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, the panel continues exploring oral drugs (specifically PXL-065) before reviewing positive interim data from the Phase 2b EMMPACT study by Axcella.

Promising Interim Data from Axcella’s Phase 2B EMMPACT Study

Roger Green notes that introducing multiple modes of action to the market will create the energy and investment to drive a dynamic explosion of education and exploration in Fatty Liver diseases. Stephen Harrison adds final thoughts on why PXL-065 may be a good choice in combination and/or long-term maintenance therapy. The discussion shifts to Axcella’s EMMPACT study, an ongoing global Phase 2b randomized, double-blind, placebo-controlled, dose ranging study to evaluate the safety, tolerability, and efficacy of AXA1125 for the treatment of NASH. The dose form comes in a unique liquid comparable to Tang drink mix. Stephen elucidates on the science behind using multi-targeted endogenous metabolic modulator (EMM) compositions. He presents the pre-planned interim analysis which offers promising findings regarding the effects of AXA1125 administration on selected outcome measures after 12- and 24-weeks of treatment. As the conversation ends, he contextualizes the results and comments on the broad activity of this drug in addition to its well-tolerated profile and safety.