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A recent string of press releases presaged some of the most exciting, promising data of the last decade in NASH drug development. This conversation explores the single unsuccessful trial result accompanying the spate of positive reports. Intercept’s REVERSE study focuses on evaluating the safety and efficacy of obeticholic acid (OCA) in patients with compensated cirrhosis. Stephen Harrison outlines the Phase 3 results which, ultimately, did not meet its primary endpoint. Stephen notes the analysis of the F3 REGENERATE trial continues and data from REVERSE may provide support for the REGENERATE safety story. 

Louise Campbell takes optimistic interest in this study. She notes, given a cirrhotic population, an F1 improvement may be a difficult, if not unrealistic endpoint. There is value in stabilizing disease. She suggests a focus on improving outcomes and quality of life and halting progression in this most at risk population.

Mazen Noureddin suggests this drug be reserved for combination therapy. Provided the positive data in the preceding press releases, the bar is now much higher. Roger Green adds that ultimately, the results are not statistically significant for this trial. 

Jörn Schattenberg is hopeful to glean learning beyond negative results. This is the largest cirrhosis study to date and it remains a challenge worthwhile to regress cirrhosis in compensated patients. 

The conversation concludes differently than any other previous Surfing the NASH Tsunami episode. Surf on to discover more.