#Post-Bariatric-Hypoglycemia

2 stories

Clinical Trials May 11, 2026 · View digest

MBX Biosciences Obesity Portfolio Update: MBX 4291 Phase 1 Once-Monthly Profile, MBX 5765 Amycretin Prodrug Nominated, Imapextide Phase 2a STEADI Hits Proof of Concept in Post-Bariatric Hypoglycemia

MBX Biosciences (Nasdaq: MBX) released a May 11 obesity portfolio update covering three programs. MBX 4291, a GLP-1/GIP co-agonist prodrug, posted preliminary blinded Phase 1 MAD Part B data showing a T1/2Cmax1 of ~26 days, consistent with true once-monthly dosing; 12-week MAD Part C data expected Q4 2026. MBX 5765, a new amycretin prodrug combining GLP-1, GIP, glucagon, and DACRA (dual amylin and calcitonin receptor agonist) activity in a single construct, is in IND-enabling studies starting Q2 2026. Once-weekly imapextide hit proof of concept in the Phase 2a STEADI trial in post-bariatric hypoglycemia, with glucose nadir increased 17-34% across doses and insulin peak decreased 11-45% — directly competing with Amylyx's avexitide (Phase 3 LUCIDITY topline Q3 2026) for the same indication.

Clinical Trials May 10, 2026 · View digest

Amylyx Launches U.S. Expanded Access Program for Avexitide — First-in-Class Peptide GLP-1 Receptor Antagonist in Post-Bariatric Hypoglycemia

Amylyx Pharmaceuticals on May 5 launched a U.S. Expanded Access Program (EAP) for up to 250 adults with post-bariatric hypoglycemia (PBH) following Roux-en-Y gastric bypass surgery. The investigational compound, avexitide, is a first-in-class peptide GLP-1 *receptor antagonist* — designed to bind GLP-1 receptors on pancreatic islet beta cells and block the exaggerated GLP-1-driven insulin response characteristic of PBH, reducing inappropriate insulin secretion and stabilizing blood glucose. Avexitide carries FDA Breakthrough Therapy Designation for both PBH and congenital hyperinsulinism, plus Orphan Drug Designation. Topline data from the pivotal Phase 3 LUCIDITY trial are anticipated in Q3 2026. The program inverts the standard GLP-1 narrative — for this population, GLP-1 signaling is the problem.