Biotech Values

[DewDiligence]

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.