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Re: CT post# 223066

Monday, 01/07/2019 3:59:31 PM

Monday, January 07, 2019 3:59:31 PM

Post# of 251933
Re: ENTA phase-2a in NASH

There are 125 patients, and the primary endpoint is ALT change from baseline. There is no post-treatment biopsy, but a pre-treatment biopsy (in addition to an elevated ALT reading and an MRI-PDFF showing ≥8% steatosis) is required to establish NASH for patients who are not diabetic or pre-diabetic.

The clinicaltrials.gov listing (https://www.clinicaltrials.gov/ct2/show/NCT03421431 ) says primary-endpoint results are expected in Mar 2019, but this date is apparently wrong, based on ENTA’s PR today.

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