- PSI-7851 was generally safe and well tolerated in Phase 1a single ascending dose trial
Perhaps I'm reading too much into this, but I'm a little skeptical of the use of the word "generally" here. Although they later indicate in the release that there were no adverse events, among other things, I wonder if the use of "generally" implies there may have been other potential safety signals noted in the trial that just didn't arise to a level of signficance due to the fact that this was such a short duration trial.
An additional presentation on IDX184 detailed results of the double-blind, placebo-controlled, single dose-escalation study that evaluated the safety and pharmacokinetics of IDX184 in healthy volunteers. Eight subjects (randomized 6:2, active:placebo) in each dosing cohort were administered a single dose of IDX184, ranging from 5 mg to 100 mg, or placebo. IDX184 was safe and well-tolerated in this study; the most common adverse event reported was dizziness and it was more frequently reported in subjects receiving placebo. In this study, the pharmacokinetics of IDX184 and the nucleoside metabolite were consistent with a liver-targeted drug. Systemic exposures and plasma half-life of the nucleoside metabolite were similar to that of its active triphosphate measured in vitro in human hepatocytes. In this healthy volunteer study, IDX184 doses of 50 mg/day and higher led to serum NM levels greater than 2 ng/mL 24 hours post-dose.
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