MBX Biosciences advances once-weekly canvuparatide to phase 3 trial

By Chris Stiles • Monday, March 09 09:45 • Permanent Link

MBX Biosciences, a clinical-stage biopharmaceutical company, has recently completed a successful end-of-phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) regarding the development of once-weekly canvuparatide for the treatment of chronic hypoparathyroidism (HP). The company is pleased to announce that based on the feedback from the FDA, it plans to advance once-weekly canvuparatide into a phase 3 trial in the third quarter of 2026.

The phase 3 trial will enroll approximately 160 patients, randomized in a 3:1 ratio to receive canvuparatide or placebo. The trial will consist of a 4-week fixed dose period, followed by an 18-week dose-titration period and a 4-week maintenance period. The primary efficacy analysis will be assessed at week 26, followed by a transition to an open-label extension to assess both long-term safety and durability of the effect.

Furthermore, the company has announced that once-weekly canvuparatide has been granted orphan drug designation by the European Medicines Agency for the treatment of chronic hypoparathyroidism, supporting its continued clinical development in Europe.

Canvuparatide is a parathyroid hormone peptide prodrug designed to provide convenient, once-weekly administration and continuous, infusion-like PTH exposure with lower daily peak-to-trough ratios than observed with daily PTH dosing regimens. It has also received orphan drug designation from the U.S. FDA for the treatment of HP.

Hypoparathyroidism is a rare endocrine disease caused by a deficiency of parathyroid hormone (PTH) that results in decreased calcium levels in the blood, leading to hypocalcemia. MBX Biosciences estimates that HP affects more than 250,000 individuals in the U.S. and Europe. The current standard of care for HP primarily consists of high doses of oral calcium and active vitamin D supplements.

MBX Biosciences is dedicated to the discovery, development, and commercialization of novel precision peptide therapies for the treatment of endocrine and metabolic disorders. In addition to once-weekly canvuparatide, the company's pipeline includes candidates for the treatment of obesity and post-bariatric hypoglycemia.

Following these announcements, the company's shares moved -0.93%, and are now trading at a price of $40.53. For more information, read the company's full 8-K submission here.

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