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MBX Biosciences Receives FDA Clearance for IND Application of MBX 1416 to Address Post-Bariatric Hypoglycemia

Tuesday, August 08, 2023

MBX Biosciences, a biopharmaceutical company in the clinical stage, dedicated to developing Precision Endocrine Peptide™ (PEP™) therapeutics for a range of endocrine disorders, has obtained FDA clearance for its Investigational New Drug (IND) application for MBX 1416. This novel drug is a long-acting antagonist of the glucagon-like peptide 1 (GLP-1) receptor and is being designed to address post-bariatric hypoglycemia (PBH).

Kent Hawryluk, the CEO of MBX Biosciences, emphasized the significance of this achievement, as it marks the advancement of their second innovative PEP candidate into clinical trials. The potential of MBX 1416 as a groundbreaking treatment for PBH is grounded in its capacity to avert severe hypoglycemia and its accompanying symptoms, thereby enhancing the quality of life for patients. The Phase 1 trial is set to commence later in the current quarter.

MBX 1416, an investigational GLP-1 receptor antagonist with extended activity, has been meticulously engineered using the company's distinctive PEP platform. The intention is to preclude occurrences of severe hypoglycemia among PBH patients, promoting overall health and self-sufficiency. Anticipated to begin enrolling participants in the third quarter of 2023, the Phase 1 trial's top-line results are projected to be disclosed in the latter half of 2024.

Post-bariatric hypoglycemia (PBH) is an infrequent yet serious aftermath of bariatric surgery. It is distinguished by recurrent episodes of symptomatic hypoglycemia, usually set off by elevated insulin levels following meals, often emerging about six months post Roux-en-Y gastric bypass (RYGB) surgery. These episodes of hypoglycemia can manifest multiple times a day and intermittently lead to severe symptoms such as dizziness, confusion, loss of consciousness, or even seizures due to insufficient glucose supply to the brain. The erratic nature of these episodes and the associated risks can substantially impede daily activities. As a result, patients face considerable challenges, including limitations on driving, working, or living independently. At present, no approved pharmacotherapies exist for PBH. Given the increasing reliance on surgery for managing metabolic conditions, the prevalence of PBH is projected to rise, underlining the pressing need for safe and effective treatment approaches.

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