FDA issues IND application to Dicerna, Lilly for RNAi candidate

By The Science Advisory Board staff writers

November 16, 2020 -- Dicerna Pharmaceuticals' investigational new drug (IND) application for LY3561774, an RNA interference (RNAi) therapeutic, has been accepted by the U.S. Food and Drug Administration (FDA).

This is the first candidate to emerge from Dicerna's collaboration with Eli Lilly for RNAi therapeutics using Dicerna's proprietary RNAi technology platform, called GalXC. The IND milestone triggers a $10 million payment to Dicerna and enables Lilly to initiate a phase I clinical trial of the candidate, which is expected before the end of 2020, for the treatment of an undisclosed cardiometabolic disease.

The global licensing and research collaboration was formed in 2018 and is focused on the discovery, development, and commercialization of potential new therapies for cardiometabolic disease, neurodegeneration, and pain. Dicerna is eligible to receive up to $350 million in development and commercialization milestones for each GalXC hepatocyte target and $355 million for each nonhepatocyte target, as well as tiered royalties ranging from the mid-single digits to low double digits on potential product sales.

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