MBX Biosciences reports sustained one-year data for weekly drug trial

MBX Biosciences Inc. (NASDAQ: MBX) reported one-year data from an open-label extension study of canvuparatide, an experimental once-weekly treatment for chronic hypoparathyroidism.

The company said 57% of evaluable patients achieved responder status at one year, compared to 63% at 12 weeks in the Phase 2 Avail trial. The responder rate measures patients who maintained normal serum calcium levels while independent from conventional therapy.

The study showed 90% of patients who entered the open-label extension remained in the study at one year. Mean serum calcium levels were maintained within normal range through one year of treatment, while urine calcium levels decreased and remained within normal range.

Kidney function measurements showed mean estimated glomerular filtration rate increased from baseline and remained improved through one year. Bone metabolism markers demonstrated patterns consistent with parathyroid hormone replacement therapy.

The drug was generally well tolerated with no new safety signals during the extension study. Most adverse events were mild or moderate in severity, with injection site reactions reported in 10% of patients. No treatment-related serious adverse events were reported.

Pharmacokinetic data showed consistent drug concentration with minimal fluctuation and a peak-to-trough ratio of approximately 1.3 over a week.

MBX Biosciences said it remains on track to initiate a Phase 3 trial in the third quarter of 2026. The company estimates hypoparathyroidism affects more than 250,000 individuals in the United States and Europe.

Canvuparatide has received orphan drug designation from the Food and Drug Administration for treating hypoparathyroidism.

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