MBX Biosciences announces IND application to FDA for MBX 4291

MBX Biosciences (MBX) 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/ glucose-dependent insulinotropic polypeptide 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.”