Palatin Announces MC4R Agonist Bremelanotide Co-Administered with GLP-1/GIP Tirzepatide Meets Primary Endpoint in Phase 2 Obesity Study
Palatin Technologies (NYSE: PTN) announced positive results from its Phase 2 obesity study combining MC4R agonist bremelanotide with GLP-1/GIP tirzepatide. The 8-week treatment study met its primary endpoint with highly statistically significant results.
Key findings include:
- Co-administered group showed 4.4% weight reduction vs 1.6% for placebo (p<0.0001)
- 40% of co-administered patients achieved 5% weight reduction
- 27% reached 6% weight reduction
- 19% achieved 7% weight reduction
The study involved 113 patients, with 96 randomized across four treatment groups. Low-dose bremelanotide effectively stopped weight regain post-tirzepatide treatment. The company plans IND applications for next-generation MC4R long-acting peptides and oral small molecules in Q4 2025, with clinical data expected in 1H 2026.
Palatin Technologies (NYSE: PTN) ha annunciato risultati positivi dal suo studio di fase 2 sull'obesità che combina l'agonista MC4R bremelanotide con il GLP-1/GIP tirzepatide. Lo studio di trattamento di 8 settimane ha raggiunto il suo obiettivo primario con risultati altamente statisticamente significativi.
Le principali scoperte includono:
- Il gruppo co-somministrato ha mostrato una riduzione del peso del 4,4% rispetto all'1,6% per il placebo (p<0.0001)
- Il 40% dei pazienti co-somministrati ha raggiunto una riduzione del peso del 5%
- Il 27% ha raggiunto una riduzione del peso del 6%
- Il 19% ha ottenuto una riduzione del peso del 7%
Lo studio ha coinvolto 113 pazienti, di cui 96 randomizzati in quattro gruppi di trattamento. Il bremelanotide a bassa dose ha efficacemente fermato il recupero di peso dopo il trattamento con tirzepatide. L'azienda prevede di presentare domande IND per i peptidi a lunga durata d'azione MC4R di nuova generazione e piccole molecole orali nel quarto trimestre del 2025, con dati clinici attesi nel primo semestre del 2026.
Palatin Technologies (NYSE: PTN) anunció resultados positivos de su estudio de fase 2 sobre la obesidad que combina el agonista MC4R bremelanotide con el GLP-1/GIP tirzepatide. El estudio de tratamiento de 8 semanas cumplió su objetivo principal con resultados altamente estadísticamente significativos.
Los hallazgos clave incluyen:
- El grupo co-administrado mostró una reducción del peso del 4.4% frente al 1.6% del placebo (p<0.0001)
- El 40% de los pacientes co-administrados logró una reducción del peso del 5%
- El 27% alcanzó una reducción del peso del 6%
- El 19% logró una reducción del peso del 7%
El estudio involucró a 113 pacientes, de los cuales 96 fueron aleatorizados en cuatro grupos de tratamiento. El bremelanotide a baja dosis detuvo eficazmente la recuperación de peso después del tratamiento con tirzepatide. La empresa planea presentar solicitudes IND para péptidos de acción prolongada MC4R de próxima generación y pequeñas moléculas orales en el cuarto trimestre de 2025, con datos clínicos esperados en la primera mitad de 2026.
팔라틴 테크놀로지스 (NYSE: PTN)는 MC4R 작용제 브레멜라노타이드와 GLP-1/GIP 티르제파타이드를 결합한 2상 비만 연구의 긍정적인 결과를 발표했습니다. 8주 치료 연구는 통계적으로 매우 유의미한 결과로 주요 목표를 달성했습니다.
주요 발견 사항은 다음과 같습니다:
- 코-투여 그룹은 위약의 1.6%에 비해 4.4%의 체중 감소를 보였습니다 (p<0.0001)
- 코-투여 환자의 40%가 5% 체중 감소를 달성했습니다
- 27%가 6% 체중 감소를 달성했습니다
- 19%가 7% 체중 감소를 달성했습니다
이 연구에는 113명의 환자가 참여했으며, 그 중 96명이 네 개의 치료 그룹으로 무작위 배정되었습니다. 저용량 브레멜라노타이드는 티르제파타이드 치료 후 체중 회복을 효과적으로 멈췄습니다. 회사는 2025년 4분기에 차세대 MC4R 장기 작용 펩타이드 및 경구용 소분자에 대한 IND 신청을 계획하고 있으며, 2026년 상반기에 임상 데이터를 기대하고 있습니다.
Palatin Technologies (NYSE: PTN) a annoncé des résultats positifs de son étude de phase 2 sur l'obésité combinant l'agoniste MC4R bremelanotide avec le GLP-1/GIP tirzepatide. L'étude de traitement de 8 semaines a atteint son objectif principal avec des résultats hautement statistiquement significatifs.
Les principales conclusions incluent:
- Le groupe co-administré a montré une réduction de poids de 4,4 % contre 1,6 % pour le placebo (p<0,0001)
- 40 % des patients co-administrés ont atteint une réduction de poids de 5 %
- 27 % ont atteint une réduction de poids de 6 %
- 19 % ont atteint une réduction de poids de 7 %
L'étude a impliqué 113 patients, dont 96 ont été randomisés en quatre groupes de traitement. Le bremelanotide à faible dose a efficacement stoppé la reprise de poids après le traitement par tirzepatide. L'entreprise prévoit de soumettre des demandes IND pour des peptides MC4R à action prolongée de nouvelle génération et des petites molécules orales au quatrième trimestre 2025, avec des données cliniques attendues au premier semestre 2026.
Palatin Technologies (NYSE: PTN) hat positive Ergebnisse aus seiner Phase-2-Studie zur Adipositas bekannt gegeben, die den MC4R-Agonisten Bremelanotid mit GLP-1/GIP Tirzepatid kombiniert. Die 8-wöchige Behandlungsstudie erreichte ihr primäres Ziel mit hochgradig statistisch signifikanten Ergebnissen.
Wichtige Ergebnisse sind:
- Die co-administrierte Gruppe zeigte eine Gewichtsreduktion von 4,4% im Vergleich zu 1,6% für das Placebo (p<0.0001)
- 40% der co-administrierten Patienten erreichten eine Gewichtsreduktion von 5%
- 27% erreichten eine Gewichtsreduktion von 6%
- 19% erzielten eine Gewichtsreduktion von 7%
Die Studie umfasste 113 Patienten, von denen 96 in vier Behandlungsgruppen randomisiert wurden. Bremelanotid in niedriger Dosis stoppte effektiv die Gewichtszunahme nach der Behandlung mit Tirzepatid. Das Unternehmen plant IND-Anträge für die nächste Generation von lang wirkenden MC4R-Peptiden und oralen kleinen Molekülen im vierten Quartal 2025, mit klinischen Daten, die im ersten Halbjahr 2026 erwartet werden.
- Phase 2 obesity study met primary endpoint with highly significant results
- Co-administration showed superior weight loss (4.4%) compared to placebo (1.6%)
- Bremelanotide prevented weight regain after stopping tirzepatide
- No increased safety or tolerability concerns in combination therapy
- More than 50% of weight was regained within two weeks after treatment cessation
- Study used only low doses and was not designed to optimize weight loss
- Clinical data for next-generation treatments not expected until 1H 2026
Insights
Palatin's Phase 2 results represent a significant advancement in combinatorial obesity therapy. The co-administration of their MC4R agonist bremelanotide with tirzepatide achieved 4.4% weight reduction vs 1.6% for placebo (p<0.0001), demonstrating clear synergistic effects that exceeded statistical thresholds.
What's particularly noteworthy is that this study utilized low doses of both compounds and still achieved meaningful outcomes in just 8 weeks. The data showing that 40% of combination patients achieved ≥5% weight loss versus 27% on tirzepatide alone (p<0.05) indicates a substantive therapeutic benefit.
Perhaps most valuable is bremelanotide's ability to halt the rapid weight regain typically observed after GLP-1 discontinuation. This addresses a critical limitation of current obesity treatments and potentially opens new treatment paradigms for weight maintenance strategies.
While the sample size (96 randomized patients) is modest, the statistical significance achieved validates Palatin's approach. The company's pipeline of next-generation long-acting peptides and oral small molecules targeting MC4R represents a logical evolution of this platform, with INDs expected in Q4 2025.
The obesity market faces significant challenges with current GLP-1 therapies, including a 67% discontinuation rate due to side effects. Palatin's dual-mechanism approach could potentially improve tolerability profiles while enhancing efficacy, creating a substantial competitive advantage in this rapidly expanding therapeutic area.
These results demonstrate clear mechanistic synergy between MC4R and GLP-1/GIP pathways in obesity treatment. The statistically significant additive effects confirm what we've observed clinically—that targeting multiple pathways can overcome weight loss plateaus.
The most compelling finding is that 19% of co-administered patients achieved ≥7% weight loss versus 0% with tirzepatide alone. This suggests the combination pushes more patients into clinically meaningful weight reduction thresholds, even at low doses and short duration.
By targeting the hypothalamic melanocortin pathway, Palatin addresses a fundamental neurological driver of obesity that complements peripheral GLP-1 effects. The prevention of post-treatment weight regain is particularly promising—this represents an urgent unmet need in current obesity management paradigms.
Hypothalamic obesity represents a strategic opportunity with no approved treatments. By demonstrating efficacy in general obesity first, Palatin creates a pathway to address more specialized indications where current GLP-1s are less effective.
The company's focus on both long-acting peptides and oral small molecules provides multiple development paths. If their oral MC4R agonist PL7737 maintains efficacy while avoiding hyperpigmentation and hypertensive effects that have challenged previous MC4R candidates, it could substantially expand treatment options beyond injectable-only regimens that currently dominate the space.
- Primary endpoint met in the 8-week treatment study (highly statistically significant).
- Co-administered group had a
4.4% reduction in weight compared to1.6% for the placebo group (p<0.0001).
- Co-administered group had a
- Primary analysis for the co-administered group in the 8-week treatment study showed:
40% of patients achieved5% reduction in weight (p<0.05).27% achieved6% reduction in weight (p<0.05).19% achieved7% reduction in weight (p<0.1).
- Low dose bremelanotide arm stopped weight regain seen post tirzepatide treatment.
- Novel next-generation MC4R long-acting peptides and oral small molecules:
- IND applications planned for 4Q25; clinical data expected 1H26.
- Phase 1 SAD/MAD studies to include hypothalamic obesity patients.
- IND applications planned for 4Q25; clinical data expected 1H26.
"Although the study was not designed to optimize weight loss, this 8-week study utilizing low doses of both bremelanotide and tirzepatide, met the primary endpoint and was highly statistically significant," said Carl Spana, Ph.D., President & Chief Executive Officer of Palatin. "The positive results of this signal-generating study exceeded expectations. The data demonstrated that co-administration was additive and synergistic, resulting in increased weight loss, and that co-administration did not result in increased tolerability or safety issues for patients. The data also showed that low dose MC4R agonist bremelanotide stopped the rapid weight regain seen after ending GLP-1/GIP tirzepatide treatment."
Topline data results from the study were highly statistically significant for the study's primary endpoint, which was percent weight loss in patients for the co-administration of MC4R agonist bremelanotide plus GLP-1/GLP tirzepatide compared to placebo, over the 8-week treatment period.
- The co-administered group had a
4.4% reduction in weight compared to1.6% for the placebo group (p<0.0001).
The primary analysis for additive effect demonstrated that:
40% of patients in the co-administered group achieved a5% reduction in their body weight, compared to27% for the tirzepatide alone group (p<0.05).27% of patients in the co-administered group achieved a6% reduction in their body weight, compared to13% for the tirzepatide alone group (p<0.05).19% of patients in the co-administered group achieved a7% reduction in their body weight, compared to0% for the tirzepatide alone group (p<0.1).- Increase in the percent of subjects on co-administration achieving
5% ,6% and7% weight loss over tirzepatide alone, indicates that co-administration had a synergistic effect.
"This study provides compelling evidence that combining an MC4R agonist with a GLP-1/GIP compound creates a synergistic effect on weight loss," said Jesse Richards, DO, of Oklahoma State University College of Osteopathic Medicine. "These findings align with what we observe in our clinic, where we treat patients with severe genetic obesity using both mechanisms. With a critical need for diverse weight loss solutions, this approach offers a promising improvement to GLP-1/GIP monotherapy, particularly for those who struggle with tolerability at high doses."
In the study, patients first received a four-week treatment with tirzepatide alone (2.5 mg weekly) to confirm eligibility. They were then randomly assigned to one of four treatment groups for an additional four weeks: co-administration of MC4R bremelanotide (1.25 mg daily) and GLP-1/GIP tirzepatide (2.5 mg weekly), tirzepatide alone (2.5 mg weekly), bremelanotide alone (1.25 mg daily), or a placebo. A total of 113 patients were enrolled, with 96 randomized in a 3:1 ratio. Specifically, 46 patients were assigned to the MC4R plus GLP-1/GIP co-administration group, while the remaining arms had 15 to 16 patients each.
More than
Further data analysis is ongoing, including exploratory endpoints such as body composition and body mass index (BMI). The complete study results will be presented at an upcoming medical conference. Additional trial details can be accessed at https://clinicaltrials.gov using the identifier NCT06565611.
Palatin is advancing the development of its next-generation MC4R long-acting peptide and oral small molecule compounds for the treatment of general obesity, weight loss management, acquired and congenital hypothalamic obesity, and potentially, rare/orphan genetically caused MC4R pathway diseases. These therapies are being explored as stand-alone treatments, as well as in combination with GLP-1/GIP (incretin therapy), and as monotherapy for multiple genetic obesity disorders. Investigational New Drug (IND) applications are expected to be submitted in the fourth quarter of calendar 2025, with clinical data expected in the first half of calendar year 2026.
"We see hypothalamic obesity as a game-changing opportunity for Palatin, addressing a massive unmet medical need in a multi-billion-dollar market with no approved treatments," continued Dr. Spana. "Importantly, we are one of only two companies pioneering therapies that specifically target the MC4R pathway. Our highly selective, long-acting compounds—MC4R agonist peptides and the oral small molecule agonist PL7737—are designed to redefine treatment standards. Leveraging our deep expertise in MC4R agonist interactions, we have engineered these compounds to overcome critical challenges, including hyperpigmentation, hypertensive effects, the need for daily injections, and gastrointestinal side effects."
While GLP-1 receptor agonists are widely used to treat obesity, alternative treatments are necessary due to several drawbacks —
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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