Eneboparatide met primary Phase III endpoint, says AstraZeneca

High-level results from the CALYPSO Phase III trial showed that eneboparatide (AZP-3601), an investigational parathyroid hormone (PTH) receptor 1 agonist, met its primary endpoint with statistical significance in adults with chronic hypoparathyroidism (HypoPT) at 24 weeks, compared to placebo.

The primary endpoint is a composite of normalization of albumin-adjusted serum calcium levels and independence from active vitamin D and oral calcium therapy, said UK pharma major AstraZeneca (LSE: AZN), which acquired rights to the drug along with its acquisition of French firm Amolyt Pharma last year for a total consideration of up to $1.05 billion.

AstraZeneca noted that HypoPT is a rare endocrine disease caused by a deficiency of PTH and characterized by impaired regulation of calcium and phosphate levels in the blood. This dysregulation of the physiological action of PTH can lead to clinical manifestations, including negative impact on the kidney and bone. HypoPT is one of the largest known rare diseases, affecting over 200,000 people in the USA and the European Union, around 80% of whom are women.