Home Health Care The Medicines Co. studies produce further encouraging data on RNAi cholesterol drug

The Medicines Co. studies produce further encouraging data on RNAi cholesterol drug

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The Medicines Company has bolstered previously announced positive data from a Phase III study of an RNA-interference drug that works against PCSK9 with announcements of top-line results from two additional trials.

The Parsippany, New Jersey-based company announced Wednesday top-line results from its Phase III ORION-9 study of inclisiran in heterozygous familial hypercholesterolemia (HeFH) and from the Phase III ORION-10 study in atherosclerotic cardiovascular disease (ASCVD). The drug, which the company is developing with Alnylam Pharmaceuticals, uses RNAi to prevent the liver’s production of PCSK9, thereby enhancing the organ’s ability to reduce LDL or “bad” cholesterol. The Medicines Company did not provide details of the data other than to say the results were positive, but said it would provide more detailed data at the American Heart Association Scientific Sessions, which takes place in Philadelphia in the middle of November.

Earlier this month, the company announced positive top-line data from another Phase III study, ORION-11, which was also in ASCVD. The company has said previously that it will begin regulatory filings in the U.S. in the fourth quarter of this year and in Europe during the first quarter of next year.

MedCo’s shares were up more than 8 percent on the Nasdaq following the news.

Two drugs that target PCSK9 are currently on the market: Repatha (evolocumab), made by Amgen, and Praluent (alirocumab), made by Sanofi and Regeneron Pharmaceuticals. However, they both differ from inclisiran in that they are monoclonal antibodies rather than RNAi drugs. Another difference is that whereas Repatha and Praluent are administered once every two to four weeks, inclisiran is administered only twice per year.

B. Riley FBR analyst Mayank Mamtani had written in a note to investors following the ORION-11 data release that the results of that study de-risked those of ORION-9 and ORION-10. In a note Wednesday in response to the announcements for the latter two trials, he wrote that pending the release of patient-level data, the latest results further validate inclisiran’s differentiated clinical profile. He also wrote that ORION-10 results indicate a safety profile “at least as favorable” as that of ORION-11.

Photo: manopjk, Getty Images

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