MBX Biosciences announced it has dosed the first patient in its pivotal Phase 3 clinical trial, named "oPTimize," for its drug candidate canvuparatide. The trial will evaluate the efficacy and safety of the once-weekly treatment for adults with chronic hypoparathyroidism (HP).
Key Details
- Drug & Indication: The trial is for once-weekly canvuparatide, a potential treatment for chronic hypoparathyroidism, a rare endocrine disorder.
- Trial Design: The global, randomized, placebo-controlled study will enroll approximately 160 patients. It features a 26-week double-blind treatment period followed by a 78-week open-label extension.
- Primary Endpoint: The primary goal is to evaluate the proportion of patients at Week 26 who achieve normal calcium levels while becoming independent from active vitamin D and reducing calcium supplementation to ≤600 mg/day.