MBX Biosciences, Inc. (Nasdaq: MBX) has announced the completion of the last subject's last visit in its Phase 1 single and multiple ascending dose trial of MBX 1416, a long-acting glucagon-like peptide 1 (GLP-1) receptor antagonist. The drug is under development for the treatment of post-bariatric hypoglycemia (PBH).
Kent Hawryluk, President and Chief Executive Officer of MBX Biosciences, expressed gratitude to the participants, investigators, and clinical team. He emphasized the significance of this milestone, bringing the company closer to providing a treatment option for PBH, a condition with no approved therapies.
Trial Design and Objectives
The Phase 1 clinical trial was a randomized, double-blind, placebo-controlled study conducted in the United States. It enrolled a total of 69 healthy adult participants to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of MBX 1416. The primary endpoint was safety and tolerability, while secondary endpoints included pharmacokinetics and pharmacodynamics. More details about the study can be found at www.clinicaltrials.gov, identifier NCT06036784.
About MBX 1416
MBX 1416 is an investigational long-acting GLP-1 receptor antagonist designed using MBX Biosciences’ proprietary PEP™ platform. It aims to prevent severe hypoglycemia in individuals with PBH, allowing them to lead healthier and more independent lives.
Post-Bariatric Hypoglycemia (PBH)
PBH is a rare but serious complication of bariatric surgery, characterized by repeated episodes of symptomatic hypoglycemia. These episodes are triggered by exaggerated secretion of GLP-1 levels following a meal and can occur as early as six months after Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy. Symptoms can include dizziness, confusion, loss of consciousness, or seizure. The unpredictability of these episodes can significantly hinder daily activities. Currently, there are no approved pharmacotherapies to treat PBH. As the use of surgery to address metabolic conditions continues to rise, the incidence of PBH is expected to increase, underscoring the need for effective therapies.
MBX Biosciences' Pipeline
MBX Biosciences is focused on developing novel precision peptide therapies for endocrine and metabolic disorders. Their pipeline includes MBX 2109, currently in Phase 2 development for chronic hypoparathyroidism (HP), and MBX 4291, part of an obesity portfolio, along with other preclinical candidates. The company is based in Carmel, Indiana.
