Axcella在美国肝病研究协会（AASLD）肝脏会议上发表演讲

StephenW

Axcella Announces Presentations at the American Association for the Study of Liver Disease (AASLD) The Liver Meeting
October 01, 2019 04:11 PM Eastern Daylight Time

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.

StephenW

Axcella在美国肝病研究协会（AASLD）肝脏会议上发表演讲
十月01，2019 04:11 PM东部夏令时间

马萨诸塞州坎布里奇-（BUSINESS WIRE）-（美国商业资讯）-生物技术公司Axcella Health Inc.（纳斯达克股票代码：AXLA）率先研究和开发新型多因素干预措施，以解决代谢失调和支持健康的问题，今天宣布该公司将提出两项建议2019年11月8日至12日在美国马萨诸塞州波士顿举行的美国肝病研究协会（AASLD）会议上，其针对肝脏健康的两种AXA候选药物AXA1665和AXA1125的海报。在主要的国际会议上继续选择摘要代表了Axcella在开发内源性代谢调节剂（EMM）方面的进展。

AXC1665是Axcella治疗肝性脑病（HE）的主要AXA候选药物，目前正在非IND，IRB批准的针对轻度-中度肝功能不全的受试者的临床研究中，是一种旨在针对多种代谢的内源性代谢调节剂的新型组合物与重要器官系统相交的途径，包括肝脏，肌肉和肠道，它们在肝脏健康中起关键作用。 AXA1125，目前正在一项非IND，IRB批准的针对非酒精性脂肪肝疾病（NAFLD）的成年受试者的临床研究中，是一种新型的EMM，旨在模拟支持与肝脏健康相关的代谢，炎症和纤维化途径。

论文摘要：

摘要编号/标题：＃0432 AXA1665，一种确定的内源性代谢调节剂组成，但饮食蛋白不能改善Child-Pugh A和B受试者的氨基酸代谢失调和氨处置

地点：海因斯会议中心B厅

摘要编号/标题：＃2134 AXA1125，深入了解AXA1125在患有NAFLD的T2D受试者中的多峰效应的机理

地点：海因斯会议中心B厅

关于内源代谢调节剂

内源性代谢调节剂（EMM）是广泛的分子家族，包括氨基酸，从根本上影响和调节人类的新陈代谢。我们的AXA候选产品由具有安全使用食品历史的EMM定位。当前用于解决代谢失调的干预措施，EMM组合物具有直接和同时支持和调节与复杂疾病和整体健康有关的多种代谢途径的潜力。

关于未经IND，IRB批准的临床研究

Axcella根据美国食品和药物管理局的规定以及支持IND以外食品研究的指南，进行了非研究性新药申请（Non-IND），机构审查委员会（IRB）批准的AXA候选人体临床研究。研究表明，Axcella可在人类（包括患有疾病的个体）中评估AXA候选者的安全性，耐受性以及对人体正常结构和功能的影响。未经IND，IRB批准的非临床研究并非旨在或旨在评估AXA候选者的If Tox，治愈，治愈，治愈，治愈，治愈，治愈，治愈，治愈，治愈

关于Axcella Health

Axcella正在设计和开发AXA候选产品，即内源性代谢调节剂或EMM的组成，以不同的比例进行工程设计，旨在针对并最大化EMM在调节多种代谢功能中发挥的基本作用。 Axcella的AXA候选人源于其专有的人类。Axcella相信，其在EMM中的专业知识和能力使其成为一家出色的生物技术公司，可以对代谢进行重新编程，以解决多种复杂疾病并支持健康。 Axcella的AXA开发平台已经在针对肝脏，肌肉和血液的计划中生产了一系列候选产品。 Axcella由旗舰创业公司创立。有关更多信息，请访问www.axcellahealth.com。