Eli Lilly's Once-Weekly Subcutaneous Injection for Kidney Disease Receives IND Approval in China

Aug 31, 2024 08:32 CST Updated 08:32

Eli Lilly

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August 30,The latest announcement on the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) reveals that Eli Lilly and Company（Eli Lilly and Company）DeclaredLY3540378 Injection Approved for Clinical Use,Intended to be developed for the treatment ofPatients with Chronic Kidney Disease (CKD). Public information shows,LY3540378（volenrelaxin）It is being researched by Eli Lilly and CompanyLong-actingEffective Agonist of Relaxin Family Peptide Receptor 1 (RXFP1), currently in Phase 2 clinical trials internationally.

Screenshot source:CDE Official Website

Relaxin is a human peptide hormone that regulates cardiovascular, renal, and pulmonary adaptations during pregnancy. It was initially named for its ability to soften the birth canal in preparation for labor. Subsequent studies have demonstrated relaxin's role in the cardio-renal system. Research has shown that both relaxin and its receptor RXFP1 are expressed in the kidneys, where relaxin has been proven to play a role in renal vasodilation, sodium excretion, and anti-fibrosis.

VolenrelaxinIs a recombinant human relaxin protein with an extended half-life, produced byHuman Relaxin Analogand Serum AlbuminComposed of VHH domains,Developed to improve renal perfusion and cardio-renal function。

According to a publication reported in May this year, a Phase 1 study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of volenrelaxin after single and multiple doses (SAD and MAD). In this four-part randomized, double-blind, placebo-controlled SAD and MAD study involving healthy participants, SAD participants received escalating doses of volenrelaxin or placebo via intravenous or subcutaneous administration, while MAD participants received volenrelaxin or placebo subcutaneously once weekly for 5 weeks.

The study results show that Volenrelaxin is well-tolerated and safe.Suitable for weekly subcutaneous administration. In addition, the product showsContinuous improvement in renal perfusion supports further clinical development in chronic kidney disease and chronic heart failure.。

According toClinicalTrialsOfficial website, Eli Lilly and Company is currently conducting volenrelaxin treatmentHeart Failure with Preserved Ejection Fraction(Phase 2 clinical study of HFpEF). The recent approval in China for the IND to treat chronic kidney disease indicates that clinical trials for this indication will be conducted in China.

References:

[1] Official website of the Center for Drug Evaluation, National Medical Products Administration of China. Retrieved Aug 31, 2024, from https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c

[2]Lai San Tham, et al. Volenrelaxin (LY3540378) increases renal plasma flow: a randomized Phase 1 trial, Nephrology Dialysis Transplantation, 2024;, gfae112, https://doi.org/10.1093/ndt/gfae112

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