What This Cholesterol Study Means Going Forward

Health and Healthcare

Published: August 26, 2019 9:35 am

Last Updated: January 30, 2020 4:58 pm

The Medicines Co. (NASDAQ: MDCO) shares jumped early on Monday after the firm announced results from its late-stage cholesterol study. Specifically, it reported results from its Phase 3 study of inclisiran.

The Orion-11 study of inclisiran met all primary and secondary endpoints with efficacy consistent with findings from Phase 1 and 2 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 2 and Orion-3 open-label extension studies.

The primary endpoints are percentage change in LDL-cholesterol (LDL-C) from baseline to day 510 (17 months) and time-adjusted percentage change in LDL-C from baseline after day 90 (three months) and up to day 540 (18 months).

Key secondary endpoints include the mean absolute change at Day 510 (17 months), the average absolute reduction from Day 90 (three months) up to Day 540 (18 months), and changes in other lipids and lipoproteins.

CEO Mark Timney commented:

This is a momentous occasion that further reinforces our confidence in the tremendous potential of inclisiran to fundamentally change the treatment of cardiovascular disease. I am proud of our clinical development team’s commitment to expeditiously advance this first-in-class investigational therapy that could help millions of ASCVD patients achieve treatment goals and live longer, healthier lives.

Shares of Medicines Company closed on Friday at $35.03 but opened Monday at $38.50. The 52-week range is $16.69 to $41.33, and the consensus analyst price target is $56.71.

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