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MBX Biosciences Announces U.S. FDA Clearance of IND Application for MBX 1416 for the Treatment of Post-Bariatric Hypoglycemia

Phase 1 trial initiation anticipated Q3 2023; Topline results expected in 2H 2024

CARMEL, Ind., August 7, 2023 — MBX Biosciences, Inc., a clinical stage biopharmaceutical company developing Precision Endocrine Peptide™ (PEP™) therapeutics to treat an array of endocrine disorders, today announced that the U.S. Food and Drug administration (FDA) has cleared the Investigational New Drug (IND) application for 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).

“IND clearance for MBX 1416 marks a significant milestone for our team, as we advance our second innovative PEP candidate into the clinic,” said Kent Hawryluk, President and Chief Executive Officer of MBX Biosciences. “As a potential first-in-class therapy for PBH, we believe MBX 1416 may prevent severe hypoglycemia and its associated symptoms and meaningfully improve patients’ lives. We look forward to initiating the Phase 1 trial later this quarter.”

MBX 1416 is an investigational long-acting GLP-1 receptor antagonist in development as a potential 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. MBX expects to initiate enrollment in a Phase 1 trial in the third quarter of 2023 and anticipates reporting topline results in the second half of 2024.

About Post-Bariatric Hypoglycemia

Post-bariatric hypoglycemia (PBH) is a rare disease and a serious complication of bariatric surgery. PBH is characterized by repeated episodes of symptomatic hypoglycemia, triggered by excessive insulin levels following a meal, and generally presents as early as six months after Roux-en-Y gastric bypass (RYGB). Hypoglycemic episodes can occur multiple times per day and can periodically manifest with severe symptoms such as dizziness, confusion, loss of consciousness or seizure due to glucose deficiency in the brain. 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. 

About MBX Biosciences

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, currently in Phase 1 development for the treatment of hypoparathyroidism (HP), and MBX 1416, entering Phase 1 development for the treatment of post-bariatric hypoglycemia (PBH). 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, Indiana. To learn more, please visit the company website at www.mbxbio.com and follow us on LinkedIn and Twitter.

Media Contact:
Ian Stone
Evoke Canale
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619-849-5388

Investor Contact:
Irina Koffler
LifeSci Advisors
[email protected]
917-734-7387