Company: AZN
Filing Date: 2025-03-17
Form Type: 6-K
Source: 0001654954-25-002841
Chunk: 1

Company: ASTRAZENECA PLC
Filing Date: 2025-03-17
Form: 6-K
Chunk 1
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 from active vitamin D and oral calcium therapy.

HypoPT is a rare endocrine disease caused by a deficiency of PTH and characterised 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. 1 HypoPT is one of the largest known rare diseases, affecting over 200,000 people in the United States and the European Union, approximately 80% of whom are women. 2-4

Marc Dunoyer, Chief Executive Officer, Alexion, AstraZeneca Rare Disease, said: "People living with HypoPT, a rare endocrine disease, are often at increased risk of hypercalciuria, osteopenia and osteoporosis, and these results from the CALYPSO trial underscore eneboparatide's potential to be another option for these patients. We look forward to reviewing clinical results at 52 weeks to fully characterise the risk-benefit profile."

Eneboparatide was well tolerated. After the 24-week randomised treatment period, all patients receive eneboparatide in the ongoing long-term extension period until 52 weeks. Full efficacy and safety data will be analysed at 52 weeks. Alexion plans to share these data with global health authorities and present them at forthcoming medical meetings.

#### Notes

#### Hypoparathyroidism
Hypoparathyroidism (HypoPT) is a rare endocrine disease caused by a deficiency of parathyroid hormone (PTH) and characterised by decreased calcium and elevated phosphate levels in the blood, which can lead to a variety of neuromuscular, renal and skeletal manifestations. 1,5,6 The primary cause in approximately 75% of people with HypoPT is injury to or removal of the parathyroid glands during neck surgery. 5,6 There are over 200,000 people in the United States and the European Union living with HypoPT, approximately 80% of whom are women. 2-4 Despite available treatments, people living with HypoPT continue to experience a significant unmet need. 1,8

#### CALYPSO
CALYPSO is a global Phase III, randomised, double-blind, placebo-controlled, multicentre trial designed to evaluate the efficacy and safety of eneboparatide in adults with chronic hypoparathyroidism. A total of 202 patients treated with