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     424  0 Kommentare Alnylam Pharmaceuticals Provides Perspective on Positive Complete Results from ORION-11 Phase 3 Study of Inclisiran

    Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today provided perspective on the positive complete results from the ORION-11 Phase 3 study of inclisiran, an RNAi therapeutic in development for the treatment of hypercholesterolemia. These results were presented earlier today by Alnylam’s partner The Medicines Company and collaborators at the European Society of Cardiology’s ESC Congress 2019 in Paris, France.

    “The ORION-11 results represent a landmark event for Alnylam and RNAi therapeutics. With over 1,600 patients enrolled, ORION-11 is the largest ever randomized, double-blind, placebo-controlled study of any RNA-based medicine. The results from the study demonstrate significant efficacy for a drug administered subcutaneously once every six months and a very encouraging safety profile, with predominantly mild and transient injection site reactions as the only reported drug-related finding,” said John Maraganore, Ph.D., Chief Executive Officer of Alnylam. “These results further support the safety of our RNAi therapeutics platform and provide the largest demonstration to date suggesting that there is no systematic evidence for a platform-specific safety signal. Consequently, these results greatly strengthen our conviction for the future potential of RNAi therapeutics in large population diseases. Moreover, the pharmacology of RNAi therapeutics, as infrequently administered medicines, creates what we believe to be a very attractive profile for the treatment of common diseases. Finally, assuming a positive regulatory review, the significant inclisiran royalties of up to 20 percent will provide yet another source of relatively near-term revenues and will support Alnylam’s transition toward a self-sustainable financial profile for continued and future growth.”

    ORION-11 now becomes the third positive Phase 3 study for an RNAi therapeutic and the second in 2019 alone. Assuming ORION-9 and -10 are similarly positive and following regulatory submissions and review, Alnylam expects inclisiran could reach the market around late 2020.

    A video of Dr. Maraganore commenting on the implications of the ORION-11 results can be viewed on the Company’s website, www.alnylam.com.

    About Inclisiran

    Inclisiran, the first cholesterol-lowering therapy in the RNAi therapeutics class, is an investigational therapy in Phase 3 clinical development to evaluate its ability to lower low-density lipoprotein cholesterol (also known as LDL-C) through twice-yearly dosing. Inclisiran harnesses 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 Phase 2 studies, inclisiran provided clinically significant LDL-C reductions greater than 50 percent in addition to the effects of statins and/or ezetimibe, and LDL-C reductions were sustained throughout the six-month dosing interval. The safety and efficacy of inclisiran were evaluated in the ORION-11 Phase 3 study with positive results; these results have not been evaluated by the FDA, the EMA or any other health authority. Inclisiran is not yet approved for use by the FDA or any other regulatory authority. In February 2013 Alnylam granted global rights under a license and collaboration agreement to The Medicines Company to develop, manufacture, and commercialize inclisiran.

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    Alnylam Pharmaceuticals Provides Perspective on Positive Complete Results from ORION-11 Phase 3 Study of Inclisiran Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today provided perspective on the positive complete results from the ORION-11 Phase 3 study of inclisiran, an RNAi therapeutic in development for the treatment of …

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