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Poster presentations highlight AXA1125’s multifactorial activity; potentially differentiating and enhanced effects in subjects with type 2 diabetes
Axcella (Nasdaq: AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases and improve health using endogenous metabolic modulator (EMM) compositions, today shared details about the company’s poster presentations at The Liver Meeting® 2020, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which is taking place virtually today through November 16, 2020. Both presentations feature data from AXA1125-003, a placebo-controlled, randomized clinical study that enrolled 102 subjects with presumed nonalcoholic steatohepatitis (NASH) to assess the impact of AXA1125 and AXA1957 on safety, tolerability and effects on structures and functions of the liver for 16 weeks.
"The results of AXA1125-003 were a key milestone for Axcella in which we were able to demonstrate clinically relevant multifactorial effects with AXA1125 in subjects with presumed NASH," said Manu Chakravarthy, M.D., Ph.D., Axcella’s Chief Medical Officer and Executive Vice President of Clinical Development. "At The Liver Meeting this week, we are sharing further data from this study. Based on AXA1125’s data to date and its multi-targeted mechanism of action, we believe this candidate is well positioned to be a first-line NASH therapy with potentially differentiating effects in type 2 diabetic subjects. We look forward to investigating its impact on liver histology in our upcoming serial biopsy Phase 2b clinical trial in patients with biopsy-proven NASH."
Abstract 1663 is entitled "Biological Activity of AXA1125 and AXA1957 on Glucose, Insulin, HOMA-IR, and HbA1c and Measures of Liver Fat and Fibroinflammation in a Prospective 16-Week Randomized, Placebo-Controlled Study in Subjects with NAFLD and Type 2 Diabetes." This presentation highlights reductions seen in subjects receiving AXA1125 vs. placebo in markers of metabolism (MRI-PDFF and HOMA-IR) and fibroinflammation (cT1, ProC3 and FIB-4) as well as the reduction over time in ALT through 16 weeks. Additionally, the presentation shows the increased proportion of subjects receiving AXA1125 vs. placebo that achieved clinically relevant thresholds of improvement in specific markers, including:
Subjects on Placebo
Subjects on AXA1125
≥30% reduction in MRI-PDFF
≥17 U/L reduction in ALT
≥80 mSec reduction in cT1
≥2 ng/mL reduction in ProC3
Abstract 1694 is entitled "Safety, Tolerability, and Biological Activity of AXA1125 and AXA1957 in a Prospective 16-Week Randomized, Placebo-Controlled Study in Subjects with NAFLD with and without Type 2 Diabetes." Focusing on data for subjects with both presumed NASH and type 2 diabetes (T2D), the presentation highlights reductions seen in those receiving AXA1125 vs. placebo in measures of fasting glucose, fasting insulin, HOMA-IR, HbA1C, MRI-PDFF, ALT, cT1 and ProC3. It also features the increased proportion of these subjects that achieved clinically relevant thresholds of improvement in specific markers, including:
T2D Subjects on Placebo
T2D Subjects on AXA1125
≥30% reduction in MRI-PDFF
≥17 U/L reduction in ALT
≥80 mSec reduction in cT1
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 Studies
Each of the company’s clinical studies to date are or have been conducted as non-investigational new drug application (IND) clinical studies under U.S. Food and Drug Administration regulations and guidance supporting research with food. These studies evaluate product candidates for safety, tolerability and effects on the normal structures and functions in humans, including in individuals with disease. They are not designed or intended to evaluate a product candidate’s ability to diagnose, cure, mitigate, treat or prevent a disease. If Axcella decides to further develop a product candidate as a potential therapeutic, as is the case with AXA1665 and AXA1125, any subsequent clinical studies will be conducted under an IND.
Internet Posting of Information
Axcella uses its website, 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 company’s website in the "Investors and News" section. Accordingly, investors should monitor this portion of the company’s website, in addition to following its press releases, SEC filings and public conference calls and webcasts.
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 and the company’s characterization of the results from its clinical studies and future clinical trials, including for AXA1125, the company’s anticipated program milestones, including the design, status and timing of the planned Phase 2b clinical trial of AXA1125 in adult NASH, the subject and timing of the company’s planned interactions with the FDA, including the timing of IND submissions, and the potential of the company’s product candidates to impact health and/or disease, including AXA1125’s potential in NASH. 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 submission 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 SEC filings, including Axcella’s Annual Report on Form 10-K, 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 company’s 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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