Alnylam Pharma provides perspective on positive results from ORION-11 Phase III Study of inclisiran.

Alnylam Pharmaceuticals, Inc. provided perspective on the positive complete results from the ORION-11 Phase III study of inclisiran, an RNAi therapeutic in development for the treatment of hypercholesterolemia. These results were presented earlier 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 III 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.