Palatin Announces Positive Preclinical Efficacy Data for Oral MC4R Agonist PL7737 in Animal Model of Obesity
Palatin Technologies (OTCQB: PTNT) announced promising preclinical results for PL7737, their oral melanocortin-4 receptor (MC4R) agonist for obesity treatment. The study demonstrated significant weight loss in diet-induced obese rats, with the high dose achieving 10% weight loss as monotherapy and 15% weight loss in combination with tirzepatide after just 4 days.
The company plans to submit an IND in Q4 2025 and expects clinical data in 1H 2026. PL7737 received FDA orphan drug designation for leptin receptor deficiency-related obesity. Palatin is developing both oral and subcutaneous MC4R agonists, positioning itself in the competitive obesity treatment market with a unique mechanism of action compared to incretin-based therapies.
Palatin Technologies (OTCQB: PTNT) ha annunciato risultati preclinici promettenti per PL7737, il loro agonista orale del recettore melanocortina-4 (MC4R) per il trattamento dell'obesit脿. Lo studio ha mostrato una significativa perdita di peso in ratti obesi indotti da dieta, con la dose elevata che ha raggiunto una perdita del 10% come monoterapia e una perdita del 15% in combinazione con tirzepatide dopo soli 4 giorni.
L'azienda prevede di presentare una IND nel quarto trimestre 2025 e si aspetta dati clinici nella prima met脿 del 2026. PL7737 ha ricevuto la designazione di farmaco orfano dalla FDA per l'obesit脿 correlata a carenza del recettore della leptina. Palatin sta sviluppando agonisti MC4R sia orali che sottocutanei, posizionandosi nel competitivo mercato dei trattamenti per l'obesit脿 con un meccanismo d'azione unico rispetto alle terapie basate sugli incretini.
Palatin Technologies (OTCQB: PTNT) anunci贸 resultados precl铆nicos prometedores para PL7737, su agonista oral del receptor melanocortina-4 (MC4R) para el tratamiento de la obesidad. El estudio demostr贸 una p茅rdida de peso significativa en ratas obesas inducidas por dieta, con la dosis alta logrando una p茅rdida del 10% como monoterapia y una p茅rdida del 15% en combinaci贸n con tirzepatida tras solo 4 d铆as.
La compa帽铆a planea presentar una IND en el cuarto trimestre de 2025 y espera datos cl铆nicos en el primer semestre de 2026. PL7737 recibi贸 la designaci贸n de medicamento hu茅rfano por parte de la FDA para la obesidad relacionada con deficiencia del receptor de leptina. Palatin est谩 desarrollando agonistas MC4R orales y subcut谩neos, posicion谩ndose en el competitivo mercado de tratamientos para la obesidad con un mecanismo de acci贸n 煤nico en comparaci贸n con las terapias basadas en incretinas.
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Palatin Technologies (OTCQB : PTNT) a annonc茅 des r茅sultats pr茅cliniques prometteurs pour PL7737, leur agoniste oral du r茅cepteur m茅lanocortine-4 (MC4R) destin茅 au traitement de l鈥檕b茅sit茅. L鈥櫭﹖ude a montr茅 une perte de poids significative chez des rats ob猫ses induits par un r茅gime alimentaire, avec une perte de poids de 10 % 脿 forte dose en monoth茅rapie et une perte de 15 % en association avec la tirz茅patide apr猫s seulement 4 jours.
L鈥檈ntreprise pr茅voit de soumettre une demande d鈥橧ND au 4e trimestre 2025 et attend des donn茅es cliniques au premier semestre 2026. PL7737 a re莽u la d茅signation de m茅dicament orphelin par la FDA pour l鈥檕b茅sit茅 li茅e 脿 une d茅ficience du r茅cepteur de la leptine. Palatin d茅veloppe des agonistes MC4R oraux et sous-cutan茅s, se positionnant ainsi sur le march茅 concurrentiel des traitements de l鈥檕b茅sit茅 avec un m茅canisme d鈥檃ction unique par rapport aux th茅rapies bas茅es sur les incr茅tines.
Palatin Technologies (OTCQB: PTNT) gab vielversprechende pr盲klinische Ergebnisse f眉r PL7737 bekannt, ihren oralen Melanocortin-4-Rezeptor (MC4R) Agonisten zur Behandlung von Fettleibigkeit. Die Studie zeigte eine signifikante Gewichtsabnahme bei di盲tinduzierten adip枚sen Ratten, wobei die hohe Dosis als Monotherapie eine Gewichtsreduktion von 10% und in Kombination mit Tirzepatid eine Gewichtsreduktion von 15% nach nur 4 Tagen erreichte.
Das Unternehmen plant die Einreichung eines IND im 4. Quartal 2025 und erwartet klinische Daten im ersten Halbjahr 2026. PL7737 erhielt von der FDA die Orphan-Drug-Designation f眉r Adipositas, die mit einem Leptinrezeptormangel zusammenh盲ngt. Palatin entwickelt sowohl orale als auch subkutane MC4R-Agonisten und positioniert sich mit einem einzigartigen Wirkmechanismus im wettbewerbsintensiven Markt f眉r Adipositasbehandlungen, der sich von inkretinbasierten Therapien unterscheidet.
- None.
- Clinical trials haven't started yet - IND submission planned for Q4 2025
- Results limited to preclinical animal studies - human efficacy yet to be demonstrated
- Potential competition from established obesity treatments in the market
- Oral PL7737 monotherapy produced rapid and significant weight loss after just 4 days of treatment
- Combination of oral PL7737 and tirzepatide resulted in additive weight loss effects
- IND-enabling toxicology program ongoing
- IND submission planned for 4Q2025; Clinical data expected in 1H2026
The preclinical study evaluated the weight loss effects of three oral doses of PL7737, both alone and in combination with tirzepatide (a GLP-1/GIP agonist), in a diet-induced obese (DIO) rat model. After 4 days of treatment, all results were statistically significant compared to vehicle control:
- PL7737 鈥� Middle Dose:
5% weight loss - PL7737 鈥� High Dose:
10% weight loss - Tirzepatide Alone:
5% weight loss - PL7737 Middle Dose + Tirzepatide:
11% weight loss - PL7737 High Dose + Tirzepatide:
15% weight loss
"The rapid and significant weight loss seen with oral PL7737, both as monotherapy and in combination with tirzepatide in this established animal model, is impressive and suggests the potential for meaningful weight reduction in humans," said Carl Spana, Ph.D., President and CEO of Palatin. "We are also evaluating PL7737 as a treatment for hypothalamic obesity and plan to begin a Phase 1 single- and multiple-ascending dose (SAD/MAD) clinical trial in late 2025, with data expected in the first half of 2026."
Dr. Spana continued, "Palatin is developing a strong pipeline of novel MC4R agonists to treat obesity. Unlike incretin-based therapies, MC4R agonists offer a unique mechanism of action. In addition to oral PL7737, we have developed several selective peptide MC4R agonists designed for weekly subcutaneous administration, with no observed hyperpigmentation. Our deep expertise in melanocortin research allows us to efficiently advance both oral PL7737 and a long-acting peptide candidate, providing flexibility to target both general obesity and rare forms of the disease. We expect Phase 1 data for both programs in the first half of 2026."
Earlier this year, Palatin reported positive Phase 2 results from a study evaluating the combination of bremelanotide (an MC4R agonist) and tirzepatide (a GLP-1/GIP agonist). The study met its primary endpoint over the 8-week treatment period with highly statistically significant results. Additionally, Palatin announced that the FDA granted orphan drug designation to PL7737 for the treatment of leptin receptor (LEPR) deficiency-related obesity, a rare genetic disorder that disrupts MC4R signaling due to mutations in the LEPR gene. The leptin-melanocortin pathway, located in the hypothalamus, regulates hunger, energy balance, and body weight. Individuals with LEPR deficiency often experience constant, intense hunger from a young age, leading to severe early-onset obesity. PL7737, an MC4R agonist, is designed to restore this disrupted signaling.
Melanocortin-4 Receptor Agonists Effect on Obesity
Hypothalamic neurons expressing the melanocortin-4 receptor (MC4R) play a central role in regulating stored energy, food intake, and body weight. Genetic mutations that inhibit signaling through 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. MC4R agonism represents an attractive target for potential obesity treatments.
About Hypothalamic Obesity
Hypothalamic obesity is a rare and severe form of obesity caused by dysfunction or damage to the hypothalamus, the region of the brain that regulates appetite, satiety, and energy balance. Hypothalamic obesity can occur as an acquired condition, most commonly after surgery or radiation therapy for brain tumors such as craniopharyngioma, or as a congenital disorder associated with genetic syndromes and developmental abnormalities affecting hypothalamic function. Individuals with hypothalamic obesity typically experience rapid, excessive weight gain, uncontrollable hunger, and profound metabolic disturbances that are resistant to conventional diet, exercise, and behavioral interventions. There are currently no approved pharmacologic treatments specifically indicated for hypothalamic obesity, representing a significant unmet medical need.
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 聽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庐 is a registered trademark of Palatin Technologies, Inc.
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