AstraZeneca announced that eneboparatide (AZP-3601), an investigational parathyroid hormone receptor 1 agonist, met the primary endpoint in the CALYPSO Phase III trial for chronic hypoparathyroidism (HypoPT). The treatment demonstrated statistical significance in normalizing serum calcium levels and eliminating the need for active vitamin D and oral calcium therapy after 24 weeks.

HypoPT is a rare endocrine disorder affecting over 200,000 people in the US and EU, with 80% of cases occurring in women. It results in impaired calcium and phosphate regulation, leading to complications such as hypercalciuria, osteopenia, and osteoporosis.

Marc Dunoyer, CEO of Alexion, AstraZeneca Rare Disease, highlighted the potential of eneboparatide as a new treatment option and emphasized the importance of completing the 52-week trial to fully assess its risk-benefit profile. The trial's extension period will continue until week 52, after which AstraZeneca plans to present full safety and efficacy data to global health authorities.

Eneboparatide has received fast-track and orphan drug designation from the US FDA and orphan designation from the European Medicines Agency. The treatment aims to restore parathyroid hormone function while preserving kidney function and bone health.

For more information, visit www.alexion.us or www.astrazeneca-us.com.