Palatin Reports Positive Appetite Suppression Results From Phase 2 Obesity Study of MC4R Agonist Bremelanotide and Tirzepatide
Palatin Technologies (NYSE American: PTN) has announced positive appetite suppression results from its BMT-801 Phase 2 obesity study evaluating the co-administration of melanocortin 4 receptor (MC4R) agonist bremelanotide with GLP-1/GIP tirzepatide.
Key findings show significant improvements in appetite suppression across all treatment arms:
- Bremelanotide + tirzepatide: 71% increase
- Tirzepatide only: 73% increase
- Bremelanotide only: 71% increase
Notably, low-dose bremelanotide demonstrated effectiveness in preventing weight regain after tirzepatide discontinuation, while patients on tirzepatide alone regained over 50% of lost weight within two weeks of stopping treatment. The company plans to advance its next-generation MC4R agonists pipeline, with IND filings expected by Q4 2025 and initial clinical data in H1 2026.
Palatin Technologies (NYSE American: PTN) ha annunciato risultati positivi riguardo alla soppressione dell'appetito nel suo studio di fase 2 BMT-801 sull'obesità, che valuta la somministrazione congiunta dell'agonista del recettore melanocortina 4 (MC4R) bremelanotide insieme a tirzepatide, un agonista GLP-1/GIP.
I risultati principali mostrano miglioramenti significativi nella soppressione dell'appetito in tutti i gruppi di trattamento:
- Bremelanotide + tirzepatide: aumento del 71%
- Solo tirzepatide: aumento del 73%
- Solo bremelanotide: aumento del 71%
È importante sottolineare che il bremelanotide a basse dosi si è dimostrato efficace nel prevenire la ripresa del peso dopo la sospensione del tirzepatide, mentre i pazienti trattati solo con tirzepatide hanno recuperato oltre il 50% del peso perso entro due settimane dalla fine del trattamento. L'azienda prevede di sviluppare ulteriormente la sua pipeline di agonisti MC4R di nuova generazione, con la presentazione delle IND prevista entro il quarto trimestre del 2025 e i primi dati clinici attesi nella prima metà del 2026.
Palatin Technologies (NYSE American: PTN) ha anunciado resultados positivos en la supresión del apetito en su estudio de fase 2 BMT-801 sobre obesidad, que evalúa la coadministración del agonista del receptor melanocortina 4 (MC4R) bremelanotida junto con tirzepatida, un agonista de GLP-1/GIP.
Los hallazgos clave muestran mejoras significativas en la supresión del apetito en todos los grupos de tratamiento:
- Bremelanotida + tirzepatida: aumento del 71%
- Solo tirzepatida: aumento del 73%
- Solo bremelanotida: aumento del 71%
Es destacable que la bremelanotida en dosis bajas demostró ser efectiva para prevenir la recuperación de peso tras la suspensión de tirzepatida, mientras que los pacientes tratados solo con tirzepatida recuperaron más del 50% del peso perdido en dos semanas después de finalizar el tratamiento. La empresa planea avanzar en su línea de agonistas MC4R de próxima generación, con presentaciones IND previstas para el cuarto trimestre de 2025 y los primeros datos clínicos en la primera mitad de 2026.
Palatin Technologies (NYSE American: PTN)는 멜라노코르틴 4 수용체(MC4R) 작용제 브레멜라노타이드와 GLP-1/GIP 작용제인 티르제파타이드의 병용 투여를 평가하는 비만 대상 BMT-801 2상 임상시험에서 식욕 억제 효과가 긍정적으로 나타났다고 발표했습니다.
주요 결과는 모든 치료군에서 식욕 억제 효과가 크게 향상되었음을 보여줍니다:
- 브레멜라노타이드 + 티르제파타이드: 71% 증가
- 티르제파타이드 단독: 73% 증가
- 브레멜라노타이드 단독: 71% 증가
특히, 저용량 브레멜라노타이드는 티르제파타이드 중단 후 체중 재증가를 방지하는 데 효과적이었으며, 티르제파타이드 단독 투여 환자들은 치료 중단 후 2주 이내에 잃은 체중의 50% 이상을 다시 회복했습니다. 회사는 차세대 MC4R 작용제 파이프라인을 개발할 계획이며, IND 제출은 2025년 4분기까지, 초기 임상 데이터는 2026년 상반기에 발표될 예정입니다.
Palatin Technologies (NYSE American : PTN) a annoncé des résultats positifs concernant la suppression de l'appétit dans son étude de phase 2 BMT-801 sur l'obésité, évaluant la co-administration de l'agoniste du récepteur mélanocortine 4 (MC4R) bremélanotide avec le tirzépatide, un agoniste GLP-1/GIP.
Les résultats clés montrent des améliorations significatives de la suppression de l'appétit dans tous les groupes de traitement :
- Bremélanotide + tirzépatide : augmentation de 71 %
- Tirzépatide seul : augmentation de 73 %
- Bremélanotide seul : augmentation de 71 %
Il est notable que le bremélanotide à faible dose a démontré son efficacité pour prévenir la reprise de poids après l'arrêt du tirzépatide, tandis que les patients traités uniquement par tirzépatide ont repris plus de 50 % du poids perdu dans les deux semaines suivant l'arrêt du traitement. La société prévoit de faire progresser sa pipeline d'agonistes MC4R de nouvelle génération, avec des dépôts IND attendus d'ici le quatrième trimestre 2025 et les premières données cliniques au premier semestre 2026.
Palatin Technologies (NYSE American: PTN) hat positive Ergebnisse zur Appetitunterdrückung aus der Phase-2-Studie BMT-801 bei Adipositas bekannt gegeben, in der die gleichzeitige Verabreichung des Melanocortin-4-Rezeptor (MC4R) Agonisten Bremelanotid zusammen mit dem GLP-1/GIP Agonisten Tirzepatid untersucht wurde.
Wesentliche Ergebnisse zeigen signifikante Verbesserungen der Appetitunterdrückung in allen Behandlungsgruppen:
- Bremelanotid + Tirzepatid: 71% Steigerung
- Nur Tirzepatid: 73% Steigerung
- Nur Bremelanotid: 71% Steigerung
Bemerkenswert ist, dass niedrig dosiertes Bremelanotid wirksam war, um eine Gewichtszunahme nach Absetzen von Tirzepatid zu verhindern, während Patienten, die nur Tirzepatid erhielten, innerhalb von zwei Wochen nach Behandlungsende über 50 % des verlorenen Gewichts wieder zunahmen. Das Unternehmen plant, seine Pipeline für die nächste Generation von MC4R-Agonisten voranzutreiben, mit IND-Anmeldungen bis zum 4. Quartal 2025 und ersten klinischen Daten in der ersten Hälfte 2026.
- Bremelanotide matched or exceeded tirzepatide's appetite suppression efficacy
- Low-dose bremelanotide prevented weight regain after tirzepatide discontinuation
- All treatment arms showed significant improvements in appetite control metrics
- Pipeline expansion with next-generation MC4R agonists targeting broader obesity indications
- Over 50% weight regain within two weeks of stopping tirzepatide treatment
- Full study results still pending and not yet presented at medical conferences
Insights
Palatin's bremelanotide demonstrates significant appetite control matching GLP-1s with unique advantage preventing post-treatment weight rebound – major clinical breakthrough.
Palatin's Phase 2 study results represent a potential significant breakthrough in obesity management. The data shows bremelanotide, an MC4R agonist, achieved 71% improvement in appetite suppression as monotherapy, matching tirzepatide's efficacy. Most notably, patients transitioning to low-dose bremelanotide after tirzepatide discontinued maintained weight without regain, while the placebo group regained over 50% of lost weight within two weeks.
This addresses one of obesity treatment's most challenging aspects: post-treatment weight rebound. Current GLP-1/GIP therapies like tirzepatide work effectively during administration but often result in significant weight regain after discontinuation, making long-term obesity management difficult.
The melanocortin pathway represents a mechanistically distinct approach from incretin-based therapies. While GLP-1s primarily slow gastric emptying and affect peripheral hunger signals, MC4R agonists directly modulate hypothalamic appetite control centers – the body's central appetite regulation system. This explains why bremelanotide showed superior results in fullness (79% increase) and satiety (68% increase) compared to tirzepatide alone.
The co-administration approach could allow for lower doses of both agents, potentially reducing side effects while maintaining efficacy. However, the most promising clinical application appears to be using bremelanotide as maintenance therapy after initial GLP-1-induced weight loss, addressing the critical unmet need of preventing weight rebound.
Palatin's positive Phase 2 results for bremelanotide establish potential significant market position in obesity therapeutics with unique maintenance therapy advantage.
These Phase 2 results significantly strengthen Palatin's position in the rapidly expanding obesity treatment market, projected to reach $100+ billion by 2030. The data demonstrates bremelanotide's compelling dual potential: as either monotherapy matching tirzepatide's appetite suppression or as maintenance therapy preventing post-GLP-1 weight rebound.
What's particularly valuable is the demonstrated complementary mechanism to GLP-1s. While companies like Novo Nordisk and Eli Lilly dominate with incretin-based therapies, Palatin's melanocortin approach addresses a critical limitation – post-treatment weight maintenance. This positioning avoids direct competition with pharmaceutical giants while targeting a significant unmet need.
The most commercially viable path forward appears to be the maintenance therapy approach. This would require fewer resources for commercialization while providing substantial differentiation in a crowded market. The data showing prevention of weight rebound could make bremelanotide an essential companion therapy to GLP-1s.
For Palatin, with its micro-cap status (~$11.7M), these results significantly increase partnership potential. Large pharmaceutical companies with established GLP-1 franchises may view bremelanotide as a strategic acquisition to extend patent lifecycles and enhance their obesity portfolios. However, investors should note that commercialization remains distant, with next-generation compound IND filings expected only by Q4 2025, indicating substantial development work remains.
- Co-administered bremelanotide + tirzepatide, bremelanotide alone, and tirzepatide alone arms showed improvement in appetite suppression, fullness, and satiety
- Bremelanotide matched or exceeded tirzepatide in appetite suppression
- Low-dose bremelanotide helped prevent appetite rebound after tirzepatide cessation
"One of the important research questions that the study was designed to answer was whether a low- dose of an MC4R agonist could support long-term weight loss maintenance. We're excited with the results, which demonstrated that low-dose bremelanotide matched tirzepatide in appetite suppression, a compelling outcome," said Carl Spana, Ph.D., President and CEO of Palatin. "Just as importantly, low-dose bremelanotide significantly reduced the appetite rebound typically observed after stopping GLP-1/GIP therapy—one of the major hurdles in sustained obesity management."
Key Results – Appetite Suppression (Patient-Reported Outcomes)
Using a validated daily appetite questionnaire, the study showed that patients receiving co-administered bremelanotide + tirzepatide, tirzepatide alone, and bremelanotide alone, experienced significant improvements in appetite suppression, fullness, and satiety. Patients who transitioned to placebo after initial weight loss on tirzepatide showed no improvement for appetite suppression.
- Overall appetite suppression
- Bremelanotide + tirzepatide:
71% increase - Tirzepatide only:
73% increase - Bremelanotide only:
71% increase
- Bremelanotide + tirzepatide:
- "How full do you feel (fullness)?"
- Bremelanotide + tirzepatide:
65% increase - Tirzepatide only:
62% increase - Bremelanotide only:
79% increase
- Bremelanotide + tirzepatide:
- "How satisfied do you feel (satiety)?"
- Bremelanotide + tirzepatide:
56% increase - Tirzepatide only:
56% increase - Bremelanotide only:
68% increase
- Bremelanotide + tirzepatide:
Consistent with known effects of GLP-1/GIP therapy, over
Topline results from the BMT-801 Phase 2 trial, released last month, demonstrated statistically significant weight loss with bremelanotide co-administered with tirzepatide versus placebo over an 8-week treatment period. Further analysis of secondary and exploratory endpoints—including body composition and BMI—is ongoing.
Full study results will be submitted for presentation at an upcoming medical conference. Additional trial details are available at clinicaltrials.gov under identifier NCT06565611.
Pipeline Development
Palatin continues to advance its next-generation MC4R agonists, including long-acting peptides and oral small molecules, targeting broad obesity indications—including monotherapy and combination regimens with incretin-based therapies, as well as rare and genetic obesity disorders such as hypothalamic obesity. IND filings are anticipated by end of Q4 2025, with initial clinical data expected in the first half of 2026.
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 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.
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SOURCE Palatin Technologies, Inc.
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