First Patient Dosed in Phase 2 Clinical Study of Palatin's Bremelanotide Co-Administered with Tirzepatide (GLP-1) for the Treatment of Obesity
Palatin Technologies (NYSE American: PTN) has initiated patient dosing in a Phase 2 clinical study of bremelanotide co-administered with tirzepatide for obesity treatment. The study, BMT-801, aims to enroll up to 60 patients across four U.S. sites, with full enrollment expected in Q3 2024 and topline results in Q1 2025. The primary endpoint is to demonstrate safety and increased efficacy of the co-administration on reducing body weight.
The company sees potential in combining MCR4 agonists with incretin therapeutics like tirzepatide for synergistic effects on weight loss, potentially allowing for increased weight loss at lower, better-tolerated doses. This approach aims to address the 67% discontinuation rate of GLP-1 agonists due to side effects and plateau effect in the first year.
Palatin Technologies (NYSE American: PTN) ha avviato la somministrazione di farmaci ai pazienti in uno studio clinico di Fase 2 del bremelanotide co-somministrato con tirzepatide per il trattamento dell'obesità. Lo studio, BMT-801, prevede l'arruolamento di fino a 60 pazienti in quattro sedi negli Stati Uniti, con completa arruolamento previsto per il terzo trimestre del 2024 e risultati preliminari attesi nel primo trimestre del 2025. L'obiettivo principale è dimostrare la sicurezza e l'aumento dell'efficacia della co-somministrazione nel ridurre il peso corporeo.
L'azienda vede potenziale nella combinazione di agonisti MCR4 con terapeutiche incretina come il tirzepatide per effetti sinergici sulla perdita di peso, consentendo potenzialmente una perdita di peso maggiore a dosi più basse e meglio tollerate. Questo approccio mira ad affrontare il tasso di interruzione del 67% degli agonisti GLP-1 a causa di effetti collaterali e dell'effetto plateau nel primo anno.
Palatin Technologies (NYSE American: PTN) ha iniciado la dosificación de pacientes en un estudio clínico de Fase 2 de bremelanotide coadministrado con tirzepatide para el tratamiento de la obesidad. El estudio, BMT-801, tiene como objetivo inscribir hasta 60 pacientes en cuatro sitios en EE.UU., con espera de inscripción completa para el tercer trimestre de 2024 y resultados preliminares en el primer trimestre de 2025. El objetivo principal es demostrar la seguridad y una mayor eficacia de la coadministración en la reducción del peso corporal.
La empresa ve potencial en la combinación de agonistas MCR4 con terapias incretinas como el tirzepatide para efectos sinérgicos en la pérdida de peso, lo que podría permitir una mayor pérdida de peso con dosis más bajas y mejor toleradas. Este enfoque busca abordar la tasa de discontinuación del 67% de los agonistas GLP-1 debido a efectos secundarios y al efecto meseta en el primer año.
팔라틴 기술(Palatin Technologies, NYSE American: PTN)은 비만 치료를 위한 브레멜라노타이드(bremelanotide)와 티르제파트이드(tirzepatide) 병용 투여의 2상 임상 시험에서 환자 투약을 시작했습니다. 이 연구(BMT-801)는 미국 내 4개 사이트에서 최대 60명의 환자를 모집할 예정이며, 2024년 3분기까지 전체 모집이 완료될 것으로 예상되며, 2025년 1분기에는 초기 결과가 발표될 것입니다. 주요 목표는 체중 감소에 대한 병용 투여의 안전성과 효능 증가를 입증하는 것입니다.
회사는 MCR4 작용제와 티르제파트이드와 같은 인크레틴 치료제를 결합하여 체중 감소에 대한 시너지 효과를 노릴 수 있는 가능성을 보고 있습니다. 이를 통해 더 낮고 더 잘 견딜 수 있는 용량에서 체중 감소를 증가시키는 것이 가능할 수 있습니다. 이 접근법은 1년 차에 유발되는 부작용과 플래토 효과로 인한 GLP-1 작용제의 67% 중단율 문제를 해결하려고 합니다.
Palatin Technologies (NYSE American: PTN) a commencé à administrer des doses aux patients dans une étude clinique de phase 2 sur le bremelanotide co-administré avec tirzepatide pour le traitement de l'obésité. L'étude, BMT-801, vise à recruter jusqu'à 60 patients sur quatre sites aux États-Unis, avec une inscription complète attendue au troisième trimestre 2024 et des résultats préliminaires au premier trimestre 2025. L'objectif principal est de démontrer la sécurité et l'augmentation de l'efficacité de la co-administration pour réduire le poids corporel.
L'entreprise voit un potentiel dans la combinaison de donneurs d'agents MCR4 avec des thérapies incrétiniques comme le tirzepatide pour des effets synergiques sur la perte de poids, permettant potentiellement une plus grande perte de poids à des doses plus faibles et mieux tolérées. Cette approche vise à résoudre le taux d'abandon de 67 % des agonistes GLP-1 en raison des effets secondaires et de l'effet plateau au cours de la première année.
Palatin Technologies (NYSE American: PTN) hat die Patientenverabreichung in einer Phase 2-Studie zu Bremelanotid, das zusammen mit Tirzepatid zur Behandlung von Fettleibigkeit verabreicht wird, begonnen. Die Studie BMT-801 soll bis zu 60 Patienten an vier Standorten in den USA rekrutieren, mit vollständiger Rekrutierung, die für das 3. Quartal 2024 erwartet wird und Ergebnissen im 1. Quartal 2025. Das Hauptziel besteht darin, die Sicherheit und die gesteigerte Wirksamkeit der Co-Verabreichung zur Gewichtsreduktion zu demonstrieren.
Das Unternehmen sieht Potenzial in der Kombination von MCR4-Agonisten mit Incretin-Therapeutika wie Tirzepatid für synergistische Effekte beim Gewichtsverlust, was möglicherweise größere Gewichtsverluste bei niedrigeren, besser verträglichen Dosen ermöglicht. Dieser Ansatz zielt darauf ab, die Abbruchrate von 67 % bei GLP-1-Agonisten aufgrund von Nebenwirkungen und dem Plateau-Effekt im ersten Jahr zu adressieren.
- Initiation of Phase 2 clinical trial for obesity treatment
- Potential synergistic effects of MCR4 agonists with incretin therapeutics
- Addressing high discontinuation rate of current obesity treatments
- Expansion into the growing obesity treatment market
- Full enrollment not expected until Q3 2024
- Topline results not expected until Q1 2025
- Competitive market with established GLP-1 agonists
Insights
The initiation of patient dosing in Palatin's Phase 2 clinical study for obesity treatment is a significant development. The study, combining bremelanotide with tirzepatide, targets the melanocortin 4 receptor (MCR4) and GLP-1/GIP pathways simultaneously. This approach could potentially address limitations of current GLP-1 therapies, including side effects and efficacy plateaus.
Key points to consider:
- The study aims to enroll 60 patients across 4 U.S. sites
- Primary endpoint: safety and increased efficacy in weight reduction
- Full enrollment expected by Q3 2024, with topline results in Q1 2025
- If successful, this combination therapy could offer a more sustainable weight loss solution
While promising, investors should note that Phase 2 results are still preliminary and success is not guaranteed. The obesity treatment market is highly competitive, but novel combination approaches could potentially capture significant market share if proven effective and well-tolerated.
Palatin's entry into the obesity treatment market with this Phase 2 study is strategically significant. The global obesity treatment market is projected to reach
- GLP-1 agonists like Wegovy and Ozempic have seen explosive growth, but face challenges with long-term adherence
67% of patients discontinue GLP-1 use within the first year due to side effects and efficacy plateaus- Combination therapies targeting multiple pathways could potentially address these limitations and capture market share
- Palatin's approach, if successful, could position them as a key player in next-generation obesity treatments
However, investors should be cautious. The obesity market is highly competitive with established players and multiple therapies in development. Palatin will need to demonstrate clear superiority or differentiation to gain significant traction. The timeline to potential commercialization is also lengthy, with Phase 3 trials and regulatory approvals still ahead.
- Complete enrollment currently expected in 3Q 2024
- Topline results expected in 1Q calendar year 2025
- Additional studies under assessment for multiple metabolic conditions
"We are excited with the start of patient dosing and by the level of patient and physician interest in our Phase 2 clinical study of an MCR4 agonist plus a GLP-1 to treat obese patients." said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. "The safe, effective, and consistent treatment and maintenance of weight loss will require multiple therapeutic options with differing mechanisms of action. The MCR4 pathway plays a key role in the regulation of energy storage and food intake, and we see MCR4 agonists playing an important role in future combination therapies and are advancing our novel long-acting peptide and small molecule compounds as key possible components of such combinations."
"The growth of GLP-1 agonists to treat obesity has been incredible and highly effective in the short run, but data shows that
The study is designed to enroll up to 60 patients at four trial sites in
Full patient enrollment in this Phase 2 clinical study of BMT-801 is currently expected in the third quarter of calendar year 2024 with topline data readout expected in the first half of calendar year 2025.
About Melanocortin 4 Receptor Agonists Effect on Obesity
Genetic analysis has identified the melanocortin 4 receptor (MCR4) of the paraventricular nucleus of the hypothalamus as playing a central role in appetite regulation. Genetic mutations that inhibit signaling in the MCR4 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 MCR4 that works with neuropeptide Y to stimulate appetite, whereas MCR4 agonists such as α- and β-melanocyte-stimulating hormone promote satiety. Agonism of the MCR4 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, MCR1 through MCR5. 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 Obesity
Obesity, which is defined as a body mass index (BMI) ≥30 kg/m2, represents a rising worldwide public health concern. Obesity is associated with an increased risk of overall mortality and serious health conditions, including high blood pressure, high cholesterol, type 2 diabetes, coronary heart disease, stroke and certain cancers. Health-related quality of life is significantly lower among adults with obesity, and obesity is associated with increased health care resource use and high economic burden. Safe and effective obesity treatments therefore remain a critical unmet need. The global increase in the prevalence of obesity is a public health issue that has severe cost implications to healthcare systems. In
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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