Tirzepatide

GLP-1/GIP receptor co-agonist designed to be highly potent and for once-monthly administration based on MBX’s novel PEP™ platform technology Phase 1 trial of MBX 4291 is expected to initiate in Q3 2025 CARMEL, IN, USA I June 16, 2025 I MBX Biosciences, Inc. (Nasdaq: MBX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders, today announced submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for MBX 4291, a long-acting glucagon-like peptide-1 (GLP-1)/ glucose-dependent insulinotropic polypeptide (GIP) receptor co-agonist prodrug for the treatment of obesity. “MBX 4291 is designed to be a potential best-in-class, once-monthly injectable for the treatment of obesity,” said Kent Hawryluk, President and Chief Executive Officer of MBX Biosciences. “We believe MBX 4291 could potentially offer less frequent dosing and improved gastrointestinal tolerability, which may result in better adherence and increased maximal weight loss. Following IND clearance, we plan to initiate a Phase 1 trial evaluating MBX 4291 in healthy overweight volunteers in the third quarter of 2025. We are also advancing multiple early-stage obesity candidates using our proprietary platform to build precision peptides with differentiating characteristics.” About MBX 4291 MBX 4291 is an investigational long-acting GLP-1/GIP receptor co-agonist prodrug in development as a potential treatment for obesity. It was designed using the Company’s novel, proprietary PEP™ platform as a long-acting dual agonist with the potential for once-monthly dosing, improved gastrointestinal tolerability, and increased maximal weight loss. In preclinical studies, the active component of MBX 4291 demonstrated a similar activity profile and body weight loss as tirzepatide, an approved weekly GLP-1/GIP co-agonist. In addition, extended duration of action of the active component of MBX 4291 was observed in additional preclinical studies compared to tirzepatide, supporting the potential for once-monthly administration. About MBX Biosciences MBX Biosciences is a biopharmaceutical company focused on the discovery and development of novel precision peptide therapies based on its proprietary PEP™ platform, for the treatment of endocrine and metabolic disorders. The Company is advancing a pipeline of novel candidates for endocrine and metabolic disorders with clinically validated targets, established endpoints for regulatory approval, significant unmet medical needs and large potential market opportunities. The Company’s pipeline includes its lead product candidate canvuparatide (MBX 2109), in Phase 2 development for the treatment of chronic hypoparathyroidism (HP); imapextide (MBX 1416), in Phase 1 development for the treatment of post-bariatric hypoglycemia (PBH); and an obesity portfolio that includes MBX 4291, with an IND currently under FDA review, as well as multiple discovery and pre-clinical candidates in development for the treatment of obesity. The Company is based in Carmel, Indiana. To learn more, please visit the Company website at www.mbxbio.com and follow it on LinkedIn. About MBX’s Proprietary Precision Endocrine Peptide (PEP™) Platform MBX was founded by global leaders with a transformative approach to peptide drug design and development. Leveraging this expertise, the Company designed its proprietary Precision Endocrine Peptide™ (PEP™) platform to overcome the key limitations of unmodified and modified peptide therapies and to improve clinical outcomes and simplify disease management for patients. PEPs are selectively engineered to have optimized pharmaceutical properties, including extended time-action profiles and consistent drug concentrations with low peak-to-trough concentration ratios, consistent exposure to target tissues, and less frequent dosing. SOURCE: MBX Biosciences

Hormonal and neural regulatory mechanisms that maintain blood glucose levels within a very narrow range Science is fun. Science is curiosity. We all have natural curiosity. Science is a process of investigating. It's posing questions and coming up with a method. It's delving in.” — Sally Ride ALISO VIEJO, CA, UNITED STATES, June 16, 2025 / EINPresswire.com / -- Glucose from a diet is the major energy source for humans and other mammals. Blood glucose concentrations increase rapidly after food intake and then decline as glucose is used or stored. Since nutrient intake is irregular but energy requirement is continuous, the body needs to store glucose, usually as glycogen, mainly in the muscles and liver. Two peptides produced by the pancreas, insulin and glucagon, control glucose storage by enhancing glucose uptake and glycogen breakdown, respectively. Persistent high blood glucose concentrations result from diminished insulin production as in type 1 diabetes or insulin resistance, a decreased cellular response to insulin as in type 2 diabetes . Type 2 diabetes is a chronic disease defined by hyperglycemia leading to microvascular and macrovascular damage. The prevalence of diabetes has been increasing globally since 1990, attributed to living environments and lifestyle leading to poorer nutrition and increased sedentary behaviour. The International Diabetes Federation estimates that 11.1% of the world’s adult population aged 20-79 years, around 452 million people, is living with diabetes, with 4 in 10 of these people unaware that they have the disease. Diabetes is more prevalent in people aged 65 years and older, including 122 million of this population of 652 million, or around 19%; further, prediabetes affects 48% of the 26 million older adults in the USA. The risk to these patients is increased by multiple comorbidities, increased incidence of hypoglycemia, increased dependence on care and worsening frailty. Cardiovascular disease remains the leading cause of death in type 2 diabetics, even though a marked decrease in all-cause mortality of 30–35% in diabetics in the USA and England has been related to decreases in mortality from cardiovascular disease. Cancer rates have remained unchanged in diabetes patients, but this is now an increased percentage of deaths while mortality rates from dementia and liver disease have increased. Lifestyle modifications, including nutrition and exercise, are the foundation for the management of type 2 diabetes. Drug treatment of diabetes now includes metformin, which lowers liver production of glucose, sulphonylureas such as glyburide, which stimulate insulin production, thiazolidinediones such as pioglitazone which increase glucose uptake into tissues, prompting insulin secretion and decreasing appetite with glucagon-like peptide-1 receptor agonists, including semiglutide, combined glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonists such as tirzepatide and preventing the reabsorption of glucose in the kidneys by sodium-glucose cotransporter-2 inhibitors such as dapagliflozin and empagliflozin. Research is continuing, so potential clinical use of adiponectin and fibroblast growth factor 21 could allow personalized approaches to lower blood glucose concentrations. Healthy eating plans are essential for long-term control of diabetes. Preclinical trials with anthocyanin-containing foods have shown regulation of blood glucose concentrations, improved gut microbiota, reduced insulin resistance and inflammation, and changed adipocyte function. Large prospective cohort trials in people in the USA have shown an inverse relationship between a healthy plant-based diet and the risk of developing diabetes. Dietary anthocyanin intake was linked to a 15% lower incidence of type 2 diabetes in 8 cohort studies involving 394,913 participants. In a summary of 18 human trials in type 2 diabetes from the last 5 years, anthocyanins reduced blood glucose and HbA1c concentrations and improved insulin secretion and resistance, especially in at-risk groups. Further, diets containing polyphenols such as anthocyanins may reduce the risk of developing diabetes. The incidence of type 2 diabetes decreased by 5% when the intake of anthocyanins increased by 7.5 mg/day. As examples, plums such as the Queen Garnet, Illawarra and Davidson’s varieties may contain 250-500 mg anthocyanins per 100g fruit. Other important dietary sources of anthocyanins include raspberries, bilberries, chokeberries, mulberries, and saskatoon berries. These clinical investigations support the preclinical studies that anthocyanins simultaneously affect many targets associated with type 2 diabetes. These studies reinforce that improving nutritional status in people with diabetes by adding anthocyanin-containing fruit to current treatment regimens is likely to improve clinical outcomes. Nutrition, exercise, and treatment with antidiabetic medications remain the key approaches to the treatment of type 2 diabetes. Todd D. Sonoga GenBio Inc. +1 949-705-8021 email us here Visit us on social media: LinkedIn Facebook X GenBio Inc Elevator Pitch Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. 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