The Medicines Company (NASDAQ:MDCO) announces positive results from two Phase 3 clinical trials for inclisiran. Both studies met all primary and secondary endpoints with no new safety signals reported. Detailed data will be presented at the American Heart Association Scientific Sessions in Philadelphia in mid-November.
ORION-9 in patients with heterozygous familial hypercholesterolemia.
ORION-10 in patients with atherosclerotic cardiovascular disease.
The company reported successful results from another Phase 3, ORION-11, on September 3.
Inclisiran is an investigational GalNAc-conjugated RNAi therapeutic targeting PCSK9, a protein regulator of LDL receptor metabolism. In contrast to PCSK9 inhibitors (like Amgen’s Repatha and Regeneron and Sanofi’s Praluent), PCSK9si works by turning off PCSK9 synthesis in the liver. MDCO is collaborating with Alnylam Pharmaceuticals (NASDAQ:ALNY) on development under a 2013 agreement.
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