other material
confidence high
sentiment positive
materiality 0.70
MBX Biosciences doses first patient in Phase 3 oPTimize trial of canvuparatide for hypoparathyroidism
MBX Biosciences, Inc.
- First patient dosed in pivotal Phase 3 oPTimize trial (NCT07699471) of once-weekly canvuparatide in chronic hypoparathyroidism.
- Trial enrolls ~160 adults, randomized 3:1 canvuparatide vs placebo over 26-week double-blind period, then 78-week open-label extension.
- Primary endpoint: composite responder at Week 26 (normal serum calcium, no active vitamin D, calcium ≤600 mg/day, no dose increase).
- Builds on positive Phase 2 Avail results showing normalized serum calcium, reduced urinary calcium, restored bone metabolism, increased eGFR.
- Canvuparatide administered once weekly using commercial-intent device; CEO cites potential as new standard of care.