Cardiovascular disease focused biopharmaceutical company The Medicines Company (MDCO:NASDAQ) today announced positive topline results for the ORION-9 Phase 3 clinical study in patients with Heterozygous Familial Hypercholesterolemia (HeFH). The firm advised that the ORION-9 study met all primary and secondary endpoints, and inclisiran demonstrated "durable and potent efficacy and was well tolerated with excellent safety that was generally well balanced between the treatment groups," and further noted that there were no treatment-related liver or renal laboratory abnormalities.
The company indicated that that detailed efficacy, tolerability and safety data from ORION-9 will be presented at the American Heart Association (AHA) Scientific Sessions in Philadelphia on November 18, 2019. Regulatory submissions for inclisiran are anticipated to occur in the U.S. in Q4/19 and in Europe in Q1/20.
The company's CEO Mark Timney commented, "The devastating cumulative effects of high LDL-C are more pronounced in people with FH, many of whom do not reach their treatment goals despite having significantly increased risk of cardiovascular disease...The results of ORION-9 strongly support inclisiran's potential in this patient population where the disease severity is highest."
The firm explains that FH is an inherited condition that causes high levels of LDL-C and leads to early onset of heart disease. Approximately 1.3 million people in the U.S. have FH, but a large percentage have not been properly diagnosed. HeFH is the most common form of FH. Homozygous FH (HoFH) is the most severe, much rarer form, which causes extremely high LDL-C, resulting in aggressive heart disease at a very young age.
Peter Wijngaard, Ph.D., chief development officer of The Medicines Company, added, "It is particularly gratifying to see a successful outcome in a patient population where baseline LDL-C levels are significantly higher and unmet needs are so profound."
The company claims that inclisiran is the "first and only cholesterol-lowering therapy in the siRNA (small-interfering RNA) class" developed to "reduce low-density lipoprotein cholesterol (LDL-C)." As a siRNA, inclisiran is said to harness "the body's natural process of RNA interference to specifically prevent production of the PCSK9 protein in the liver which enhances the liver's ability to remove LDL-C from the bloodstream, thereby lowering LDL-C levels."
In a separate release this morning, The Medicines Company also announced positive topline results for the ORION-10 Phase 3 clinical study in patients with atherosclerotic cardiovascular disease (ASCVD), successfully completing the pivotal Phase 3 LDL-cholesterol (LDL-C) lowering clinical trials for inclisiran. The firm reported that ORION-10 met all primary and secondary endpoints, and inclisiran demonstrated efficacy, tolerability and safety that were at least as favorable as observed in ORION-11, with no treatment-related liver or renal laboratory abnormalities.
The company advised that detailed efficacy, tolerability and safety data from ORION-10 will be presented at the American Heart Association (AHA) Scientific Sessions in Philadelphia on Saturday, November 16, 2019.
CEO Mark Timney commented, "The results seen in ORION-10 again demonstrate inclisiran's outstanding efficacy, tolerability and safety...This is further validation of the potential of this first and only investigational cholesterol-lowering therapy in the siRNA class to transform the treatment of cardiovascular disease for millions of people with ASCVD."
The ORION program is studying the efficacy and safety of inclisiran in patients with ASCVD and FH, with ORION-9, ORION-10 and ORION-11 comprising the pivotal Phase 3 LDL-C lowering studies.
Peter Wijngaard added, "Seeing such consistent results across the breadth of our clinical development program in patients treated with inclisiran for up to 3 years, including 18 months in pivotal Phase 3 studies, is truly impressive."
The Medicines Company is headquartered in Parsippany, NJ and states that it is a global biopharmaceutical company with a singular, relentless focus on addressing the greatest global healthcare challenge today which it identifies to be cardiovascular disease. The firm indicates that its purpose is to halt the deadly progression of atherosclerosis and the cardiovascular risk created by high levels of LDL-C.
The Medicines Company began the day with a market capitalization of $3.7 billion and as of Tuesday had a short interest of around 29%. MDCO shares opened higher today at $49.42 (+$2.28, +4.84%) over yesterday's $47.14 closing price. The stock has traded today between $49.25 and $51.93/share and presently is trading at $51.11 (+$3.97, +8.42%).
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