Palatin Completes Phase 2 Obesity Study With MC4R Bremelanotide Plus GLP-1/GIP Tirzepatide
Palatin Technologies (NYSE American: PTN) has completed its Phase 2 BMT-801 clinical study examining the co-administration of MC4R bremelanotide with GLP-1/GIP tirzepatide for obesity treatment. The study enrolled 113 patients, with 96 randomized across four U.S. clinical sites - nearly double the initial target of 60 patients due to strong demand.
The primary endpoint focuses on demonstrating safety and efficacy in reducing body weight. The study design included a four-week tirzepatide-only treatment period, followed by randomization into four treatment regimens. Topline data results are expected later this quarter.
The company believes the combination of MC4R + GLP-1/GIP agonists may show additive and synergistic effects on patient weight loss. The results will inform planned clinical programs for treating general obesity, weight loss management, hypothalamic obesity, and potential rare MC4R pathway diseases.
Palatin Technologies (NYSE American: PTN) ha completato il suo studio clinico di Fase 2 BMT-801 che esamina la co-somministrazione di bremelanotide MC4R con tirzepatide GLP-1/GIP per il trattamento dell'obesità. Lo studio ha arruolato 113 pazienti, con 96 randomizzati in quattro centri clinici negli Stati Uniti - quasi il doppio dell'obiettivo iniziale di 60 pazienti a causa della forte domanda.
Il principale obiettivo dello studio si concentra sulla dimostrazione della sicurezza e dell'efficacia nella riduzione del peso corporeo. Il disegno dello studio prevedeva un periodo di trattamento di quattro settimane solo con tirzepatide, seguito dalla randomizzazione in quattro schemi di trattamento. I risultati preliminari sono attesi entro la fine di questo trimestre.
La società ritiene che la combinazione di agonisti MC4R + GLP-1/GIP possa mostrare effetti additivi e sinergici nella perdita di peso dei pazienti. I risultati informeranno i programmi clinici pianificati per il trattamento dell'obesità generale, la gestione della perdita di peso, l'obesità ipotalamica e potenziali malattie rare del percorso MC4R.
Palatin Technologies (NYSE American: PTN) ha completado su estudio clínico de Fase 2 BMT-801 que examina la co-administración de bremelanotida MC4R con tirzepatida GLP-1/GIP para el tratamiento de la obesidad. El estudio incluyó 113 pacientes, con 96 aleatorizados en cuatro sitios clínicos de EE. UU. - casi el doble del objetivo inicial de 60 pacientes debido a una fuerte demanda.
El objetivo principal se centra en demostrar la seguridad y eficacia en la reducción del peso corporal. El diseño del estudio incluyó un período de tratamiento de cuatro semanas solo con tirzepatida, seguido de la aleatorización en cuatro regímenes de tratamiento. Se esperan los resultados preliminares más adelante este trimestre.
La compañía cree que la combinación de agonistas MC4R + GLP-1/GIP puede mostrar efectos aditivos y sinérgicos en la pérdida de peso de los pacientes. Los resultados informarán sobre los programas clínicos planificados para tratar la obesidad general, la gestión de la pérdida de peso, la obesidad hipotalámica y posibles enfermedades raras de la vía MC4R.
팔라틴 테크놀로지스 (NYSE American: PTN)는 비만 치료를 위한 GLP-1/GIP 티르제파타이드와 MC4R 브레멜라노타이드의 동시 투여를 조사하는 2상 BMT-801 임상 연구를 완료했습니다. 이 연구에는 113명의 환자가 등록되었으며, 96명이 미국 내 4개의 임상 사이트에 무작위 배정되었습니다. 이는 강력한 수요로 인해 초기 목표인 60명의 거의 두 배에 해당합니다.
주요 목표는 체중 감소의 안전성과 효능을 입증하는 것입니다. 연구 설계에는 4주간의 티르제파타이드 단독 치료 기간이 포함되었고 이후 4개의 치료 요법으로 무작위 배정되었습니다. 주요 데이터 결과는 이번 분기 말에 발표될 예정입니다.
회사는 MC4R + GLP-1/GIP 작용제의 조합이 환자의 체중 감소에 대해 추가적이고 시너지 효과를 나타낼 수 있다고 믿습니다. 결과는 일반 비만 치료, 체중 감소 관리, 시상하부 비만 및 잠재적인 드문 MC4R 경로 질환 치료를 위한 계획된 임상 프로그램에 대한 정보로 사용될 것입니다.
Palatin Technologies (NYSE American: PTN) a achevé son étude clinique de Phase 2 BMT-801 examinant la co-administration de bremelanotide MC4R avec tirzepatide GLP-1/GIP pour le traitement de l'obésité. L'étude a inclus 113 patients, dont 96 randomisés dans quatre sites cliniques aux États-Unis - presque le double de l'objectif initial de 60 patients en raison d'une forte demande.
L'objectif principal se concentre sur la démonstration de la sécurité et de l'efficacité dans la réduction du poids corporel. Le design de l'étude comprenait une période de traitement de quatre semaines uniquement avec tirzepatide, suivie d'une randomisation dans quatre régimes de traitement. Les résultats préliminaires sont attendus plus tard ce trimestre.
La société estime que la combinaison d'agonistes MC4R + GLP-1/GIP pourrait montrer des effets additifs et synergiques sur la perte de poids des patients. Les résultats informeront les programmes cliniques prévus pour traiter l'obésité générale, la gestion du poids, l'obésité hypothalamique et les maladies rares potentielles du chemin MC4R.
Palatin Technologies (NYSE American: PTN) hat die Phase-2-Studie BMT-801 abgeschlossen, die die Co-Administration von MC4R-Bremelanotid mit GLP-1/GIP-Tirzepatide zur Behandlung von Fettleibigkeit untersucht. An der Studie nahmen 113 Patienten teil, wobei 96 über vier klinische Standorte in den USA randomisiert wurden – fast doppelt so viel wie das ursprüngliche Ziel von 60 Patienten aufgrund der hohen Nachfrage.
Das primäre Ziel konzentriert sich darauf, Sicherheit und Wirksamkeit bei der Reduzierung des Körpergewichts zu demonstrieren. Das Studiendesign beinhaltete eine vierwöchige Behandlungsperiode nur mit Tirzepatide, gefolgt von einer Randomisierung in vier Behandlungsregime. Die ersten Zwischenergebnisse werden noch in diesem Quartal erwartet.
Das Unternehmen glaubt, dass die Kombination von MC4R + GLP-1/GIP-Agonisten additive und synergistische Effekte auf den Gewichtsverlust der Patienten zeigen könnte. Die Ergebnisse werden die geplanten klinischen Programme zur Behandlung von allgemeiner Fettleibigkeit, Gewichtsmanagement, hypothalamischer Fettleibigkeit und potenziellen seltenen Erkrankungen des MC4R-Weges informieren.
- Study enrollment exceeded initial target by nearly 100% (113 vs 60 patients) due to strong demand
- Phase 2 clinical trial completed with topline data expected in current quarter
- Multiple potential applications including general obesity, weight management, and rare diseases
- None.
Insights
The completion of PTN's Phase 2 obesity study marks a pivotal moment in the evolution of combination approaches for weight management. The notably high enrollment of 113 patients (nearly double the target) suggests strong investigator and patient interest, potentially indicating significant market demand for novel obesity treatments.
The study's scientific premise is particularly compelling. While GLP-1/GIP agonists like tirzepatide work primarily through appetite regulation and metabolic modulation, MC4R agonists target a distinct neurological pathway in the hypothalamus that controls energy homeostasis. This dual-mechanism approach could potentially address the limitations of current monotherapies, where weight loss often plateaus.
The timing is strategically significant, as the obesity treatment market is experiencing unprecedented growth. With current GLP-1 therapies showing 15-20% weight loss, any additive or synergistic effects from the combination could position PTN favorably in this rapidly expanding market. The study's results could also validate PTN's broader platform of MC4R agonists, including their development of long-acting peptides and oral small molecules.
The inclusion of multiple assessment endpoints beyond weight loss suggests a comprehensive evaluation of the combination's effects on overall metabolic health. This thorough approach could provide valuable insights for treating various obesity subtypes, including rare genetic conditions linked to MC4R pathway dysfunction.
The completion of this Phase 2 study represents a important inflection point for PTN's market position in the rapidly growing obesity therapeutics sector. The successful over-enrollment not only accelerates the development timeline but also demonstrates strong clinical interest in this novel combination approach.
From a commercial perspective, PTN's strategy of combining their MC4R agonist with established GLP-1/GIP therapy is particularly astute. Rather than competing directly with market leaders, they're positioning their technology as a complementary solution that could enhance existing treatments. This approach could facilitate faster market adoption and potential partnership opportunities with major players in the obesity space.
The broader implications for PTN's pipeline are significant. Success in this study could validate their MC4R platform technology, potentially leading to applications in multiple indications beyond obesity. The company's focus on both long-acting peptides and oral small molecules provides multiple shots on goal and flexibility in development strategies.
The timing of this data readout is particularly opportune given the current market dynamics in the obesity sector. With major pharmaceutical companies actively seeking to expand their presence in this space, positive results could position PTN as an attractive partner or acquisition target.
- Last Patient / Last Visit Completed
- Topline Data Readout Expected Later This Quarter
Topline data results from the Phase 2 BMT-801 entitled "BMT-801, A Phase II, Randomized, Double-Blind, Placebo-Controlled, Clinical Study Investigating the Safety, Tolerability, and Effectiveness of the Co-Administration of Bremelanotide with Tirzepatide (GLP-1/GIP) for the Treatment of Obesity" are expected later this quarter. The study enrolled a total of 113 patients, with 96 patients randomized. The patient enrollment number is approximately twice the initial target of 60 patients, primarily due to strong patient demand and efficiency at the four
"We are pleased to announce last patient/last visit in our Phase 2 obesity study and look forward to sharing the study data later this quarter," said Carl Spana, Ph.D., President & Chief Executive Officer of Palatin. "We believe the data from this study will demonstrate that the combination of MC4R + GLP-1/GIP agonists may result in additive and synergistic effects on patient weight loss, and importantly, will inform and support our planned clinical programs and development programs under assessment for treating general obesity, weight loss management, acquired and congenital hypothalamic obesity, and potentially, rare/orphan genetically caused MC4R pathway diseases."
"There is a clear and unmet medical need for alternative mechanisms of action that can provide physicians and patients with improved overall health outcomes in the pursuit of weight loss beyond those achieved with GLP-1 and GIP drugs," continued Dr. Spana. "The MC4R pathway plays a key role in eating behavior and how our bodies manage energy. As a result, we believe that MC4R agonists, especially the highly selective MC4R long-acting peptides and oral small molecule agonists we are developing, will play an important role for treating obesity as monotherapy and/or combination therapy."
The primary endpoint of the Phase 2 BMT-801 clinical trial is to demonstrate the safety and efficacy of co-administration of bremelanotide with tirzepatide on reducing body weight. Patients were treated with tirzepatide-only for four weeks, had eligibility confirmed, then were randomized to one of four treatment regimens. Patients underwent multiple assessments of safety and efficacy to help profile the effectiveness of bremelanotide in treating general obesity as a stand-alone treatment or in conjunction with GLP-1/GIP therapy. Additional trial information can be found at https://clinicaltrials.gov via the identifier NCT06565611.
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. MC4R agonism 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.
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, 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.
View original content to download multimedia:https://www.prnewswire.com/news-releases/palatin-completes-phase-2-obesity-study-with-mc4r-bremelanotide-plus-glp-1gip-tirzepatide-302369916.html
SOURCE Palatin Technologies, Inc.
FAQ
What are the primary endpoints of Palatin's Phase 2 BMT-801 obesity trial?
How many patients were enrolled in PTN's Phase 2 obesity study?
When will Palatin (PTN) release the topline data for its Phase 2 obesity study?
What is the mechanism of action in Palatin's obesity treatment study?
What potential applications does Palatin's obesity treatment target?
