Efficacy and Safety of MT1013 compared to Etelcalcetide in patients with Secondary Hyperparathyroidism undergoing Maintenance Dialysis

 

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https://storage.unitedwebnetwork.com/files/1099/25f0b4017f71935a9caf815e648110e0.pdf
Efficacy and Safety of MT1013 compared to Etelcalcetide in patients with Secondary Hyperparathyroidism undergoing Maintenance Dialysis

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Ping
Zhang
Ping Zhang 13588016833@163.com The First Affiliated Hospital of Medical School of Zhejiang University Department of Nephrology Hangzhou China *
Jianghua Chen chenjianghua@zju.edu.cn The First Affiliated Hospital of Medical School of Zhejiang University Department of Nephrology Hangzhou China -
Bing Wang wangbing@micot.cn Shaanxi Micot Technology Limited Company CEO Xi'an China -
Xiangling Wang xiangling1116@163.com Shaanxi Micot Technology Limited Company CMO Beijing China -
Linyuan Wang linyuanw@pku.org.cn Shaanxi Micot Technology Limited Company Medical Department Shanghai China -
Zhian Huang huang6693504@126.com Shaanxi Micot Technology Limited Company Marketing Department Shanghai China -
Yu Zhi yuzhi3039@163.com Shaanxi Micot Technology Limited Company Department of Clinical Operation Shanghai China -
Lanlan Song songlanlan@micot.cn Shaanxi Micot Technology Limited Company Department of Clinical Operation Xi'an China -
Ruiling Wang wangruiling@micot.cn Shaanxi Micot Technology Limited Company Department of Clinical Pharmacology Xi'an China -
Xiaodong Wang 15140186875@163.com Shaanxi Micot Technology Limited Company Medical Department Shanghai China -
Hao Yu 516333049@qq.com Shaanxi Micot Technology Limited Company Department of Clinical Operation Shanghai China -
Chong Luo luochongqx@zju.edu.cn The First Affiliated Hospital of Medical School of Zhejiang University Department of Nephrology Hangzhou China -
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MT1013 is a first-in-class dual agonist targeting both the calcium-sensing receptor (CaSR) and osteogenic growth peptide (OGP). It is indicated for the treatment of SHPT in patients undergoing maintenance dialysis. In addition to its action on CaSR, MT1013 engages OGP—a target that promotes mesenchymal stem cell differentiation into osteoblasts and enhances bone formation. This dual mechanism further assists in regulating levels of iPTH, calcium, and phosphorus.

A head-to-head Phase II trial (NCT06690242) was conducted to compare two dose titration regimens of MT1013 with etelcalcetide and placebo, with 114 subjects included. All study drugs were administered intravenously three times per week. Efficacy and safety were assessed after 26 weeks of treatment.

After 26 weeks of treatment, both MT1013 groups demonstrated efficacy comparable to etelcalcetide in achieving >30% or >50% reductions in iPTH levels during the EAP (efficacy evaluation period). Specifically, >30% reduction rates were 83.9% (Group 1), 93.3% (Group 2), and 90.6% (etelcalcetide); >50% reduction rates were 74.2%, 80.0%, and 78.1%, respectively. The target achievement rates for iPTH (2–9×ULN), calcium (2.1–2.5 mmol/L), and phosphorus (1.13–1.78 mmol/L), both individually and compositely, were higher in the MT1013 groups than in the etelcalcetide group during the EAP. The composite target achievement rate was 42.86% in MT1013 Group 1, 33.33% in MT1013 Group 2, and 15.63% in the etelcalcetide group. A trend toward superiority of MT1013 was also observed in the magnitude of FGF-23 reduction, with decreases of 33.5% and 39.9% in the two MT1013 groups, compared to 22.8% in the etelcalcetide group. Similarly, a higher proportion of subjects achieved a >30% reduction in FGF-23 in the MT1013 groups (58.6% and 66.7%) than in the etelcalcetide group (50%). These results suggest MT1013 may reduce cardiovascular risk and improve prognosis. It was well tolerated in CKD-SHPT patients, with no severe TEAEs, drug-related SAEs, or new safety signals. A lower rate of symptomatic hypocalcemia in the MT1013 group was observed, compared to etelcalcetide group.

MT1013 outperforms etelcalcetide with higher on-target rates for iPTH, Ca, and P. Its dual-targeting mechanism provides holistic control of mineral metabolism and FGF-23, offering potential for improved patient prognosis.

The study, MT1013 C03, had partial data submitted to the American Society of Nephrology (ASN) late-breaking session in September 2025

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