultats préliminaires de son étude clinique de Phase 2 BMT-801, testant le bremelanotide avec tirzepatide pour la réduction du poids, au premier trimestre 2025.
La société prévoit de lancer plusieurs essais cliniques au second semestre 2025 avec de nouveaux composés MC4R pour l'obésité générale et des maladies génétiques rares. Cette stratégie vise à aborder le taux élevé d'abandon (67%) parmi les traitements actuels de l'obésité. Palatin commencera des activités de validation d'IND au premier trimestre 2025, avec des dépôts d'IND et des études de Phase 1 prévues pour plus tard dans l'année.
De plus, Palatin poursuit des accords de licence/collaboration pour ses programmes de maladie des yeux secs, de colite ulcéreuse et de néphropathie diabétique. L'entreprise a reçu l'accord de la FDA sur les points d'extrémité pour les essais de Phase 3 sur la maladie des yeux secs, qui doivent commencer dans la première moitié de 2025, et s'attend à des résultats préliminaires de son étude de Phase 2 sur la colite ulcéreuse ce trimestre.
Palatin Technologies (NYSE: PTN) hat wichtige Meilensteine für 2025 umrissen, die sich auf seine Programme zur Behandlung von Fettleibigkeit und anderen therapeutischen Bereichen konzentrieren. Das Unternehmen erwartet im ersten Quartal 2025 vorläufige Ergebnisse aus seiner Phase 2 BMT-801-Studie, die Bremelanotid in Kombination mit Tirzepatid zur Gewichtsreduktion testet.
Das Unternehmen plant, in der zweiten Jahreshälfte 2025 mehrere klinische Studien mit neuartigen MC4R-Verbindungen für allgemeine Fettleibigkeit und seltene genetische Erkrankungen zu initiieren. Diese Strategie erfolgt als Antwort auf die hohe Abbruchrate (67%) bei den aktuellen Fettleibigkeitsbehandlungen. Palatin wird im ersten Quartal 2025 mit IND-fähigen Aktivitäten beginnen, wobei IND-Anmeldungen und Phase-1-Studien für später im Jahr angestrebt werden.
Zusätzlich verfolgt Palatin Lizenz-/Kooperationsvereinbarungen für seine Programme zur Behandlung von trockenen Augen, ulcerativer Kolitis und diabetischer Nephropathie. Das Unternehmen hat die Zustimmung der FDA zu den Endpunkten für Phase-3-Studien zur Behandlung trockener Augen erhalten, die in der ersten Jahreshälfte 2025 beginnen sollen, und erwartet in diesem Quartal vorläufige Ergebnisse aus seiner Phase-2-Studie zur ulcerativen Kolitis.
- Phase 2 BMT-801 obesity trial results expected in Q1 2025
- Multiple new clinical trials planned for 2H 2025
- FDA agreement secured for Phase 3 dry eye disease trial endpoints
- Multiple licensing/collaboration deals targeted for 2025
- None.
Insights
The upcoming milestones for Palatin Technologies represent a strategic positioning in the rapidly expanding obesity therapeutics market. The Phase 2 BMT-801 study combining bremelanotide with tirzepatide is particularly significant, as it addresses a critical market gap - the 67% discontinuation rate in current obesity treatments due to side effects and efficacy plateaus.
The scientific approach targeting MC4R is especially compelling. Unlike standalone GLP-1 agonists, Palatin's combination therapy strategy could potentially overcome the limitations of current treatments. The melanocortin system's fundamental role in energy regulation suggests this approach could provide more sustainable weight management outcomes.
Multiple value-driving catalysts are aligned for 2025: 1) Q1 topline results from the BMT-801 study 2) Multiple IND filings in H2 3) Potential licensing deals across various programs including dry eye disease and ulcerative colitis. The company's extensive IP portfolio and compound library in MC4R agonists provides significant strategic advantages.
From a market perspective, Palatin's focus on both general obesity and rare genetic obesity disorders creates multiple commercialization pathways. The orphan/rare disease approach could provide accelerated regulatory pathways and premium pricing opportunities, while the broader obesity market represents substantial commercial potential.
However, investors should note that success hinges heavily on the upcoming BMT-801 results, which will serve as a important validation point for Palatin's MC4R platform. The multiple planned IND filings in H2 2025 also suggest significant near-term capital requirements.
- Obesity programs:
- Phase 2 BMT-801 clinical study with MC4R agonist bremelanotide plus GLP-1/GIP dual agonist tirzepatide
- Topline results expected 1Q calendar year 2025
- General obesity, weight loss management, and rare neuroendocrine and genetic diseases, including hypothalamic obesity
- Multiple clinical trials targeted to commence 2H calendar year 2025 with long-acting MC4R peptide and/or MC4R oral small molecule compounds
- Phase 2 BMT-801 clinical study with MC4R agonist bremelanotide plus GLP-1/GIP dual agonist tirzepatide
- Dry eye disease and other ocular programs, ulcerative colitis, and diabetic nephropathy programs:
- Program specific licensing/collaboration and spinout discussions ongoing with multiple deals targeted for calendar year 2025
"We are poised for a transformational and defining year in 2025, focusing on reporting the topline data of our Phase 2 BMT-801 clinical study evaluating the co-administration of bremelanotide with tirzepatide on reducing body weight, with the readout expected later this quarter," said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. "The high discontinuation rate (
"The central melanocortin system has a fundamental role in regulating energy storage and feeding behaviors. MC4R is a well validated target for treating obesity with MC4R agonists having demonstrated in multiple clinical studies significant reductions in caloric intake and weight loss," continued Dr. Spana. "As the leading MCRS development company, Palatin has unique expertise, broad intellectual property coverage and an extensive library of compounds from which to draw to develop MC4R agonists for the treatment of obesity. Our novel MC4R agonists could play a vital role in treating obesity as monotherapy or in combination with existing treatments."
Expected 2025 Milestones
Obesity Programs
- Topline results from our Phase 2 BMT-801 'signal detection' clinical study with MC4R agonist bremelanotide plus a glucagon like peptide-1/gastric inhibitory polypeptide (GLP-1/GIP) dual agonist tirzepatide, expected in the first quarter of calendar year 2025.
- Primary objective: Demonstrate that co-administration of bremelanotide with tirzepatide is safe and has a significant effect on reducing body weight.
- General obesity, weight loss management, and orphan/rare neuroendocrine and genetic diseases, including hypothalamic obesity:
- Potential for monotherapy or combination (with a GLP-1 agonist) therapy.
- Investigational new drug (IND) enabling activities expected to commence 1Q calendar year 2025.
- Filing of INDs anticipated 2H of calendar year 2025.
- Commencement of Phase 1 clinical studies targeted for 4Q calendar year 2025.
Dry eye disease (DED) and other ocular programs, ulcerative colitis (UC), and diabetic nephropathy programs
- Program specific licensing/collaboration and spinout activities ongoing with multiple deals targeted for calendar year 2025.
- DED
- Concluded positive Type C meeting with the FDA and reached agreement on sign and symptom endpoints for remaining two Phase 3 pivotal trial protocols, with patient enrollment prepared to commence 1H calendar year 2025.
- UC
- Report topline results from our Phase 2 clinical study of PL8177 oral formulation for the treatment of UC later this quarter.
About Melanocortin 4 Receptor Agonists Effect on Obesity
Genetic analysis has identified the melanocortin 4 receptor (MC4R) of the paraventricular nucleus of the hypothalamus as playing a central role in appetite regulation. Genetic mutations that inhibit signaling in the MC4R pathway lead to hyperphagia, decreased energy expenditure and early-onset obesity; such mutations have been identified as the cause of several rare genetic obesity disorders. Agouti-related peptide is an endogenous antagonist of the MC4R that works with neuropeptide Y to stimulate appetite, whereas MC4R agonists such as α- and β-melanocyte-stimulating hormone promote satiety. Agonism of the MC4R therefore represents an attractive target for potential obesity treatments.
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 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 with industry leaders 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 including the FDA, 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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SOURCE Palatin Technologies, Inc.
FAQ
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