The first participant has been dosed in MBX Biosciences’ Phase 1/2 clinical trial of MBX 1416, the company’s long-acting glucagon-like peptide 1 (GLP-1) receptor antagonist, being developed for the treatment of post-bariatric hypoglycemia (PBH).
MBX 1416 is an investigational long-acting glucagon-like peptide-1 (GLP-1) receptor antagonist in development as a potential first-in-class treatment for PBH. It was designed using the company’s novel, proprietary Precision Endocrine Peptide platform to prevent the occurrence of severe hypoglycemia in individuals with PBH so they can lead healthier and more independent lives.
The Phase 1/2 clinical trial is a randomised, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of MBX 1416 in healthy adult participants and patients with PBH. The trial is being conducted in the United States and is designed to enrol approximately 56 participants. The primary endpoint is safety and tolerability, and secondary endpoints include pharmacokinetics and pharmacodynamics.
“We are pleased to advance our second innovative PEP candidate, MBX 1416, into the clinic with the initiation of the Phase 1/2 clinical trial,” said Kent Hawryluk, President and Chief Executive Officer of MBX Biosciences. “This milestone is an important step toward bringing a potential solution to patients with PBH, for which there are no currently approved therapies. We look forward to continuing enrollment, with topline results anticipated in the second half of 2024.”