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Early-stage data show PCSK9si lowered bad cholesterol for at least six months

Published 11/14/2016, 08:47 AM
Updated 11/14/2016, 08:47 AM
Early-stage data show PCSK9si lowered bad cholesterol for at least six months
  • Alnylam Pharmaceuticals (NASDAQ:ALNY) is up 2% premarket and collaboration partner The Medicines Company (NASDAQ:MDCO) is up 8%, both on light volume, in response to increasing optimism regarding cholesterol-lowering candidate inclisiran (PCSK9si), an investigational GalNAc-conjugated RNAi therapeutic targeting PCSK9, a protein regulator of LDL receptor metabolism. It lowers bad cholesterol (LDL-C) by turning off PCSK9 synthesis in the liver.
  • Results from a Phase 1 study was just published in The New England Journal of Medicine. The data showed doses of at least 300 mg (single or multiple) significantly lowered PCSK9 and LDL cholesterol for at least six months and was generally well-tolerated.
  • Specifically, single doses of inclisiran of at least 300 mg reduced PCSK9 74.5% at Day 84. Doses at least 100 mg reduced LDL-C 50.6% at Day 84. The reductions were maintained at Day 180 will minor variation at doses at least 300 mg. Multiple doses reduced PCSK9 and LDL-C 83.8% and 59.7%, respectively, at Day 84. Levels remained reduced in all cohorts at Day 196.
  • No serious adverse events were observed following single and multiple subcutaneous injections. All observed adverse events were mild or moderate in severity.
  • Inclisiran was initially developed by Alnylam. The Medicines Company assumed the role of lead developer in August 2015. 180-day follow-up data from the Phase 2 ORION-1 study will be presented tomorrow, November 15, at the American Heart Association Annual Meeting in New Orleans, LA. Management will host a conference call at 3:00 pm ET tomorrow to discuss the results.

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