GLP-1/GIP receptor co-agonist designed to be highly potent and for once-monthly administration based on MBX’s novel PEP™ platform technology
Phase 1 trial of MBX 4291 is expected to initiate in Q3 2025
CARMEL, IN, USA I June 16, 2025 I MBX Biosciences, Inc. (Nasdaq: MBX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders, today 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 (GLP-1)/ glucose-dependent insulinotropic polypeptide (GIP) 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.”
About MBX 4291
MBX 4291 is an investigational long-acting GLP-1/GIP receptor co-agonist prodrug in development as a potential treatment for obesity. It was designed using the Company’s novel, proprietary PEP™ platform as a long-acting dual agonist with the potential for once-monthly dosing, improved gastrointestinal tolerability, and increased maximal weight loss.
In preclinical studies, the active component of MBX 4291 demonstrated a similar activity profile and body weight loss as tirzepatide, an approved weekly GLP-1/GIP co-agonist. In addition, extended duration of action of the active component of MBX 4291 was observed in additional preclinical studies compared to tirzepatide, supporting the potential for once-monthly administration.
About MBX Biosciences
MBX Biosciences is a biopharmaceutical company focused on the discovery and development of novel precision peptide therapies based on its proprietary PEP™ platform, for the treatment of endocrine and metabolic disorders. The Company is advancing a pipeline of novel candidates for endocrine and metabolic disorders with clinically validated targets, established endpoints for regulatory approval, significant unmet medical needs and large potential market opportunities. The Company’s pipeline includes its lead product candidate canvuparatide (MBX 2109), in Phase 2 development for the treatment of chronic hypoparathyroidism (HP); imapextide (MBX 1416), in Phase 1 development for the treatment of post-bariatric hypoglycemia (PBH); and an obesity portfolio that includes MBX 4291, with an IND currently under FDA review, as well as multiple discovery and pre-clinical candidates in development for the treatment of obesity. The Company is based in Carmel, Indiana. To learn more, please visit the Company website at www.mbxbio.com and follow it on LinkedIn.
About MBX’s Proprietary Precision Endocrine Peptide (PEP™) Platform
MBX was founded by global leaders with a transformative approach to peptide drug design and development. Leveraging this expertise, the Company designed its proprietary Precision Endocrine Peptide™ (PEP™) platform to overcome the key limitations of unmodified and modified peptide therapies and to improve clinical outcomes and simplify disease management for patients. PEPs are selectively engineered to have optimized pharmaceutical properties, including extended time-action profiles and consistent drug concentrations with low peak-to-trough concentration ratios, consistent exposure to target tissues, and less frequent dosing.
SOURCE: MBX Biosciences
Post Views: 1,694
GLP-1/GIP receptor co-agonist designed to be highly potent and for once-monthly administration based on MBX’s novel PEP™ platform technology
Phase 1 trial of MBX 4291 is expected to initiate in Q3 2025
CARMEL, IN, USA I June 16, 2025 I MBX Biosciences, Inc. (Nasdaq: MBX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders, today 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 (GLP-1)/ glucose-dependent insulinotropic polypeptide (GIP) 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.”
About MBX 4291
MBX 4291 is an investigational long-acting GLP-1/GIP receptor co-agonist prodrug in development as a potential treatment for obesity. It was designed using the Company’s novel, proprietary PEP™ platform as a long-acting dual agonist with the potential for once-monthly dosing, improved gastrointestinal tolerability, and increased maximal weight loss.
In preclinical studies, the active component of MBX 4291 demonstrated a similar activity profile and body weight loss as tirzepatide, an approved weekly GLP-1/GIP co-agonist. In addition, extended duration of action of the active component of MBX 4291 was observed in additional preclinical studies compared to tirzepatide, supporting the potential for once-monthly administration.
About MBX Biosciences
MBX Biosciences is a biopharmaceutical company focused on the discovery and development of novel precision peptide therapies based on its proprietary PEP™ platform, for the treatment of endocrine and metabolic disorders. The Company is advancing a pipeline of novel candidates for endocrine and metabolic disorders with clinically validated targets, established endpoints for regulatory approval, significant unmet medical needs and large potential market opportunities. The Company’s pipeline includes its lead product candidate canvuparatide (MBX 2109), in Phase 2 development for the treatment of chronic hypoparathyroidism (HP); imapextide (MBX 1416), in Phase 1 development for the treatment of post-bariatric hypoglycemia (PBH); and an obesity portfolio that includes MBX 4291, with an IND currently under FDA review, as well as multiple discovery and pre-clinical candidates in development for the treatment of obesity. The Company is based in Carmel, Indiana. To learn more, please visit the Company website at www.mbxbio.com and follow it on LinkedIn.
About MBX’s Proprietary Precision Endocrine Peptide (PEP™) Platform
MBX was founded by global leaders with a transformative approach to peptide drug design and development. Leveraging this expertise, the Company designed its proprietary Precision Endocrine Peptide™ (PEP™) platform to overcome the key limitations of unmodified and modified peptide therapies and to improve clinical outcomes and simplify disease management for patients. PEPs are selectively engineered to have optimized pharmaceutical properties, including extended time-action profiles and consistent drug concentrations with low peak-to-trough concentration ratios, consistent exposure to target tissues, and less frequent dosing.
SOURCE: MBX Biosciences
Post Views: 1,694
