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

Health and Healthcare

Published: September 3, 2019 10:50 am

Last Updated: January 30, 2020 4:42 pm

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.

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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