IDIX – Just to be clear: the FDA-imposed limit of 3 days for monotherapy testing of any new HCV agent did not exist when NM283 was at that stage of development.
I don’t think anything other than safety can be ascertained from 3-day monotherapy studies. The only purpose of these studies is to satisfy the FDA’s fear of some horrible outcome and thereby enable the drug in question to proceed to combination testing with interferon and ribavirin.
The science underlying IDX-184’s design appears to be sound: i.e. using a prodrug of the monophosphate nucleotide to obviate the need for the first phosphorylation step to be performed in vivo. The most intriguing revelation from today’s CC, IMO, was that ribavirin can compete with a nucleoside analog during the first phosphorylation step, and hence eliminating this step in vivo can allow the nuke to perform better when given with ribavirin.
JP Sommadossi had previously stated that IDX184 was synergistic with ribavirin, but today was the first time the rationale for this synergy was explained to investors.
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