Eli Lilly Gets CDSCO Panel Nod to Study Lepodisiran
New Delhi: The drug major Eli Lilly has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase III clinical trial for Lepodisiran, an extended-duration short-interfering RNA targeting lipoprotein.
This came after Eli Lilly presented Phase III clinical trial study protocol No. J3L-MC-EZEF dated 17 December 2023. The purpose of this study is to evaluate the efficacy of lepodisiran in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke. The study drug will be administered subcutaneously (SC) (under the skin).
Lepodisiran is a small interfering RNA that lowers Lipoprotein (a) [Lp(a)] by blocking the production in the liver of a key protein component of the Lp(a) particle. Levels of Lp(a) are determined predominantly by genetics rather than lifestyle, and Lp(a) is not frequently measured because there are no treatments currently available.
Although this is a unique short-interfering RNA structure, the exact mechanism by which lepodisiran produces such long-term effects remains uncertain. After injection, this therapeutic agent produced dose-dependent increases in plasma concentrations that persisted for less than 48 hours.
At the recent SEC meeting for Cardiovascular held on 4th April 2024, the expert panel reviewed the Phase III clinical trial study protocol No. J3L-MC-EZEF dated 17 December 2023.
After detailed deliberation, the committee recommended the grant of permission to conduct the trial as presented by the firm with the following conditions:
1. The kidney function tests (KFT) assessment including the Glomerular filtration rate (GFR)and urinary tract infection (UTI) test at 3 months shall be included in the inclusion criteria. Accordingly, the expert panel suggested that Chronic Kidney Disease (CKD) patients should also be included if fulfill the said criteria.
2. Patients diagnosed with low GFR undergoing any form of hemodialysis should be excluded from the study.
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