AstraZeneca's Class 1 Peptide Drug Eneboparatide Approved for Clinical Trials in China Following $1.05B Acquisition of Amolyt Pharma

Mar 27, 2025 15:11 CST Updated 15:11

Alexion

Developer of New Drugs for Rare Disease Treatment

AstraZeneca

Biopharmaceutical Manufacturer

▎WuXi AppTec Content Team Report

Today (March 27),The official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has recently announced,AstraZenecaUnder its focus on the rare disease fieldAlexion's New Drug Application for Eneboparatide Injection Approved for Clinical Trials, Intended for Development in TreatmentChronic Hypoparathyroidism. Public information shows,This is a therapeutic peptide with an innovative mechanism of action. In March 2024, AstraZeneca announced a $1.05 billionAcquisitionAmolyt Pharma, a biotechnology company in the field of rare endocrine diseases, thereby acquiring the Phase 3 clinical-stage development project named eneboparatide (AZP-3601).

Screenshot source:CDE Official Website

Hypoparathyroidism (HypoPT) is a rare endocrine disorder,Patients with insufficient production of parathyroid hormone (PTH) experience severe dysregulation of calcium and phosphorus., characterized by decreased calcium levels and increased phosphorus levels in the blood, which may lead to life-altering symptoms and complications, including adverse effects on the kidneys and bones. It is one of the rare diseases with the highest known number of patients, with approximately 80% being female.

Eneboparatide isA parathyroid hormone receptor 1 (PTHR1) agonist,It restores PTH function by binding to a specific conformation of PTHR1, thereby managing symptoms in HypoPT patients while preserving renal function and bone health, aiming to meet the treatment goals for hypoparathyroidism.. The product has been granted Fast Track designation and Orphan Drug designation by the U.S. FDA, and Orphan Drug designation by the European Medicines Agency for the treatment of HypoPT.

Previously, Phase 2 clinical trial data showed that eneboparatideNormalization of serum calcium levels was achieved, potentially eliminating the need for daily calcium and vitamin D supplements.. In adults with chronic hypoparathyroidism and hypercalciuria, this productNormalizing calcium levels in urine helps prevent the occurrence of chronic kidney disease.In addition, eneboparatide also maintained bone mineral density, which is an important potential benefit for patients at increased risk of osteoporosis or osteopenia.

In March 2025, AstraZeneca announced that the CALYPSO study had reached its primary endpoint at 24 weeks. CALYPSO is a global Phase 3 clinical trial designed to evaluate the efficacy and safety of eneboparatide treatment in patients with HypoPT. A total of 202 patients receiving standard treatment (active vitamin D and oral calcium supplementation) were randomly assigned in a 2:1 ratio to receive either eneboparatide or placebo. The trial met its composite endpoint at 24 weeks.Normalization of serum calcium levels after albumin correction, and no reliance on vitamin D and oral calcium treatmentThe press release stated that the study will continue, with all patients receiving extended eneboparatide treatment for up to 52 weeks. Afterward, researchers will analyze the comprehensive efficacy and safety data.

The approval of this innovative peptide drug for clinical trials in China means that it is about to commence clinical research in the country.

References:

[1] Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China.Retrieved Mar 27，2025, From https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c

[2]Eneboparatide met primary endpoint of normalising serum calcium in adults with hypoparathyroidism at 24 weeks in CALYPSO Phase III trial. Retrieved March 17, 2025, from https://www.astrazeneca.com/media-centre/press-releases/2025/eneboparatide-phase-iii-trial-met-primary-endpoint.html

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