02 Sep, 2019 ORION-11 Phase 3 Results for Inclisiran Presented at ESC
Our partner The Medicines Company and collaborators presented positive complete results from the ORION-11 Phase 3 study of inclisiran, an RNAi therapeutic in development for the treatment of hypercholesterolemia, at the European Society of Cardiology’s ESC Congress 2019, held August 31 to September 4, 2019 in Paris, France.
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- In ORION-11, twice-yearly dosing with inclisiran sodium 300 mg met all primary and secondary efficacy endpoints, was well tolerated and demonstrated an excellent safety profile.
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- For the primary endpoints of ORION-11, inclisiran delivered placebo-adjusted LDL-C reductions of 54% at day 510 and demonstrated time-averaged placebo-adjusted LDL-C reductions of 50% from days 90 through 540.
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- The overall adverse event profiles of the placebo- and inclisiran-treated groups in ORION-11 were similar, with no imbalances of major adverse events, including liver enzyme or renal abnormalities, and with predominantly mild and transient injection site reactions as the only reported drug-related finding.
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ORION-11 now becomes the third positive Phase 3 study for an RNAi therapeutic and the second in 2019 alone. These results provide the largest demonstration to date suggesting that there is no systematic evidence for a platform-specific safety signal for our GalNAc-conjugated siRNAs, and greatly strengthen our conviction for the future potential of RNAi therapeutics in large population diseases. Assuming a positive regulatory review, the significant inclisiran royalties of up to 20% will provide yet another source of relatively near-term revenues and will support our transition toward a self-sustainable financial profile for continued and future growth.
