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CKD (chronic kidney disease) is a long-term medical condition, Anemia is a common complication of CKD, it can contribute to the overall burden of CKD by worsening fatigue, reducing quality of life, and increasing the risk of other complications.
A safer and more cost-effective EPO (erythropoietin) is essential to improve patient outcomes in CKD anemia, reduce the economic burden on healthcare systems and patients, and make treatment more accessible and sustainable on a global scale.
A randomized, double-blind, Phase I clinical study (CTR20221413) was conducted. 48 healthy subjects were randomly divided into six groups to receive a single s.c. dose of 0.5 µg/kg, 1.6 µg/kg , 5 µg/kg , 15 µg/kg, 30 µg/kg, 50 µg/kg respectively. In total of 20 healthy subjects were randomized divided into 2 groups to receive 4 s.c. doses of 15 µg/kg and 30 µg/kg respectively
Safety, pharmacokinetics, and pharmacodynamics profile was evaluated.
LP-001 has a bioactivity comparable to Aranesp in both cell based assay (UT-7) and in-vivo animal models (normal SD rats, carboplatin induced anemia in SD rats and with cyclophosphamide induced anemia in cynomolgus monkey. The bioavailability of LP-001 is around 50% in normal SD rats and monkeys.
In SAD of phase I study, LP-001 exhibited a non-linear PK characteristic with T1/2 ranging from 65.8 hrs to 107hrs, which is comparable to Aranesp. No ADA and grade 3 or above AE were observed.
The pre-clinical and phase I study of LP-001 suggests that this novel long-acting EPO has a comparable glycosylation form and half-life to Aranesp. Moreover, it can improve the EPO level more smoothly therefore renders a potential safer and cost-effective ESA that might be alternative for CKD treatment.