Axcella Announces Presentations at the American Association for the Study of Liver Disease (AASLD) The Liver Meeting
AXA1665, Axcella’s lead AXA candidate for the treatment of hepatic encephalopathy (HE), currently in a Non-IND, IRB-Approved Clinical Study in subjects with mild-moderate hepatic insufficiency, is a novel composition of endogenous metabolic modulators designed to target multiple metabolic pathways intersecting key organ systems, including liver, muscle and gut that play key roles in liver health. AXA1125, currently in a Non-IND, IRB-Approved Clinical Study in adult subjects with non-alcoholic fatty liver disease (NAFLD), is a novel composition of EMMs designed to simultaneously support metabolic, inflammatory and fibrotic pathways associated with liver health.
Abstracts to be presented:
Abstract Number/Title: #0432 AXA1665, A defined composition of endogenous metabolic modulators, but not dietary protein improved the dysregulated amino acid metabolism and ammonia disposal in Child-Pugh A and B subjects
Abstract Number/Title: #2134 AXA1125, Mechanistic insights into the multimodal effects of AXA1125 inT2D Subjects with NAFLD
About Endogenous Metabolic Modulators
Endogenous metabolic modulators, or EMMs, are a broad family of molecules, including amino acids, which fundamentally impact and regulate human metabolism. Our AXA Candidates are anchored by EMMs that have a history of safe use as food. We believe that, unlike conventional targeted interventions currently used to address dysregulated metabolism, EMM compositions have the potential to directly and simultaneously support and modulate multiple metabolic pathways implicated both in complex diseases and overall health.
About Non-IND, IRB-Approved Clinical Studies
Axcella conducts non-investigational new drug application (Non-IND),
Axcella is designing and developing AXA Candidates, compositions of endogenous metabolic modulators, or EMMs, engineered in distinct ratios, designed to target and maximize the fundamental role that EMMs play in regulating multiple metabolic functions. Axcella’s AXA Candidates are generated from its proprietary, human-focused AXA Development Platform. Axcella believes its expertise and capabilities in EMMs position it to become a preeminent biotechnology company reprogramming metabolism to address a diverse set of complex diseases and support health. Axcella’s AXA Development Platform has already produced a pipeline of product candidates in programs targeting liver, muscle and blood. Axcella was founded by Flagship Pioneering. For more information, visit www.axcellahealth.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the development potential of our AXA Candidates, including AXA1665 and AXA1125, potential expansion into new therapeutic fields, the ability of endogenous metabolic modulators to impact dysregulated metabolism and health and the timing of our clinical studies and the timing of receipt of data from the same. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to the breadth of our pipeline of product candidates, the strength of our AXA Development Platform, the efficiency of our discovery and development approach, the clinical development and safety profile of our AXA Candidates and their health or therapeutic potential, whether and when, if at all, our AXA Candidates will receive approval from the
Caroline Rufo, Ph.D