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DewDiligence

04/19/17 11:39 AM

#210711 RE: DewDiligence #210461

ENTA—A little more detail re phase-1 trial of EDP-305:

http://finance.yahoo.com/news/enanta-announces-preclinical-data-fxr-102800794.html

EDP-305 is currently in Phase 1 clinical development. Enanta’s ongoing double-blind, placebo-controlled Phase 1a/b study is designed to evaluate the safety, tolerability and pharmacokinetics of single ascending doses (SAD) and multiple ascending doses (MAD) of EDP-305 in healthy adults, and in adults with presumptive non-alcoholic fatty liver disease (NAFLD) (obese, with or without pre-diabetes or type 2 diabetes). The study will enroll approximately 150 subjects and is planned to evaluate at least 5 single and multiple dose cohorts, with EDP-305 administered orally, once daily.

I.e. the phase-1a part of the study is in healthy volunteers, and the phase-1b part of the study is in (presumptive) NAFLD patients.