Medicines Company's Inclisiran Succeeds in Pivotal Study
The Medicines Company MDCO announced that its PCSK9 inhibitor candidate, inclisiran, has met primary as well as secondary endpoints in a pivotal phase III study — ORION-11 — evaluating it for hypercholesterolemia. Moreover, the safety profile was similar to the profile achieved in phase II study (ORION-1) and an open-label extension study (ORION-3). Detailed data from the study will be presented at ESC Congress 2019 scheduled to be held on Sep 2.
In response to the development, shares of the company gained 13.8% on Aug 26. The company’s shares have surged 108.2% so far this year against the industry’s decline of 3.4%.
Please note that The Medicines Company and partner Alnylam Pharmaceuticals ALNY are evaluating inclisiran in several phase III ORION studies for treating patients with atherosclerotic cardiovascular disease (ASCVD) and elevated bad cholesterol (LDL-C).
The ORION-11 study evaluated twice-yearly dosing of inclisiran in patients with ASCVD and elevated LDL-C, following treatment with maximum tolerated dose of statin therapy alone or in combination with Merck’s MRK Zetia (ezetimibe). The primary endpoint of the study was percentage change in LDL-C levels from baseline after 17 months of treatment and time-adjusted percentage change in LDL-C from baseline after three and 18 months of treatment.
Data from the phase II study had shown that treatment with inclisiran reduced LDL-C levels by additional 50% over the levels achieved following treatment with statins alone or in combination with Zetia. Moreover, the reductions were sustained for six months.
The Medicines Company will announce top-line data from two other phase III studies — ORION-9 and ORION-10 — evaluating inclisiran in heterozygous familial hypercholesterolemia and ASCVD, respectively, by the end of September. Regulatory applications seeking approval for inclisiran are likely to be filed in the United States in the fourth quarter of 2019 and in Europe in the first quarter of 2020.
The company is also conducting an open-label, long-term extension study — ORION-8 — to evaluate inclisiran in patients who have completed the phase III studies over a period of three years.
We note that there are two marketed PCSK9 inhibitors — Sanofi/Regeneron’s Praluent and Amgen’s AMGN Repatha — for treating hypercholesterolemia. However, both the drugs need to be administered once every two weeks or four weeks while inclisiran is dosed twice a year. The lower need of administration may prove advantageous for the candidate. However, inclisiran is unlikely to be launched before 2021, which may lead to stiff competition from the approved drugs.
The Medicines Company Price
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The Medicines Company currently carries a Zacks Rank #4 (Sell).
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