Reducing bad cholesterol levels 54% RNAi Innovative Therapy Shines at the Annual Meeting of the European College of Cardiology

The results of the ORION-11 trial (Photo: Resources 2)Inclisiran is the first RNAi therapy to reduce LDL-CIt binds directly to mRNAs that encode the PCSK9 protein, reducing mRNA levels through RNA interference, thus preventing the liver from producing PCSK9 proteinsThe pcSK9 protein is used to inhibit the recovery and reuse of LDL receptorsTherefore, lowering the level of the PCSK9 protein allows more LDL receptors to return to the surface of liver cells, bind to more LDLs, and remove them from the bloodHowever, the safety of drugs is also a concern compared to effectivenessInclisiran is a targeted PCSK9 RNAi therapy designed using Alnylam Pharmaceuticals' GalNAc delivery systemAlthough this technology platform improves drug stability and facilitates liver-targeted delivery of RNAi therapies, its potential liver toxicity is a concernPreviously, Inclisiran had shown better safety in the early stages of clinical trials, but whether that was the case remains to be seencomfortingly, the safety of inclisiran was further validated in this Orion-11 trialAccording to The Medicines Company, changes in liver function indicators were broadly the same between placebo and inclisiran groups, with ALT 0.5% vs0.5% vs0.5% aST vs0.2%In terms of kidney function, the blood creatinine increased by 3.9% and 2.5% respectively" based on the size of the Phase 3 study, we can now confirm that this RNAi treatment is very safe and does not cause damage to liver or kidney functionMark Timney, chief executive of The Medicines Company, said the safety and tolerance data for the ORION-11 trial (Photo: Source: Supplied, 2) long-standing high levels of LDL-C are considered to be associated with a high risk of cardiovascular disease The ability to reduce LDL-C is important for this PCSK9 inhibitor, but reducing the risk of cardiovascular events is equally important Especially when Praluent and Repatha each posted positive results in the trial, the researchers noted statistically significant differences in the placebo and inclisiran groups in the incidence of heart disease (2.7 percent vs 1.2 percent) and stroke rates (1.0 percent vs 0.2 percent) This data bodes well for the treatment in the Orion-4 trial It is reported that Orion-4's findings will be published in 2024 / ORION-11: Adverse Cardiovascular events (Photo: Resources, 2) In the Orion-11 trial, the subjects were patients with atherosclerosis cardiovascular disease (ASCVD) from outside the United States, the first Phase 3 trial results published by inclisiran Two other Orion-9 trials for familial hypercholesterolemia and Orion-10 trials for U.S patients are expected to be released later this year Based on the three findings, The Pharmaceuticals Company said it would submit applications for new drugs to the FDA and the European Drug Enforcement Administration at the end of the year and early 2020, respectively So far, several PCSK9 inhibitors have been approved by the FDA, and the advantage of inclisiran is that patients only need to receive 2 subcutaneous injections a year to control cholesterol levels, providing patients with a very convenient treatment option It is reported that the company is currently preparing for the commercialization of the product in China, the first PCSK9 inhibitor came from Amgen's Repatha, which was approved in China last July for pure-cogen family hypercholesterolemia (HoFH), and has since been approved for a second indication: atherosclerosis cardiovascular disease Sanofi's application for the import listing of Praluent has been included in the priority review by the Drug Review Center of the State Drug Administration of China and is expected to be approved soon In addition, Hengrui Pharmaceuticals, Cinda Bio, Junshi Bio and other enterprises are also layout of this field References: s1 s1 smedCo's PCSK9 challenger steals the show at ESC with winning data Retrieved Sep 2, 2019, from https:// 2? Retrieved Sep 2, 2019, from https://