New Publication Highlights Therapeutic Potential of Endogenous Metabolic Modulators (EMMs)
iScience review paper details use of amino acids in medicine
Axcella focused on designing novel EMM compositions with the potential to tackle complex diseases; plans to advance lead candidates into later-stage clinical trials
Amino acids and related metabolites and precursors are a class of EMMs that have diverse biological functions. Entitled “Endogenous Metabolic Modulators: Emerging Therapeutic Potential of Amino Acids,” the new publication reviews literature on the use of this EMM class to treat diseases, with a focus on single and combination agents targeted to a single biology.
“This manuscript sheds light on a wealth of clinical precedents demonstrating the ability to utilize single and simple combinations of EMMs to reprogram biological pathways,” said
Complex diseases, which tend to involve the dysregulation of a variety of underlying pathways and biologies, also are discussed in the publication. These diseases would be best addressed by safe multifactorial treatments rather than combination therapies that can raise the risk of drug-drug interactions and adverse effects.
Axcella’s EMM compositions are designed to enable a comprehensive approach, with the potential to simultaneously and safely target multiple pathways underlying diseases and regulate biological processes to foster overall health.
“Individual EMMs have been utilized for decades to drive therapeutic activity with a well-established safety track record,” said
About Endogenous Metabolic Modulators (EMMs)
EMMs are a broad family of molecules, including amino acids, that regulate human metabolism. Axcella is developing a range of novel product candidates that are comprised of multiple EMMs engineered in distinct combinations and ratios to simultaneously impact multiple metabolic pathways to modify the root causes of various complex diseases and improve health.
About Axcella’s Clinical Approach
Each of the company’s clinical studies to date are or have been conducted as non-investigational new drug application (IND) clinical studies under
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Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases and improve health using endogenous metabolic modulator (EMM) compositions. The company’s product candidates are comprised of EMMs and their derivatives that are engineered in distinct combinations and ratios to simultaneously impact multiple biological pathways. Axcella’s pipeline includes lead therapeutic candidates for non-alcoholic steatohepatitis (NASH) and the reduction in risk of overt hepatic encephalopathy (OHE) recurrence. Additional muscle- and blood-related programs are in earlier-stage development. For more information, please visit www.axcellahealth.com.
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 characteristics and development potential of the company’s EMM product candidates, as well as compositions of EMMs in general, the company’s characterization of the results from its clinical studies and future clinical trials, and the potential of the company’s product candidates to impact health and/or treat disease, including NASH and OHE. 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 potential impact of COVID-19 on the company’s ability to conduct and complete its ongoing or planned clinical studies and IND-enabled clinical trials in a timely manner or at all due to patient or principal investigator recruitment or availability challenges, clinical trial site shutdowns or other interruptions and potential limitations on the quality, completeness and interpretability of data the company is able to collect in its clinical studies or IND-enabled clinical trials, other potential impacts of COVID-19 on business and financial results, including with respect to the ability to raise additional capital, make planned interactions and submissions to FDA or other regulatory authorities in a timely manner or at all and operational disruptions or delays, changes in law, regulations, or interpretations and enforcement of regulatory guidance, whether data readouts and/or FDA feedback support the company’s IND submissions and clinical trial initiation plans and timing, whether and when, if at all, the company’s product candidates will receive approval from the FDA or other comparable regulatory authorities, and for which, if any, indications, past results from clinical studies not being representative of future results, and other risks identified in the company’s