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MBX Biosciences Announces One-Year Data Demonstrating Sustained Benefit of Once-Weekly Canvuparatide as a Potential PTH Replacement Therapy in Chronic Hypoparathyroidism

  • MBX Biosciences reported a 57% responder rate at one year in the open-label extension (OLE) study, comparable to the 63% rate observed at 12 weeks in the Phase 2 Avail™ trial.
  • 90% of patients who entered the OLE remained in the study at one year.
  • Treatment with once-weekly canvuparatide demonstrated restoration of systemic PTH activity through serum calcium normalization, reduced urine calcium excretion, improved bone metabolism, and increased eGFR.
  • Pharmacokinetic data supported once-weekly dosing with a low peak-to-trough ratio of approximately 1.3 and stable drug exposure.
  • Canvuparatide was generally well tolerated with no new safety signals; most adverse events were mild or moderate, with injection site reactions reported in 10% of patients.
  • The company remains on track to initiate a Phase 3 pivotal trial in Q3 2026.
  • Full results from the 12-week Phase 2 trial and one-year OLE data will be presented at the 3rd Parathyroid Summit during ENDO 2026 in Chicago.
  • MBX Biosciences hosted a conference call at 8:00 a.m. ET to discuss the clinical data with company management and clinical advisors.