Phase III study of inclisiran meets all goals

26 August 2019

Shares of The Medicines Company (Nasdaq: MDCO) were up 24% pre-market after it announced positive top-line results from the first pivotal Phase III clinical trial evaluating the efficacy, safety, and tolerability of PCSK9 drug inclisiran to decrease LDL-cholesterol (LDL-C) through twice-yearly dosing.

The ORION-11 study of inclisiran sodium 300mg met all primary and secondary endpoints with efficacy consistent with findings from Phase I and II studies. The trial showed that inclisiran was well tolerated and confirmed that the safety profile was at least as favorable as that demonstrated in the ORION-1 Phase II and ORION-3 open label extension studies.

Detailed efficacy, tolerability and safety data from ORION-11 will be presented during a late-breaking science session at the European Society of Cardiology’s ESC Congress 2019, Paris, on September 2.

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