MBX Biosciences (NASDAQ:MBX) stock surged 16% after announcing that its investigational therapy canvuparatide, a once-weekly injection, successfully met the primary endpoint in a Phase 2 trial for chronic hypoparathyroidism.
The company said 63% of patients on canvuparatide achieved the composite endpoint at 12 weeks, compared with 31% in the placebo arm, reaching statistical significance (p=0.042). The trial measured the ability of patients to sustain normal calcium levels without needing conventional therapy.
All 64 participants completed the 12-week trial, and 94% chose to move into the open-label extension (OLE). By six months in the OLE, the responder rate climbed to 79%.
“These data reinforce our conviction that canvuparatide could become a potential best-in-class treatment for hypoparathyroidism,” said Kent Hawryluk, President and CEO of MBX Biosciences.
The treatment also showed improvements in bone turnover markers and cut urine calcium levels by 48% in patients who started with elevated values, which normalized by Week 12.
Safety findings were positive, with no serious adverse events tied to treatment and no patient withdrawals. Injection site reactions were reported in 19% of those on canvuparatide, compared with 13% in the placebo group.
Dr. Mishaela Rubin, one of the study investigators, said, “A once-weekly therapy could simplify administration and help address important unmet medical needs of patients with hypoparathyroidism.”
With these results, MBX plans to launch a Phase 3 program in 2026 and intends to present more detailed findings at an upcoming medical conference.
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