The Medicines Company MDCO gave a sneak-peek of results from a late-stage trial of its proprotein convertase subtilisin/kexin type 9,or PCSK9 inhibitor inclisiran Monday morning ahead of presentation as a late-breaking science session Sept. 2 at the European Society of Cardiology Congress 2019.
What Happened
The actively traded mid-cap biotech were solidly higher Monday after the company announced positive top-line results from the first pivotal Phase 3 study dubbed ORION-11 that evaluated inclisiran sodium 300mg. The study met all primary and secondary endpoints, with efficacy consistent with findings from the Phase 1 and Phase 2 studies, according to the company.
The placebo-controlled, double-blind, randomized study evaluated the safety, efficacy and tolerability of inclisiran sodium 300mg administered subcutaneously to 1,617 patients with atherosclerotic cardiovascular disease, or ASCVD, or ASCVD-risk equivalents and elevated low-density lipid - cholesterol, or LDL-C, despite the maximum tolerated dose of statin therapy.
Each study participant received 300mg of inclisiran administered as a subcutaneous injection initially; again at three months; and every six months thereafter.
The primary endpoints are:
- percentage change in LDL-C from baseline to day 510
- time-adjusted percentage change in LDL-C from baseline after day 90 and up to 540 months.
The secondary endpoints include mean absolute change at day 510, the average absolute reduction from day 90 up to day 540 and changes in other lipids and lipoproteins.
"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 company said in a statement.
Why It's Important
Medicines Co.'s product candidate inclisiran addresses two concerns in treating cardiovascular diseases: the inability of a majority of patients achieving LDL-C goals and poor adherence to current therapy.
The anti-PCSK9 lipid management market is valued at $23.6 billion in 2030, according to analysts.
What's Next
Medicines Co. is scheduled to present detailed results from the ORION-11 study at the ESC Congress. It also expects to submit data for publication in a peer-reviewed journal.
The company also said it expects top-line Phase 3 readouts from the ORION-9 and ORION-10 studies in the third quarter, ahead of regulatory submissions in the U.S. in the fourth quarter of 2019 and in Europe in the first quarter of 2020.
Patients completing the ORION-9, ORION-10 and ORION-11 studies are now enrolling in ORION-8, an open-label long-term extension study in which they will receive inclisiran for three years.
The release has helped the stock break above a long-term resistance around the $33-$35 area.
Medicines Co. shares were up 9.39% at $38.34 at the time of publication Monday.
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