Medicines Company announced interim results Saturday from the ongoing Phase 2 ORION-3 study that is evaluating the efficacy, safety and tolerability of inclisiran 300 mg in patients with atherosclerotic cardiovascular disease and elevated LDL cholesterol.
The results show a consistent lowering of LDL cholesterol by more than 50 percent, with an overall follow-up of up to three years.
The candidate was well-tolerated, with no material safety issues observed, the company said.
The results were presented as a late-breaking presentation at the National Lipid Association Scientific Sessions in Miami.
The 290 patients evaluated in the Group 1 cohort of the ORION-3 study for which the results were released received twice-a-year injections of inclisiran sodium 300 mg.
Inclisiran is the first cholesterol-lowering therapy in the siRNA class and it is also being evaluated in a Phase 3 clinical trial to evaluate its ability to lower LDL cholesterol with twice-a-year dosing.
"These new results reinforce that the potent, durable and consistent LDL-lowering effects of inclisiran continue over the long term with twice-a-year dosing that we believe can address the challenges of treatment adherence through improved therapeutic coverage and persistence," Peter Wijngaard, Medicines Company's chief development officer, said in a statement.
The Group 2 cohort of the ORION 3 study is being evaluated for the safety and efficacy of switching over from Amgen, Inc. (NASDAQ: AMGN)'s Repatha. The completion of the study is expected in 2022.
Medicines Company said it expects to release readouts from the pivotal Phase 3 study in the third quarter followed by a potential regulatory filing in the U.S. in the fourth quarter and in Europe by the first quarter of 2020.
Medicines Company shares were trading higher by 5.43 percent at the time of publication Monday, while Amgen was down 0.81 percent.
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