TMC announces detailed data from clinical study of siRNA lipid-lowering drug inclisiran III

recently,(http:// acompany at TMC,released detailed data on the siRNA fat-lowering
drug(http://inclisiran III clinical study ORION-10This is the second of three key Phase III clinical studies of the drug (ORION-9, ORION-10, ORION-11), and the results show that 2 subcutaneous injections of 300mg of inclisiran reached all major and secondary endpoints, with good tolerance and safetyThe ORION-10 study was a randomized, double-blind, placebo-controlled study conducted in 145 clinical centers in the United States and enrolled in a group of 1,561 patients with atherosclerosis cardiovascular disease (ASCVD), who had elevated LDL-C levels despite receiving the highest tolerable dose of LDL-C reduction therapy (such as statins or astantistins)In the study, patients were randomly assigned to receive inclisiran (300 mg dose, 0, 3 months, once every six months after a subcutaneous injection) or a placebo while receiving the largest dose of statins available to them (co-use or non-co-use of the folding wheat cloth)The main endpoint is the percentage change of LDL-C from baseline to 510th day (17 months) of treatment and percentage change in time adjustment of LDL-C relative to baseline from the 90th (3 months) of treatment to the 540th day (18 months)Key secondary endpoints include average absolute changes in the 510th day (17 months) of treatment, average absolute changes from day 90 (3 months) to 540th day (18 months), and changes in other lipids and lipoproteinsThe results showed that the study reached all primary and secondary endpointsIn the main endpoint, the ldLL-C level of inclisiran decreased by 58% (p 0.0001) on the 510th day of treatment and 56% (p 0.0001) on the 510th day of treatmentIn the study, the placebo group and the inclisiran treatment group had similar overall adverse events, with the same proportion of patients in both groups experiencing adverse events (26.3 percent vs 22.4 percent) and mortality (1.4 percent vs 1.5 percent) and malignant tumors (3.3 percent vs 3.3 percent) were comparableLiver functionin the placebo group and the inclisiran treatment group were similar in clinical significance to the clinical significance of the(http://(ALT 0.3% vs 0.3%; AST 0.6% vs 0.5%) and serum creatinine (3.9% vs 3.9%)0.9% of patients treated with placebo and 2.6% of patients treated with inclisiran reported clinically-related adverse events at the injection site, mainly mild and always short."