MBX Biosciences

The company is a clinical-stage biopharmaceutical organization focused on developing novel precision peptide therapies for the treatment of endocrine and metabolic diseases. (Incorporated in Delaware)

The leading drug candidate, MBX 2109, is a parathyroid hormone peptide intended as a potential long-acting hormone replacement therapy for chronic hypoparathyroidism. The company was founded by global leaders in peptide drug design and development, and through this expertise, developed a proprietary Precision Endocrine Peptide™ (PEPTM) platform. This platform addresses the limitations of unmodified and modified peptide therapies to enhance clinical outcomes and simplify disease management for patients. The PEPs are selectively engineered for optimized pharmaceutical properties, such as extended time-action profiles, consistent drug concentrations with low peak-to-trough ratios, stable exposure to target tissues, and reduced dosing frequency.

The company is advancing a pipeline of novel candidates targeting endocrine and metabolic disorders, focusing on clinically validated targets, established regulatory endpoints, significant unmet medical needs, and large potential market opportunities.

The product candidates and programs include:

• MBX 2109: The lead product candidate, MBX 2109, is a parathyroid hormone peptide prodrug designed as a long-acting hormone replacement therapy for chronic hypoparathyroidism (HP). Using the PEP platform, MBX 2109 aims to address the underlying pathophysiology of HP by providing continuous, infusion-like exposure to parathyroid hormone (PTH) with convenient once-weekly administration. In a Phase 1 clinical trial, MBX 2109 demonstrated a low peak-to-trough ratio and an extended half-life, supporting the possibility of once-weekly PTH dosing for HP patients. The drug was well-tolerated, with no severe or serious adverse effects related to the drug. Currently, MBX 2109 is under evaluation in a Phase 2 clinical trial, with the first patient dosed in August 2024. Topline data from this trial is anticipated in the third quarter of 2025.

• MBX 1416: MBX 1416, a long-acting glucagon-like peptide-1 (GLP-1) receptor antagonist, is being developed as a potential therapy for post-bariatric hypoglycemia (PBH), a chronic complication of bariatric surgery. MBX 1416 is designed for once-weekly administration to reduce insulin secretion and raise blood glucose levels, thereby mitigating the frequency and severity of hypoglycemic episodes. Preliminary pharmacokinetic data from the ongoing Phase 1 clinical trial showed dose-proportional increases in MBX 1416 exposure and a half-life that supports once-weekly dosing. Additional data from the single ascending dose and multiple ascending dose portions of the trial are expected in the fourth quarter of 2024.

• Obesity portfolio: The lead obesity product candidate, MBX 4291, is designed as a long-acting, highly potent GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) receptor co-agonist prodrug. This candidate aims to reduce dosing frequency and improve efficacy and tolerability compared to current standards of care.