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Axcella Announces Presentations at the American Association for the Study of Liver Disease (AASLD) The Liver Meeting

October 1, 2019 Off By BusinessWire

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Axcella Health Inc. (Nasdaq: AXLA), a biotechnology company pioneering the research and development of novel multifactorial interventions to address dysregulated metabolism and support health, today announced that the company will present two posters for two of its liver health-focused AXA candidates, AXA1665 and AXA1125 at the American Association for the Study of Liver Disease (AASLD) conference taking place November 8 – 12, 2019 in Boston, MA. The continued selection of abstracts at major international conferences represents Axcella’s progress in developing endogenous metabolic modulators (EMMs).

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

Location: Hynes Convention Center, Hall B

Abstract Number/Title: #2134 AXA1125, Mechanistic insights into the multimodal effects of AXA1125 inT2D Subjects with NAFLD

Location: Hynes Convention Center, Hall B

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), Institutional Review Board (IRB)-approved clinical studies in humans with its AXA Candidates under U.S. Food and Drug Administration regulations and guidance supporting research with food outside of an IND. In these studies, Axcella evaluates in humans, including in individuals with disease, AXA Candidates for safety, tolerability and effects on the normal structures and functions of the body. Non-IND, IRB-Approved Clinical Studies are not designed or intended to evaluate an AXA Candidate’s ability to diagnose, cure, mitigate, treat or prevent a disease. If Axcella decides to further develop an AXA Candidate as a potential therapeutic, subsequent studies will be conducted under an IND.

About Axcella Health

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 U.S. Food and Drug Administration and for which, if any, indications, competition from other biotechnology companies, our liquidity, our ability to successfully develop our AXA Candidates through current and future milestones on the anticipated timeline, if at all, past results from Non-IND, IRB-Approved Clinical Studies not being representative of future results, and other risks identified in our SEC filings, including our Quarterly Report on Form 10-Q and subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.