MBX Biosciences Doses First Participant in Phase 1/2 Clinical Trial for the Treatment of Post-Bariatric Hypoglycemia

MBX Biosciences, Inc. recently announced the first healthy adult participant has been dosed in its 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).

“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.”

The Phase 1/2 clinical trial is a randomized, 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 enroll approximately 56 participants. The primary endpoint is safety and tolerability, and secondary endpoints include pharmacokinetics and pharmacodynamics. More information on the Phase 1/2 study can be found at www.clinicaltrials.gov, identifier NCT06036784.

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 PEP platform to prevent the occurrence of severe hypoglycemia in individuals with PBH so they can lead healthier and more independent lives.

Post-bariatric hypoglycemia (PBH) is a rare and serious complication of bariatric surgery. PBH is characterized by repeated episodes of symptomatic hypoglycemia, triggered by excessive insulin levels following a meal, and can present as early as six months after Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy. Hypoglycemic episodes can occur multiple times per day and can periodically manifest with severe symptoms such as dizziness, confusion, loss of consciousness or seizure. The unpredictability of hypoglycemic episodes and their associated risks may meaningfully hinder daily activities. As a result, the patient burden can be substantial, and many individuals cannot drive, work or live alone. To date, 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, reinforcing the need for safe and effective therapies.

MBX Biosciences, Inc. is a clinical-stage biopharmaceutical company pioneering Precision Endocrine Peptide (PEP) therapeutic candidates to help people with endocrine disorders live fuller and healthier lives. MBX is advancing a pipeline of PEPs for clinically validated targets designed to deliver superior pharmaceutical properties and overcome key limitations of native peptide therapeutics. MBX’s pipeline includes its lead product candidate MBX 2109, completing Phase 1 development for the treatment of hypoparathyroidism, and MBX 1416, in Phase 1 development for the treatment of post-bariatric hypoglycemia. The company is supported by leading life science investors including Frazier Life Sciences, New Enterprise Associates, Norwest Venture Partners, OrbiMed, RA Capital Management and Wellington Management. MBX is based in Carmel, IN. For more information, visit www.mbxbio.com.