MBX Biosciences announced the completion of an End-of-Phase 2 meeting with the U.S. Food and Drug Administration regarding its investigational therapy canvuparatide for chronic hypoparathyroidism, according to the company. The regulatory feedback supports the company’s plan to advance the treatment into a Phase 3 clinical trial.
Based on the discussions, MBX Biosciences plans to initiate a randomized, double-blind, placebo-controlled Phase 3 study in the third quarter of 2026. The planned trial is expected to enroll about 160 patients who will be randomized in a 3:1 ratio to receive canvuparatide or placebo.
According to the company, the study will begin with a four-week fixed-dose period followed by an 18-week dose titration phase and a four-week maintenance phase. The primary analysis is expected at week 26 and will evaluate the proportion of participants who achieve normal serum calcium levels while remaining independent from conventional therapy.
The company also reported that canvuparatide has received orphan drug designation from the European Medicines Agency for the treatment of chronic hypoparathyroidism, supporting its clinical development in Europe.
Canvuparatide is a parathyroid hormone peptide prodrug designed as a long-acting hormone replacement therapy with once-weekly dosing, developed using the company’s Precision Endocrine Peptide platform.
MBX Biosciences is a clinical-stage biopharmaceutical company developing peptide-based therapies targeting endocrine and metabolic disorders.
