MBX Biosciences Advances Canvuparatide Into Phase 3 Development For Hypoparathyroidism

(RTTNews) - MBX Biosciences (MBX) announced that the first patient has been dosed in its pivotal Phase 3 oPTimize trial evaluating once-weekly canvuparatide for the treatment of chronic hypoparathyroidism (HP).

The global, multicenter, randomized, double-blind, placebo-controlled study is expected to enroll approximately 160 adults with chronic HP.

Patients will be randomized 3:1 to receive canvuparatide or placebo during the 26-week double-blind treatment period, followed by a 78-week open-label extension.

The primary endpoint will assess the proportion of patients achieving a composite responder outcome at Week 26, including maintaining normal serum calcium, becoming independent of active vitamin D, reducing calcium supplementation to 600 mg or less per day, and avoiding increases in study drug dose during the four weeks before assessment.

Key secondary endpoints include normalization of urinary calcium excretion, improvements in physical functioning and hypocalcemia-related symptoms, as well as measures of bone metabolism, kidney health and long-term safety.

Canvuparatide is an investigational long-acting parathyroid hormone peptide prodrug designed to provide continuous, infusion-like exposure to active PTH through a once-weekly subcutaneous injection.

The program builds on positive Phase 2 Avail results and one-year data showing effects consistent with restoration of systemic PTH activity, including normalized serum calcium, reduced urinary calcium excretion, improved bone metabolism and increased eGFR.

MBX said the Phase 3 program represents a key step toward potential registration of canvuparatide as a once-weekly PTH replacement therapy for adults with chronic hypoparathyroidism.

MBX has traded between $9.63 and $72.64 over the last year.

The stock closed Wednesday's trading at $66.76.

In pre-market trading the stock is at $68.00, up 1.86%.