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MBX Biosciences gains FDA clearance to study MBX 1416 for post-bariatric hypoglycaemia

MBX Biosciences, a clinical stage biopharmaceutical company developing Precision Endocrine Peptide (PEP) therapeutics to treat an array of endocrine disorders, has gained Investigational New Drug (IND) application for its MBX 1416, the company’s long-acting glucagon-like peptide 1 (GLP-1) receptor antagonist, being developed for the treatment of post-bariatric hypoglycaemia (PBH).

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 enrolment in a Phase 1 trial in the third quarter of 2023 and anticipates reporting topline results in the second half of 2024.

“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 hypoglycaemia and its associated symptoms and meaningfully improve patients’ lives. We look forward to initiating the Phase 1 trial later this quarter.”

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