Biotech Values

[DewDiligence]

Imaging endpoints for NASH are being tested—but it’s too soon to say which ones will make the cut:

https://www.biocentury.com/biocentury/product-development/2017-04-14/new-nash-data-show-companies-testing-non-invasive-imaging-

Data on mid-stage NASH candidates to be presented at the…International Liver Congress this month…raise the possibility that, before long, imaging-based endpoints could replace biopsies in clinical trials.

In abstracts released ahead of the International Liver Congress, NGM Biopharmaceuticals Inc., Bristol-Myers Squibb Co. and Gilead Sciences Inc. reported Phase II data demonstrating their non-alcoholic steatohepatitis (NASH) agents led to reductions in liver fat content measured by MRI-proton density fat fraction (MRI-PDFF).

BMS and Gilead also showed reductions in liver stiffness, a measure of fibrosis, as determined by magnetic resonance elastography (MRE).

The imaging-based endpoints are not yet validated, and do not permit comparison with Phase III compounds that have used only the biopsy-based histological endpoints required by FDA and EMA for approval.

…But imaging-based endpoints have the potential to provide more accurate data, as well as reduce burden and risks to patients. As a result, many companies working in NASH are incorporating both imaging and biopsy in ongoing and planned studies.

Please see #msg-129038646 for related discussion.