Clinical TrialJun 12, 2026, 07:02 AM
MBX Biosciences Canvuparatide Shows 57% Responder Rate at One Year
AI Summary
MBX Biosciences announced positive full results from its 12-week Avail™ Phase 2 trial and new one-year data from the open-label extension (OLE) study of once-weekly canvuparatide for chronic hypoparathyroidism. The OLE showed a 57% responder rate at one year, comparable to the 63% at 12 weeks in Phase 2, with 90% patient retention. The drug was well tolerated, demonstrated consistent PTH activity, improved kidney function, and normalized bone metabolism. The company remains on track to initiate its Phase 3 pivotal trial in Q3 2026.
Key Highlights
- Canvuparatide achieved a 57% responder rate at one year in the OLE study.
- The 12-week Phase 2 Avail™ trial showed a 63% responder rate for canvuparatide vs 31% for placebo (p=0.042).
- 90% of patients entering the OLE remained in the study at one year.
- Canvuparatide was generally well tolerated with no new safety signals in the OLE.
- PK data supports once-weekly dosing with a peak-to-trough ratio of approximately 1.3.
- Mean serum calcium levels were maintained in the normal range through one year.
- Mean eGFR increased from baseline at Week 12 and remained improved through one year.
- Phase 3 pivotal trial remains on track to initiate in Q3 2026.
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