MBX Biosciences’ positive topline data from the Phase I trial saw the drug being well tolerated with plans to move on to Phase II. Credit: Shutterstock / Poetra.RH

Indiana clinical-stage biopharmaceutical company, MBX Biosciences, has announced positive topline data from a Phase I trial of its glucagon-like peptide-1 receptor agonist (GLP-1RA) aimed at treating endocrine and metabolic disorders including post-bariatric hypoglycaemia (PBH).

The randomised, double-blind, placebo-controlled study (NCT06036784) enrolled healthy volunteers across two cohorts, a single ascending arm (SAD) group and multiple ascending dose (MAD) arm. Both arms met the primary endpoints of overall safety and tolerability, with no adverse events observed. In the MAD cohort, MBX 1416 median half-life was approximately 90 hours, which the company says would support weekly dosing of the drug.

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Now, the company says it is looking to parse its success into a Phase II study set to start in the second half of this year.

GLP-1RAs are typically more at home in the diabetes and weight loss spaces, but in recent years, the treatment has been trialled in several other indications. PBH is typically a complication of bariatric surgery that can result in low blood sugar levels.

Kent Hawryluk, president and chief executive officer of MBX Biosciences, said: “We are encouraged by the positive topline Phase I results in healthy volunteers that showed MBX 1416 was generally well-tolerated with a favourable safety profile and a promising pharmacokinetic profile supportive of once-weekly dosing.

“We also observed an apparent increase in GLP-1 peak during the first hour after a mixed meal tolerance test, which is an encouraging signal that we believe may translate into a therapeutic benefit in patients with PBH. Based on these results, we intend to initiate a Phase II study in patients with PBH in the second half of 2025 to further optimise dosing, pending alignment with the US Food and Drug Administration on our proposed study design.”

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Additionally, results from the trial found the drug-drug interaction (DDI) portion of the trial, found MBX 1416 had little impact on rosuvastatin exposure, a commonly prescribed statin for patients living with post-bariatric hypoglycaemia.

Elsewhere in the GLP1-RA space, New York obesity healthcare firm, Metsera has unveiled positive topline results from its Phase IIa trial of its GLP-1RA, MET-097i. Meanwhile, Novo Nordisk has taken a hit after its newest experimental weight loss drug, CagriSema, fell short of expectations.