Blog Coverage Medicines Co. Reaches Agreement with FDA for the Phase III Trial for Inclisiran

LONDON, UK / ACCESSWIRE / April 27, 2017 / Active Wall St. blog coverage looks at the headline from The Medicines Co. (NASDAQ: MDCO) and Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY). On April 26, 2017, Medicines Co. (“MDCO”) and Alnylam Pharma announced that MDCO has received final, End-of-Phase II meeting minutes from the US Food and Drug Administration (FDA). MDCO has agreed with the FDA regarding plans for the Phase III clinical program for Inclisiran, designed to support the submission of a New Drug Application (NDA). Register with us now for your free membership and blog access at:

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What is Inclisiran?

Inclisiran, which was previously known as PCSK9si and ALN-PCSsc is an investigational GalNAc-conjugated RNAi therapeutic targeting PCSK9 – a genetically validated protein regulator of LDL receptor metabolism. This is being developed for the treatment of hypercholesterolemia. In contrast to anti-PCSK9 monoclonal antibodies that bind to PCSK9 in blood, Inclisiran is a first-in-class investigational medicine that acts by turning off PCSK9 synthesis in the liver.

Design of Phase III Program

MDCO’s Phase III program will comprise clinical trials in subjects with atherosclerotic cardiovascular disease (ASCVD) and familial hypercholesterolemia (FH). The Company will collectively enroll approximately 3,000 subjects randomized to treatment with Inclisiran (1,500) or placebo (1,500). The primary endpoint for all pivotal trials will be LDL-C change from baseline. MDCO stated that the subjects will be studied for 18 months. The dose of Inclisiran will be 300 mg given subcutaneously on day-1, day-90, and then every six months thereafter.

MDCO will also perform a cardiovascular outcomes trial in approximately 14,000 subjects with ASCVD and/or risk equivalents, such as diabetes, to determine the effects of LDL-C lowering with Inclisiran on cardiovascular outcomes. The design of the outcomes trial has also been agreed with the FDA and the primary efficacy endpoint of the trial will be a composite of coronary heart disease death, non-fatal myocardial infarction and fatal and non-fatal ischemic stroke. MDCO noted that the duration of the outcomes trial will be long enough to accumulate a sufficient number of events to provide overwhelming statistical power to ascertain treatment group differences and maximize the clinical effect size associated with LDL-C lowering. If the results exceed the primary end point target, the outcomes trial will be submitted to the FDA as a supplemental NDA.

“We are grateful to the FDA for its expertise, advice and support. Cardiovascular disease is a serious threat to the health of Americans, and it is clear that the FDA is committed to facilitating the development and approval of effective and safe drugs to address this important public health problem,” said Clive Meanwell, M.D., Ph.D., CEO of The Medicines Company, “Based on data from our Phase II ORION-1 study and the previous Phase I study – both published in The New England Journal of Medicine – we are confident that Inclisiran reduces LDL-C meaningfully. We believe our agreement with the FDA on the Phase III clinical development program for Inclisiran is highly favorable and adds significantly to Inclisiran’s strategic value.”

“The Medicines Company’s agreement with the FDA supports a clear path forward for further Inclisiran development and regulatory review. Indeed, we’re pleased with the excellent progress made by our colleagues at The Medicines Company to advance this potential, innovative medicine to patients in need, and we intend to fully support them in their efforts,” said John M. Maraganore, Ph.D., Alnylam’s CEO.

MDCO and Alnylam Pharma have been collaborating in the advancement of Inclisiran pursuant to their 2013 agreement. Under terms of the agreement, Alnylam completed certain pre-clinical studies and the Phase I clinical study, with MDCO leading and funding the development of Inclisiran from Phase II forward, as well as potential commercialization.

Stock Performance

On Wednesday, April 26, 2017, the stock closed the trading session at $49.75, climbing 1.30% from its previous closing price of $49.11. A total volume of 3.18 million shares have exchanged hands, which was higher than the 3-month average volume of 2.01 million shares. Medicines Co.’s stock price rallied 43.00% in the last three months, 34.53% in the past six months, and 39.43% in the previous twelve months. Furthermore, on a year to date basis, the stock soared 46.58%. The stock currently has a market cap of $3.55 billion.

Alnylam Pharma’s share price finished yesterday’s trading session at $54.02, advancing 5.20%. A total volume of 808.19 thousand shares exchanged hands. The stock has surged 42.80% and 45.22% in the last three months and past six months, respectively. Furthermore, since the start of the year, shares of the Company have soared 44.28%. At Wednesday’s closing price, the stock’s net capitalization stands at $4.57 billion.

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