On Tuesday, MBX Biosciences Inc ( MBX ). revealed results from its Phase 1 single ascending dose and multiple ascending dose trial of MBX 1416 in healthy adult volunteers.

MBX 1416 is the company’s investigational long-acting glucagon-like peptide 1 (GLP-1) receptor antagonist, being developed for Post-Bariatric Hypoglycemia (PBH).

PBH is a common and potentially serious complication that can occur after certain types of weight loss surgery.

Trial data:

MBX 1416 was generally well-tolerated with a favorable safety profile.

No MBX 1416 dose-related serious adverse events were observed, and most treatment-emergent adverse events were mild or moderate in severity.

In the multiple ascending dose cohort, MBX 1416 median half-life was approximately 90 hours, supporting once-weekly administration, and at steady state the median Tmax was between 36 and 48 hours.

In the multiple ascending dose cohort, MBX 1416 increased GLP-1 within 60 minutes of a mixed meal tolerance test, suggesting a pharmacodynamic (PD) effect in healthy volunteers that may translate into a therapeutic benefit in PBH patients.

Consistent with the known GLP-1 antagonism effect on gastric motility, a slight acceleration of gastric emptying was observed with MBX 1416 based on acetaminophen exposure.  

In the drug-drug interaction portion of the trial, MBX 1416 was observed to have no meaningful effect on rosuvastatin exposure, a commonly prescribed statin.

MBX Biosciences ( MBX ) intends to discuss these results with the FDA in an End-of-Phase 1 meeting in mid-2025.

Pending alignment with the FDA, a Phase 2 study of MBX 1416 in patients with PBH is anticipated to initiate in the second half of 2025.

Price Action: MBX stock is down 7.22% at $15.11 at the last check Tuesday.

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