• The ORION-11 trial of inclisiran sodium 300 mg reached all secondary and primary endpoints with efficacy that is consistent with the findings from Phase 2 and 1 trials.
   
• The trial evaluated that inclisiran was tolerated well and confirmed that its safety profile was as favorable as that shown in the ORION-3 and ORION-1 Phase 2 open-label extension studies.

The Medicines Company, a biopharmaceutical company dedicated to halt atherosclerosis progression and reduce cardiovascular risk, reportedly announced the positive topline outcomes of the first Phase 3 clinical trial examining the safety, tolerability and efficacy of inclisiran to reduce LDL-cholesterol by taking doses twice a year.

The ORION-11 trial of inclisiran sodium 300 mg reached all secondary and primary endpoints with efficacy that is consistent with findings from Phase 2 and 1 trials. The trial evaluated that inclisiran was tolerated well and confirmed that its safety profile was as favorable as that shown in the ORION-3 and ORION-1 Phase 2 open-label extension studies.

Detailed safety, tolerability and efficacy data from ORION-11 would be presented at a science session being conducted at the European Society of Cardiology’s ESC Congress 2019 in Paris on the 2^nd of September at 8:30 am Central European Time (CET).

Mark Timney, CEO at The Medicines Company stated that it is an important occasion that strengthens the company’s confidence on in the immense potential of inclisiran to radically change cardiovascular disease treatment.

Mark added that he was proud of the company’s clinical development department’s commitment to quickly and efficiently develop this top-quality investigational therapy which could help millions of patients of ASCVD to attain treatment goals, have healthier lives and live longer.

This global study took place at 70 different sites across seven countries, ex-U.S. Each trial participant was given inclisiran sodium 300 mg, initially given as a subcutaneous injection, then again after three months and every six months after first three months.

Source Credit: https://www.themedicinescompany.com/investor/pr/3992694/