AstraZeneca’s $1bn hypoparathyroidism drug achieves success at Phase III

Eneboparatide, an investigational parathyroid hormone (PTH) receptor 1 agonist, met its primary endpoint in the Phase III Calypso trial for chronic hypoparathyroidism6.

The primary endpoint was a composite of normalisation of albumin-adjusted serum calcium levels and independence from active vitamin D and oral calcium therapy6.

AstraZeneca acquired eneboparatide through its $1.05 billion acquisition of Amolyt Pharma in July 202463.

The trial enrolled 202 patients who were evaluated for 24 weeks6.

Eneboparatide was well-tolerated across the 24-week period6.

The drug has been granted fast track and orphan drug designations by the FDA and orphan designation by the EMA6.

Hypoparathyroidism affects over 200,000 people in the US and European Union, with approximately 80% of patients being female6.

This success bolsters AstraZeneca's rare disease pipeline and expands its presence in rare endocrinology36.

Full efficacy and safety data will be analyzed again at 52 weeks, after which AstraZeneca plans to share data with global health authorities6.

Sources:

3. https://www.biospace.com/astrazeneca-closes-acquisition-of-amolyt-pharma

6. https://www.clinicaltrialsarena.com/news/astrazeneca-acquired-drug-scores-hypoparathyroidism/