Axcella Provides Progress Updates for Liver Program Candidates AXA1125 and AXA1957
- Completed enrollment in AXA1125 and AXA1957 study in adults with NAFLD
- Initiated enrollment of AXA1957 study in adolescents with NAFLD
- Developing AXA1125 and AXA1957 as therapeutic agents for NASH
AXA1125 and AXA1957 are novel compositions of endogenous metabolic modulators (EMMs) designed to simultaneously support metabolic, inflammatory and fibrotic pathways associated with liver health. Axcella has completed enrollment in a 16-week, randomized, placebo-controlled, Non-IND, IRB-Approved Clinical Study to assess safety, tolerability and physiological impact of AXA1125 and AXA1957 on structures and functions in approximately 105 adult subjects with Non-Alcoholic Fatty Liver Disease (NAFLD). The Company currently anticipates the data readout from this study in the second half of 2020.
“NAFLD is one of, if not the most common chronic liver diseases we face today. The more aggressive component of NAFLD, non-alcoholic steatohepatitis (NASH), is found in up to 25% of these patients and can progress to cirrhosis, liver decompensation and hepatocellular carcinoma,” said
Additionally, in the third quarter of 2019 Axcella initiated a placebo-controlled, randomized, Non-IND, IRB Approved Clinical Study to assess safety, tolerability and physiological impact of AXA1957 on structures and functions in adolescent subjects with NAFLD. The Company anticipates the data readout from this study in the second half of 2020.
“Fatty liver in obese children is becoming a huge public health burden given its strong association with type 2 diabetes, future cardiovascular risk and many other complications,” said Professor
Given the significant unmet need, the data generated to date and the potential of multifactorial interventions such as EMMs in liver disease, Axcella will be developing AXA1125 and AXA1957 as therapeutic candidates in NASH under an IND.
“I am delighted that we have achieved these important milestones including completing enrollment in our adult study and initiating our pediatric program,” commented
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, IRB-Approved Clinical Studies
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.
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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 AXA1125, AXA1957 and AXA1665, 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