Why This Late-Stage LDL-Cholesterol Study Could Be a Big Hit

By Chris Lange Updated Jan 30, 4:42PM EST · Published Sep 3, 10:50AM EDT

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Why This Late-Stage LDL-Cholesterol Study Could Be a Big Hit — © designer491 /iStock

The Medicines Co. (NASDAQ: MDCO) shares made a handy gain on Tuesday after the firm announced results from its late-stage trial in the treatment of low-density lipoprotein cholesterol (LDL-C). Specifically, the data came from the Phase 3 Orion-11 study of inclisiran, the first and only cholesterol-lowering therapy in the siRNA (small-interfering RNA) class.

Ultimately, the study met all primary and secondary efficacy endpoints, was well tolerated and demonstrated an excellent safety profile.

For the primary endpoints of Orion-11, inclisiran delivered placebo-adjusted LDL-C reductions of 54% at day 510 and demonstrated time-averaged placebo-adjusted LDL-C reductions of 50% from days 90 through 540.

Looking ahead, Orion-11 data will be submitted to a peer-reviewed medical journal. The sequential release of topline Phase 3 data readouts for the Orion-9 and Orion-10 studies is expected to continue later in the third quarter in advance of anticipated regulatory submissions in the United States in the fourth quarter of 2019 and in Europe in the first quarter of 2020.

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Kausik Ray, M.D., principal investigator of ORION-11, professor of public health and Consultant Cardiologist at Imperial College London, commented:

The cumulative effects of long-term uncontrolled LDL-C continue to place millions of people at increased cardiovascular risk. The results of the ORION-11 trial support the unprecedented potential of inclisiran to deliver assurance to clinicians and patients that LDL-C can be lowered in a sustained fashion over the long-term with an infrequent dosing regimen and an excellent safety profile. This is a groundbreaking new approach for preventing atherosclerotic cardiovascular disease with exciting implications at a population health level.

Shares of Medicines Co. were last seen up about 5% at $44.12, in a 52-week range of $16.69 to $47.50. The consensus price target is $60.07.
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About the Author Chris Lange →

Chris Lange is a writer for 24/7 Wall St., based in Houston. He has covered financial markets over the past decade with an emphasis on healthcare, tech, and IPOs. During this time, he has published thousands of articles with insightful analysis across these complex fields. Currently, Lange's focus is on military and geopolitical topics.

Lange's work has been quoted or mentioned in Forbes, The New York Times, Business Insider, USA Today, MSN, Yahoo, The Verge, Vice, The Intelligencer, Quartz, Nasdaq, The Motley Fool, Fox Business, International Business Times, The Street, Seeking Alpha, Barron’s, Benzinga, and many other major publications.

A graduate of Southwestern University in Georgetown, Texas, Lange majored in business with a particular focus on investments. He has previous experience in the banking industry and startups.