MBX Biosciences, Inc.

The company is a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing precision peptide therapies for endocrine and metabolic disorders. It was founded by global leaders with an approach to peptide drug design and development. The company designed its proprietary Precision Endocrine Peptide ("PEP") platform to address limitations of unmodified and modified peptide therapies, aiming to improve clinical outcomes and simplify disease management. PEPs are engineered for optimized pharmaceutical properties, including extended time-action profiles, consistent drug concentrations with low peak-to-trough concentration ratios, consistent exposure to target tissues, and less frequent dosing. The company is developing a pipeline of candidates for endocrine and metabolic disorders with clinically validated targets and established endpoints for regulatory approval. Its lead product candidate is Canvuparatide (MBX 2109), a parathyroid hormone ("PTH") peptide prodrug. Canvuparatide is designed as a potential long-acting hormone replacement therapy for chronic hypoparathyroidism ("HP"), aiming to provide continuous, infusion-like exposure to PTH with once-weekly administration. In a Phase 1 clinical trial, canvuparatide showed a low peak-to-trough ratio and an extended half-life, potentially enabling the first once-weekly PTH dosing regimen for HP patients. It was generally well-tolerated with no drug-related severe or serious adverse effects. In a Phase 2 clinical trial of 64 patients with HP, canvuparatide met the primary endpoint with a statistically significant responder rate at Week 12 and showed positive six-month responder results from the open-label extension. All patients completed the 12-week trial, and canvuparatide was generally well-tolerated, with no treatment-related serious adverse events or discontinuations.