NASH Drug Development Guidance Encourages Sponsors To Adopt Innovative Trial Designs
Executive SummaryAlthough guidance appears to be free of surprises, US FDA once again made a push for sponsors to adopt seamless trial designs.
You may also be interested in...
None of the two-drug combinations tested by Gilead met statistical significance in the multi-arm non-alcoholic steatohepatitis trial. This follows the Phase III failure of selonsertib monotherapy earlier in 2019.
Patient-reported outcomes indicate patients don’t see itch as a major quality-of-life factor. Intercept also reports that adding earlier-stage patients to review of OCA shows better data on resolving NASH.
Genfit believes elafibranor’s clean tolerability and safety profile may help narrow the gap between it and Intercept’s OCA, with safety questions delaying OCA’s entry to market. Part two of Scrip’s interview with Genfit’s CEO and COO.