Enanta has announced that the Food and Drug Administration (FDA) has granted Fast Track designation to their drug candidate EDP-305, a farnesoid X receptor (FXR) agonist.
EDP-305 is intended to treat patients with non-alcoholic steatohepaitis (NASH) with liver fibrosis. The drug is currently in Phase 1 clinical development, which is aimed at evaluating the safety, tolerability and pharmacokinetics of single ascending doses and multiple ascending doses of EDP-305; the study will include approximately 90 individuals (healthy adults and adults with presumptive non-alcoholic fatty liver disease) and is planned to evaluate up to five dose cohorts.
EDP-305 is a potent FXR agonist and represents a new class that has been designed to take advantage of increased binding interactions with the receptor. Further, this non-bile acid class contains steroid and non-steroid components, and does not contain the carboxylic acid group normally present in other classes of FXR agonists and natural bile acids that can lead to the formation of taurine and glycine conjugates.
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