imapextide (MBX 1416)
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MBX Biosciences Announces IND Submission of MBX 4291, its Long-acting GLP1/GIP Receptor Co-agonist Prodrug for the Treatment of Obesity
Globenewswire· 2025-06-16 12:00
Core Viewpoint - MBX Biosciences has submitted an Investigational New Drug (IND) application to the FDA for MBX 4291, a long-acting GLP-1/GIP receptor co-agonist prodrug aimed at treating obesity, with a Phase 1 trial expected to start in Q3 2025 [2][3][4] Company Overview - MBX Biosciences is a clinical-stage biopharmaceutical company focused on developing novel precision peptide therapies for endocrine and metabolic disorders [6] - The company is based in Carmel, Indiana, and is advancing a pipeline that includes multiple candidates for obesity and other metabolic disorders [6] Product Details - MBX 4291 is designed as a once-monthly injectable treatment for obesity, potentially offering improved gastrointestinal tolerability and better adherence compared to existing treatments [3][4] - Preclinical studies indicate that MBX 4291 has a similar activity profile and body weight loss effect as tirzepatide, an approved weekly GLP-1/GIP co-agonist, with an extended duration of action [5] Development Pipeline - The company is advancing several early-stage obesity candidates alongside MBX 4291, utilizing its proprietary PEP™ platform to create precision peptides with differentiating characteristics [3][6] - Other candidates in the pipeline include canvuparatide (MBX 2109) in Phase 2 for chronic hypoparathyroidism and imapextide (MBX 1416) in Phase 1 for post-bariatric hypoglycemia [6] Proprietary Technology - MBX's PEP™ platform is designed to enhance peptide drug design, aiming to overcome limitations of traditional peptide therapies by optimizing pharmaceutical properties such as extended action profiles and consistent drug concentrations [7]