Latest news with #MC4R
Yahoo
10-07-2025
- Business
- Yahoo
Rhythm's stock climbs on encouraging Phase II obesity drug data
Rhythm Pharmaceuticals is advancing its oral obesity drug bivamelagon to Phase III studies after it significantly reduced body mass index (BMI) in all three doses. The Phase II study (NCT06046443) was investigating the therapy in patients with acquired hypothalamic obesity. Patients can also remain on the open-label extension of the study for 52 weeks. Topline data from the study has shown a 9.3% reduction in BMI in the high dose cohort (600mg), a 7.7% reduction in the medium dose cohort (400mg) and a 2.7% reduction in the low dose cohort (200mg) after 14 weeks. The placebo group saw a 2.2% increase in BMI. The BMI reduction achieved by bivamelagon, an investigational oral melanocortin-4 receptor (MC4R) agonist, was consistent with BMI reductions achieved with Rhythm's Imcivree (setmelanotide) therapy in similar patient populations in past trials. Patients in the high and medium dose cohorts achieved a mean reduction greater than 2.8 points in their 'most' hunger scores measured on a TEN-point scale. Patients in the low-dose arm achieved a mean reduction of 2.1 points, while patients on placebo therapy reported a mean increase of 0.8 points. The therapy also remained safe and tolerable in the study, consistent with other therapies in the MC4R agonism. On 9 July, Rhythm's stock, listed on the Nasdaq exchange, closed 36.63% higher at $89.00 compared to an 8 July close of $65.14. Rhythm Pharmaceuticals has a market cap of £5.66bn. Rhythm Pharmaceuticals' CEO Dr David Meeker said: 'We are excited by these results, which suggest bivamelagon has the potential to treat patients with acquired hypothalamic obesity, and has established an appropriate dose range for future clinical evaluation. Unlike in studies evaluating general obesity, once again we observed no placebo effect in this study.' Meeker said that Rhythm will be speaking with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the Phase III trial design of bivamelagon. Rhythm in-licensed bivamelagon from LG Chem in January 2024, with a $40m upfront payment and $20m in equity. Rhythm will also provide LG Chem with an additional $205m upon reaching certain regulatory and sales milestones. This is yet another positive readout for an oral obesity medicine. Last month, Novo Nordisk's amycretin, which is available in both subcutaneous and oral dosing, showed weight loss of up to 22% after 36 weeks, with the drug set to advance to Phase III. Furthest ahead in the game is Eli Lilly, with its oral glucagon-like peptide-1 receptor agonist (GLP-1RA) orforglipron having shown benefit in a Phase III trial. Lilly plans to submit the therapy for approval by the end of 2025, with a type 2 diabetes application to follow in 2026. GlobalData predicts the obesity market will continue to grow as new products are released, reaching $206.5bn in 2031. GlobalData is the parent company of Clinical Trials Arena. "Rhythm's stock climbs on encouraging Phase II obesity drug data" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
09-07-2025
- Business
- Yahoo
Rhythm Pharmaceuticals Announces Oral MC4R Agonist Bivamelagon Achieved Statistically Significant, Clinically Meaningful BMI Reductions in Placebo-controlled Phase 2 Trial in Acquired Hypothalamic Obesity
-- Bivamelagon achieved BMI reductions in patients with acquired hypothalamic obesity of -9.3% and -7.7% in 600mg and 400mg cohorts, respectively, at 14 weeks -- -- Post-hoc analysis showed BMI reductions in bivamelagon trial were consistent with BMI reductions achieved by setmelanotide in past trials in similar patient populations -- -- Patients in both 600mg and 400mg cohorts achieved mean reduction of -2.8 points in most hunger scores -- -- Limited instances of localized hyperpigmentation observed -- -- Rhythm to request End-of-Phase 2 meeting with U.S. FDA in order to pursue registrational path for bivamelagon in acquired hypothalamic obesity -- -- Company to host conference call today at 8 a.m. ET -- BOSTON, July 09, 2025 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced positive topline results from its Phase 2 trial evaluating bivamelagon (formerly LB54640), an investigational oral melanocortin-4 receptor (MC4R) agonist, in patients with acquired hypothalamic obesity. Bivamelagon achieved statistically significant and clinically meaningful reductions in body mass index (BMI) at 14 weeks of treatment, consistent with BMI reductions achieved with setmelanotide therapy in similar patient populations in past trials. Rhythm in-licensed bivamelagon from LG Chem, Ltd in January 2024. In the 14-week, double-blind, four-arm, placebo-controlled portion of the trial, bivamelagon achieved: -9.3% BMI reduction from baseline in the 600mg cohort (n=8) (p-value=0.0004); -7.7% BMI reduction from baseline in the 400mg cohort (n=7) (p-value=0.0002); -2.7% BMI reduction from baseline in the 200mg cohort (n=6) (p-value=0.0180); and BMI for patients in the placebo cohort (n=7) increased by 2.2% over 14 weeks. 'We are excited by these results, which suggest bivamelagon has the potential to treat patients with acquired hypothalamic obesity, and has established an appropriate dose range for future clinical evaluation. Unlike in studies evaluating general obesity, once again we observed no placebo effect in this study,' said David Meeker, M.D., Chair, Chief Executive Officer and President of Rhythm Pharmaceuticals. 'We look forward to engaging with U.S. and European regulatory authorities to seek alignment on a Phase 3 trial design as we continue advancing bivamelagon.' In a post-hoc analysis comparing the randomized Phase 2 results to results from prior setmelanotide trials, bivamelagon demonstrated BMI reductions consistent with BMI reductions achieved with setmelanotide therapy as observed in similar patient populations at comparable dosing durations. In this post-hoc comparison of the subset of setmelanotide patients who demonstrated study compliance and were not on concomitant GLP1 therapy (no patients who enrolled in the Phase 2 bivamelagon trial were on concomitant GLP1 therapy), setmelanotide and bivamelagon achieved: -9.7% and -10.5% mean BMI reductions achieved in a pooled patient population (n=59; n=64) from Phase 2 and Phase 3 trials of setmelanotide therapy at 12 weeks and 16 weeks, respectively; as compared to: -8.8% and -10.1% mean BMI reductions achieved in patients (400mg n=6; 600mg n=7) at 14 weeks of bivamelagon therapy. In addition, patients reported meaningful reductions in their 'most' hunger scores at 14 weeks on therapy compared to placebo, consistent with past setmelanotide trials and MC4R agonism. Patients in the 600mg (n=8) and 400mg (n=6) cohorts achieved a mean reduction greater than 2.8 points in their 'most' hunger scores measured on a 10-point scale at 14 weeks of bivamelagon therapy. Six patients in the 200mg arm achieved a mean reduction of 2.1 points in their 'most' hunger score, while patients on placebo therapy reported a mean increase of 0.8 points in their mean 'worst' hunger score. Bivamelagon demonstrated safety and tolerability results consistent with MC4R agonism and mechanism of action during the placebo-controlled portion of the trial. During the placebo-controlled portion of the trial, one patient discontinued therapy due to a serious adverse event (rectal bleeding). The most common reported adverse events were episodes of diarrhea and nausea, the vast majority of which were mild or grade 1. There were reports of mild, localized hyperpigmentation from four patients, including one patient on placebo. A total of 27 patients completed the 14-week, placebo-controlled portion of the trial, and 26 of them transitioned into the open-label extension of the trial and remained in that portion of the trial, as of July 7, 2025. Next Steps With these results in hand, Rhythm plans to seek input from U.S. and EU regulatory authorities on a Phase 3 trial design to advance bivamelagon in acquired hypothalamic obesity. The Company plans to request an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) and to seek scientific advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Rhythm also is refining the formulation of bivamelagon potentially to improve tolerability ahead of initiating a Phase 3 trial. As previously announced, Rhythm will present results from this trial in a poster accepted as a late-breaking abstract and data from Rhythm's pivotal Phase 3 TRANSCEND trial evaluating setmelanotide in both a live oral presentation and a poster at The Endocrine Society's Annual Meeting (ENDO 2025) on July 12, 2025 in San Francisco. About the Bivamelagon Phase 2 Trial The Phase 2 trial is a randomized, placebo-controlled, double-blind study to assess efficacy and safety of bivamelagon (formerly LB54640) on safety, weight reduction, hunger, and quality of life in patients 12 years of age and older (n=28) with acquired hypothalamic obesity. In the randomized portion of the trial, patients took an oral daily dose of either bivamelagon, low (200 mg), middle (400 mg), or high (600 mg), or placebo for 14 weeks. Patients may continue on therapy in the open-label portion for up to 52 weeks. Conference Call Information Rhythm Pharmaceuticals will host a live conference call and webcast at 8:00 a.m. ET today to discuss these clinical data. Participants may register for the conference call here. A webcast of the call will also be available under "Events and Presentations" in the Investor Relations section of the Rhythm Pharmaceuticals website at The archived webcast will be available on Rhythm Pharmaceuticals' website approximately two hours after the conference call and will be available for at least 30 days following the call. About Acquired Hypothalamic ObesityAcquired hypothalamic obesity is a rare form of obesity that occurs following damage to the hypothalamic region of the brain, which includes the melanocortin-4 receptor (MC4R) pathway and is responsible for controlling physiological functions such as hunger and weight regulation. Acquired hypothalamic obesity most frequently follows the growth or surgical removal of craniopharyngioma, astrocytoma or other rare brain tumors. Additional causes of injury may include traumatic brain injury, stroke, or inflammation due to infection. Patients experience accelerated weight gain, a reduction in energy expenditure, and hyperphagia (a chronic pathological condition characterized by insatiable hunger, impaired satiety, and persistent abnormal food-seeking behaviors) leading to severe obesity within six to 12 months following tumor resection or other injury. Rhythm estimates there are 5,000 to 10,000 people living with hypothalamic obesity in the U.S., 5,000 to 8,000 people living with hypothalamic obesity in Japan, and 3,500 to 10,000 people living with hypothalamic obesity in the E.U. About Rhythm Pharmaceuticals Rhythm is a commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. Rhythm's lead asset, IMCIVREE® (setmelanotide), an MC4R agonist designed to treat hyperphagia and severe obesity, is approved by the U.S. Food and Drug Administration (FDA) to reduce excess body weight and maintain weight reduction long term in adult and pediatric patients 2 years of age and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or genetically confirmed pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), deficiency or leptin receptor (LEPR) deficiency. Both the European Commission (EC) and the UK's Medicines & Healthcare Products Regulatory Agency (MHRA) have authorized setmelanotide for the treatment of obesity and the control of hunger associated with genetically confirmed BBS or genetically confirmed loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 2 years of age and above. Additionally, Rhythm is advancing a broad clinical development program for setmelanotide in other rare diseases, as well as investigational MC4R agonists bivamelagon and RM-718, and a preclinical suite of small molecules for the treatment of congenital hyperinsulinism. Rhythm's headquarters is in Boston, MA. Setmelanotide IndicationIn the United States, setmelanotide is indicated to reduce excess body weight and maintain weight reduction long term in adult and pediatric patients aged 2 years and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or Pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency as determined by an FDA-approved test demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS). In the European Union and the United Kingdom, setmelanotide is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed BBS or loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 2 years of age and above. In the European Union and the United Kingdom, setmelanotide should be prescribed and supervised by a physician with expertise in obesity with underlying genetic etiology. Limitations of Use Setmelanotide is not indicated for the treatment of patients with the following conditions as setmelanotide would not be expected to be effective: Obesity due to suspected POMC, PCSK1, or LEPR deficiency with POMC, PCSK1, or LEPR variants classified as benign or likely benign Other types of obesity not related to BBS or POMC, PCSK1, or LEPR deficiency, including obesity associated with other genetic syndromes and general (polygenic) obesity Contraindication Prior serious hypersensitivity to setmelanotide or any of the excipients in IMCIVREE. Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported. WARNINGS AND PRECAUTIONS Disturbance in Sexual Arousal: Spontaneous penile erections in males and sexual adverse reactions in females have occurred. Inform patients that these events may occur and instruct patients who have an erection lasting longer than 4 hours to seek emergency medical attention. Depression and Suicidal Ideation: Depression, suicidal ideation and depressed mood have occurred. Monitor patients for new onset or worsening depression or suicidal thoughts or behaviors. Consider discontinuing IMCIVREE if patients experience suicidal thoughts or behaviors, or clinically significant or persistent depression symptoms occur. Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported. If suspected, advise patients to promptly seek medical attention and discontinue IMCIVREE. Skin Hyperpigmentation, Darkening of Pre-existing Nevi, and Development of New Melanocytic Nevi: Generalized or focal increases in skin pigmentation, darkening of pre-existing nevi, development of new melanocytic nevi and increase in size of existing melanocytic nevi have occurred. Perform a full body skin examination prior to initiation and periodically during treatment to monitor pre-existing and new pigmented lesions. Risk of Serious Adverse Reactions Due to Benzyl Alcohol Preservative in Neonates and Low Birth Weight Infants: IMCIVREE is not approved for use in neonates or infants. Serious and fatal adverse reactions including 'gasping syndrome' can occur in neonates and low birth weight infants treated with benzyl alcohol preserved drugs. ADVERSE REACTIONS Most common adverse reactions (incidence ≥20%) included skin hyperpigmentation, injection site reactions, nausea, headache, diarrhea, abdominal pain, vomiting, depression, and spontaneous penile erection. USE IN SPECIFIC POPULATIONS Treatment with IMCIVREE is not recommended when breastfeeding. Discontinue IMCIVREE when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus. To report SUSPECTED ADVERSE REACTIONS, contact Rhythm Pharmaceuticals at +1 (833) 789-6337 or FDA at 1-800-FDA-1088 or See section 4.8 of the Summary of Product Characteristics for information on reporting suspected adverse reactions in Europe. Please see the full Prescribing Information for additional Important Safety Information. Forward-looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding our Phase 2 study to assess the efficacy and safety of bivamelagon in patients with acquired hypothalamic obesity and the potential for bivamelagon to treat hypothalamic obesity; the safety, efficacy, potential benefits of, and regulatory and clinical progress, potential regulatory submissions, approvals and timing thereof of bivamelagon, setmelanotide and other product candidates; the clinical design or progress of any of our products or product candidates at any dosage or in any indication; the potential benefits of any of the Company's products or product candidates for any specific disease indication or at any dosage, including the potential benefits of bivamelagon and setmelanotide for patients with acquired hypothalamic obesity or congenital hypothalamic obesity; our participation in upcoming events and presentations, and the date, time and content thereof and the timing of any of the foregoing. Statements using words such as 'expect', 'anticipate', 'believe', 'may', 'will' and similar terms are also forward-looking statements. Such statements are subject to numerous risks, uncertainties, including, but not limited to, our ability to enroll patients in clinical trials, the design and outcome of clinical trials, the impact of competition, the ability to achieve or obtain necessary regulatory approvals, risks associated with data analysis and reporting, our ability to successfully commercialize setmelanotide, our liquidity and expenses, our ability to retain our key employees and consultants, and to attract, retain and motivate qualified personnel, and general economic conditions, and the other important factors, including those discussed under the caption 'Risk Factors' in Rhythm's Quarterly Report on Form 10-Q for the three months ended March 31, 2025 and our other filings with the Securities and Exchange Commission. Except as required by law, we undertake no obligations to make any revisions to the forward-looking statements contained in this release or to update them to reflect events or circumstances occurring after the date of this release, whether as a result of new information, future developments or otherwise. Corporate Contact:David ConnollyHead of Investor Relations and Corporate CommunicationsRhythm Pharmaceuticals, Inc.857-264-4280dconnolly@ Media Contact:Sheryl SeapyReal Chemistry(949) 903-4750sseapy@ Sign in to access your portfolio
Yahoo
07-06-2025
- Business
- Yahoo
Jefferies Maintains Buy Rating on Rhythm Pharmaceuticals (RYTM), Sets $80 Price Target
In a report released on June 4, Dennis Ding from Jefferies maintained a Buy rating on Rhythm Pharmaceuticals, Inc. (NASDAQ:RYTM) with a price target of $80.00. The analyst based the rating on the company's strategic developments and promising pipeline. One of the primary reasons behind the rating was the anticipated Phase II data for the oral treatment for hypothalamic obesity (HO). It is expected to deliver notable BMI reduction and has been de-risked, thereby extending the potential of the franchise beyond the current expiration dates. A scientist conducting research in a laboratory, studying a Petri dish with advanced biopharmaceuticals. The analyst stated that management is confident in the weekly subcutaneous (subQ) treatment, which closely aligns with the previously approved setmelanotide, and thus further adds to the positive outlook for Rhythm Pharmaceuticals, Inc. (NASDAQ:RYTM). According to Ding, the setmelanotide Phase II open-label trial for Prader-Willi Syndrome can also pave the way for a significant opportunity if successful, even after its previous challenges. Management is focusing on patient starts instead of the immediate revenue post-launch, and this strategy supports the long-term growth prospects, according to the analyst. Rhythm Pharmaceuticals, Inc. (NASDAQ:RYTM) is a commercial-stage biopharmaceutical company that develops and commercializes therapeutics for the treatment of rare diseases. Its product pipeline includes IMCIVREE (setmelanotide), a precision medicine that treats hyperphagia and severe obesity caused by rare melanocortin-4 receptor (MC4R) diseases. The company also has other programs, including a preclinical suite of investigational candidates to treat congenital hyperinsulinism and a clinical development program for setmelanotide in other rare MC4R pathway diseases. While we acknowledge the potential of RYTM as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an extremely cheap AI stock that is also a major beneficiary of Trump tariffs and onshoring, see our free report on the best short-term AI stock. READ NEXT: and . Disclosure: None.
Yahoo
15-05-2025
- Health
- Yahoo
Axovia Therapeutics Unveils New Preclinical Data for AXV-201, for Treatment of Genetic Obesity Caused by MC4R Mutations, at ASGCT
Positive preclinical POC data show that novel gene therapy, AXV-201, prevented obesity and metabolic disease in a monogenic model LONDON, May 15, 2025 (GLOBE NEWSWIRE) -- Axovia Therapeutics Ltd., a biotechnology company developing therapies to address the genetic causes of blindness and obesity, announced that today it will unveil new preclinical proof-of-concept data for novelly designed, AXV-201, to treat individuals with severe obesity and very high BMIs resulting from MC4R mutations, in a poster presentation at the American Society of Gene and Cell Therapy (ASGCT) 28th Annual Meeting, which is being held from May 13-17, 2025 in New Orleans, LA. 'Today's presentation highlights how a new human sequence and AAV9 vector, AXV-201, can rescue the weight gain phenotype and could prove to be a powerful treatment for individuals with severe obesity and very high BMIs resulting from MC4R mutations,' said Dr. Victor Hernandez, Co-Founder and Chief Scientific Officer. 'MC4R is a key regulator of body weight and is the most common cause of genetic early-onset monogenic obesity. A gene replacement therapy could be transformative for those suffering across the globe.' Preclinical proof-of-concept data highlights include: New codon-optimized self-complementary human cMC4R sequence was able to express the MC4R transgene activity greater than five times more efficiently than the wild-type cDNA In vivo administration of AXV-201 in Mc4r-null mice prevented the development of obesity in males and females, restoring a normal weight trajectory comparable to wild-type controls and showed normalization of neurometabolic markers No safety concerns were observed when wild-types cohorts were dosed with AXV-201 'Genetic forms of obesity, such as those linked to MC4R mutations, represent a significant and often overlooked challenge for patients and clinicians alike,' said Dr. Jesse Richards, OU Health. 'Despite advances in obesity research, there remains a critical unmet need for effective therapies that address the underlying genetic causes. These data lay the groundwork for bringing new hope to individuals and families affected by MC4R-related obesity, offering the possibility of a targeted intervention that aims to normalize weight and have a better effect than currently available options.' About Melanocortin 4 Receptor () MutationsMelanocortin 4 receptor (MC4R) mutations are the most common cause of human monogenic obesity. Individuals with MC4R loss of function mutations suffer from hyperphagia, severe obesity and hyperinsulinemia. Impact of the different type of MC4R mutation depends on how they reduce MC4R expression and the impact they have on the production of cyclic AMP (cAMP). Mutations in heterozygosity, with partial MC4R functionality are the most frequent, but homozygous mutations and double heterozygotes account for 25% of MC4R mutations. There are approximately 50,000 patients with complete MC4R loss of function (LoF) and BMI>40 in the United States, European Union and Middle East. About Axovia Therapeutics Therapeutics is leading the development of therapies that address the genetic causes of blindness and obesity syndromes that are driven by cilia dysfunction. Ciliopathies are a group of more than 55 rare inherited genetic diseases linked to more than 950 genes that impact the function of cilia which are critical for protein transport and cellular signaling. The company plans to initiate a clinical study to treat retinal degeneration for its lead program for Bardet-Biedl Syndrome (BBS), AXV-101, in mid-2025, based on robust preclinical efficacy and toxicological data with established scaled GMP manufacturing and patient registries. AXV-101 has achieved U.S. Food and Drug Administration Orphan Drug Designation and Rare Pediatric Disease Designation. The company is developing its second program, AXV-201, for genetic obesity caused by MC4R mutations. Axovia is backed by ALSA Ventures and was formed following decades of work on ciliopathies at University College London by co-founders Professor Phil Beales and Dr. Victor Hernandez. For further information, please visit Contact:Professor Phil BealesChief Executive Officerinvestors@
Yahoo
17-04-2025
- Health
- Yahoo
Palatin Reports Positive Appetite Suppression Results From Phase 2 Obesity Study of MC4R Agonist Bremelanotide and Tirzepatide
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 CRANBURY, N.J., April 17, 2025 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, announced positive appetite suppression results from its BMT-801 Phase 2 obesity study. The study included a co-administered melanocortin 4 receptor (MC4R) agonist bremelanotide plus glucagon like peptide-1/gastric inhibitory polypeptide (GLP-1/GIP) tirzepatide arm, bremelanotide alone, and tirzepatide alone arms. "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 "How full do you feel (fullness)?" Bremelanotide + tirzepatide: 65% increase Tirzepatide only: 62% increase Bremelanotide only: 79% increase "How satisfied do you feel (satiety)?" Bremelanotide + tirzepatide: 56% increase Tirzepatide only: 56% increase Bremelanotide only: 68% increase Consistent with known effects of GLP-1/GIP therapy, over 50% of lost weight was regained within two weeks of stopping treatment in both the tirzepatide and co-administration arms of the study. In contrast, patients who transitioned to low-dose bremelanotide after initial weight loss on tirzepatide maintained their weight without any significant regain, underscoring the potential of MC4R agonists as a valuable therapy for long-term weight maintenance. 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 under identifier NCT06565611. Pipeline DevelopmentPalatin 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 ObesityGenetic 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 AgonistsThe 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 PalatinPalatin 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 and follow Palatin on Twitter at @PalatinTech. Forward-looking StatementsStatements 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. View original content to download multimedia: SOURCE Palatin Technologies, Inc. Sign in to access your portfolio
