MBX Biosciences Plans 160-Patient Phase 3 Trial of Weekly Canvuparatide in Q3 2026
MBX Biosciences secured FDA feedback to commence a 160-patient, double-blind Phase 3 trial of once-weekly 600 mcg canvuparatide in Q3 2026, featuring a 4-week fixed dose, 18-week titration and 4-week maintenance period with primary efficacy assessed at Week 26. The therapy also earned EMA orphan drug designation for chronic hypoparathyroidism.
1. End-of-Phase 2 FDA Meeting
MBX Biosciences completed an End-of-Phase 2 meeting with the FDA to review once-weekly canvuparatide for chronic hypoparathyroidism, receiving constructive feedback on trial design elements and the regulatory path toward an NDA submission. Management confirmed plans to enroll the first patient in Q3 2026 now that key endpoints and safety criteria have been agreed.
2. Phase 3 Trial Design
The upcoming double-blind, placebo-controlled study will randomize approximately 160 patients in a 3:1 ratio to receive either 600 mcg canvuparatide or placebo. The protocol includes a 4-week fixed dose period, an 18-week dose-titration phase and a 4-week maintenance period, with primary efficacy assessed at Week 26 followed by an open-label extension to evaluate long-term safety and durability.
3. Orphan Drug Designation
Canvuparatide has received orphan drug status from the European Medicines Agency, complementing its U.S. designation, which supports accelerated development for the estimated more than 250,000 individuals affected by chronic hypoparathyroidism in the U.S. and Europe.