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 designed to treat obesity. The company anticipates initiating a Phase 1 trial in Q3 2025, focusing on healthy overweight volunteers. This drug candidate leverages MBX’s proprietary PEP™ platform technology, aiming for once-monthly administration.
This IND submission marks a significant step for MBX Biosciences as it expands its pipeline addressing metabolic disorders. The obesity treatment market is substantial and growing, with a significant need for effective and tolerable therapies. A once-monthly treatment option like MBX 4291 could address key patient concerns around adherence and convenience, potentially improving outcomes and market differentiation. This development further establishes MBX Biosciences as a player in the evolving landscape of metabolic disease treatment.
Preclinical data suggest MBX 4291 exhibits a similar activity profile and weight loss effect as the currently approved weekly GLP-1/GIP co-agonist, tirzepatide. Notably, studies also indicate a potentially longer duration of action for MBX 4291, supporting the feasibility of once-monthly dosing. This could lead to improved patient compliance and potentially superior efficacy compared to existing weekly treatments. The company is also exploring additional early-stage obesity candidates using its PEP™ platform.
This IND submission for MBX 4291 positions the company for potential growth and market entry in the obesity treatment sector. The initiation of the Phase 1 trial in 2025 will be a critical milestone in evaluating the safety and efficacy of this promising new therapeutic candidate. Positive results could significantly impact the treatment landscape for obesity and further validate MBX Biosciences’ PEP™ platform technology.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
