CAMBRIDGE, Mass.--(BUSINESS WIRE)--Axcella Health (Nasdaq: AXLA), a biotechnology company pioneering the research and development of novel interventions to address dysregulated metabolism and support health, today announced that it will present new data on the companys liver product candidates at The Liver MeetingTM, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), being held this week in Boston. Two poster presentations highlight mechanistic data from preclinical and non-IND clinical studies of two of its investigational candidates, AXA1665 and AXA1125.

Simultaneous dysregulation in multiple pathways is a fundamental feature of complex diseases such as hepatic encephalopathy (HE) and nonalcoholic steatohepatitis (NASH), explains Dr. Manu Chakravarthy, M.D., Ph.D., Axcellas SVP of Clinical Development and Chief Medical Officer. In order to effectively address these conditions, a safe, multifactorial approach is required. We are excited to share our latest clinical findings, which both affirm and deepen our mechanistic understanding of the ways in which AXA1665 and AXA1125 may impact key biochemical and molecular pathways.

Poster #0432 showcases the distinctive pharmacokinetic profile of AXA1665, as compared to a standard protein supplement, with improved nitrogen and ammonia handling by AXA1665 in subjects with hepatic insufficiency.

Poster #2134 further delineates mechanisms underlying the previously reported observations of AXA1125 from a non-IND clinical study.

Further information is contained in the aforementioned posters at AASLD:

Abstract Number: #0432Title: 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 subjectsPresentation Type: PosterSession Date/Time: November 8, from 8:00 a.m. to 10:00 a.m. ETLocation: Hynes Convention Center, Hall B

Abstract Number: #2134Title: Mechanistic insights into the multimodal effects of AXA1125 in T2D subjects with NAFLDPresentation Type: PosterSession Date/Time: November 10, from 8:00 a.m. to 10:00 a.m. ETLocation: Hynes Convention Center, Hall B

About Endogenous Metabolic Modulators

Endogenous metabolic modulators (EMMs) are a broad family of molecules, including amino acids, which fundamentally impact and regulate human metabolism. Our AXA Candidates are comprised of EMMs that individually 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 modulate multiple metabolic pathways implicated both in complex diseases and overall health.

About Non-IND Clinical Studies

Axcella conducts Institutional Review Board (IRB)-approved, non-investigational new drug application (Non-IND) clinical studies in humans with its AXA Candidates under U.S. Food and Drug Administration regulations and guidance supporting research with food. 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 Candidates 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.

Internet Posting of Information

Axcella uses its website, http://www.axcellahealth.com, as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Such disclosures will be included on the companys website in the Investors and News section. Accordingly, investors should monitor such portions of the companys website, in addition to following its press releases, SEC filings and public conference calls and webcasts.

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. Axcellas 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. Axcellas 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 http://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 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 the companys 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 managements 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 the companys pipeline of product candidates, the strength of the AXA Development Platform, the efficiency of the companys discovery and development approach, the clinical development and safety profile of AXA Candidates and their health or therapeutic potential, whether and when, if at all, AXA Candidates will receive approval from the U.S. Food and Drug Administration and for which, if any, indications, competition from other biotechnology companies, the companys liquidity, its ability to successfully develop 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 the companys SEC filings, including Axcellas Quarterly Report on Form 10-Q and subsequent filings with the SEC. The company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Axcella disclaims 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 the companys views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. The company explicitly disclaims any obligation to update any forward-looking statements.

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Axcella Presents Data at The Liver Meeting Providing New Mechanistic Insights on Observed Multifactorial Effects of its Liver Product Candidates -...