A recent string of press releases presaged some of the most exciting, promising data of the last decade in NASH drug development. In this conversation, Principal Investigator Stephen Harrison reviews Phase 2b results from Akero’s HARMONY Trial. Special guest Mazen Noureddin joins Jörn Schattenberg, Louise Campbell and Roger Green to share impressions.

Phase 2B ‘Wow!’ Results from Akero’s HARMONY Trial

This conversation starts with Stephen returning to his discussion of Altimmune’s dual GLP-1/glucagon agonist, pemvidutide. He comments that stock analysts appear to have punished Altimmune because pemvidutide did not demonstrate greater weight loss. He considers this an inaccurate read. He notes that the 12 week weight loss results of pemvidutide are comparable with 24 weeks with efruxifermin (EFX) in the extremely successful HARMONY Trial. Stephen then segues to detail HARMONY, a 24-week study evaluating the efficacy and safety of the FGF-21 agonist EFX in patients with clinically relevant NASH (F2-F3). The topline results:

• The study met its primary endpoint for both the 50mg and 28mg EFX dose groups.
• Respectively, 41% and 39% of EFX-treated patients experienced at least a one-stage improvement in liver fibrosis with no worsening of NASH by week 24 (compared with 20% for the placebo arm).

Stephen notes the presence of key secondary endpoints and important demographics of the patients. He also describes the program for histological analysis and goes on to highlight some extremely positive – perhaps eye-opening – results. Mazen and Jörn react by describing these two results as a Wow! episode. Louise adds comments on the potential for the NIT analysis to speed the transition beyond the biopsy.