Physicians' Academy for Cardiovascular Education

siRNA therapy and LDL-C

Follow news on the evolving field of siRNA therapy and lowerting of LDL-c

PCSK9 siRNA recommended by CHMP for EU approval

News - Oct. 28, 2020

Following the results from the ORION program, the CHMP of EMA has issued a positive opinion on inclisiran to reduce LDL-c in patients with hypercholesterolemia or mixed dyslipidemia.

In high-risk primary prevention individuals, RNAi against PCKS9 reduces LDL-c

News - Oct. 6, 2020

EAS 2020 In a cohort of high-risk primary prevention individuals, 6-monthly injections with inclisiran reduced LDL-c and other atherogenic lipoproteins compared to placebo.

LDL-c lowering by RNAi against PCKS9 similar across HeFH genotype subgroups

News - Oct. 6, 2020

EAS 2020 A subanalysis of ORION-9 showed that lowering of LDL-c by inclisiran was similar across subgroups of genotypes in those with heterozygous FH.

PCSK9 siRNA does not affect inflammation measures or hematological parameters

Literature - Apr. 28, 2020 - Landmesser U et al., - Cardiovasc Res. 2020.

Inclisiran, an siRNA against PCSK9, did not result in adverse effects on measures of inflammation, immune activation and platelets. No clinical immunogenicity AEs were observed.

APOC3 RNA silencing therapeutic safely lowers triglycerides

News - Nov. 25, 2019

AHA 2019 The siRNA ARO-APOC3 prevents production of APOC3 through RNA interference. It lowered levels of APOC3, TG and VLDL-c and increased HDL-c, and was well tolerated.

PCSK9 siRNA, on top of maximally tolerated statin therapy, potently lowers LDL-c

3' education - Nov. 16, 2019 - R. Scott Wright, MD, Rochester, MN, USA - AHA 2019, Philadelphia
The ORION-10 trial met all its primary and secundary efficacy endpoints, with a good safety profile, up to 17 months.

AHA 2019 The ORION-10 trial met all its primary and secundary efficacy endpoints, with a good safety profile, up to 17 months.

Potent and durable LDL-c lowering up to 18 months with siRNA against PCSK9

News - Nov. 16, 2019

AHA 2019 The ORION-10 results showed LDL-c lowering of over 50% with inclisiran, an inhibitor of PCSK9 through RNA interference, with a safety profile similar to placebo.

Two phase 3 studies with siRNA against PCSK9 meet primary endpoints

News - Oct. 2, 2019

Topline results of ORION-9 and ORION-10 showed durable and potent efficacy and safety of twice-yearly injections of inclisiran in HeFH patients and participants with ASCVD, respectively.

Targeting PCSK9: Expanding knowledge and targeting new frontiers

10' education - Sep. 24, 2019 - Paris, France - Prof. John Kastelein, MD
Prof. Kastelein discusses new strategies to target PCSK9, including twice-a-year injections of inclisiran and a newly developed oral PCSK9 inhibitor.

Prof. Kastelein discusses new strategies to target PCSK9, including twice-a-year injections of inclisiran and a newly developed oral PCSK9 inhibitor.

LDL-c lowering with twice-a-year injection of siRNA against PCSK9: The ORION-11 trial

10' education - Sep. 16, 2019 - Prof. John Kastelein
Prof. John Kastelein shares the results of the phase 3 ORION-11 trial with inclisiran in ASCVD and risk equivalent patients not at LDL-C goal.

ESC 2019 Prof. John Kastelein shares the results of the phase 3 ORION-11 trial with inclisiran in ASCVD and risk equivalent patients not at LDL-C goal.

Primary and secondary efficacy endpoints met with siRNA against PCSK9

News - Aug. 27, 2019

Phase 3 ORION-11 results up to 18 months show efficacy of inclisiran, which prevents production of the PCSK9 protein, consistent with earlier studies and an at least as favorable safety profile.

Pilot study shows sustained LDL-c reduction with PCSK9-siRNA in hoFH patients

News - May 28, 2019
The pilot ORION-2 study shows that inclisiran, an siRNA that prevents production of PCSK9, yielded persistent lowering of LDL-c levels up to 6 months in 3 out of 4 hoFH patients.

EAS 2019 The pilot ORION-2 study shows that inclisiran, an siRNA that prevents production of PCSK9, yielded persistent lowering of LDL-c levels up to 6 months in 3 out of 4 hoFH patients.