Axcella Presents Data for AXA1125 at The Liver Meeting® 2020

Poster presentations highlight AXA1125’s multifactorial activity; potentially differentiating and enhanced effects in subjects with type 2 diabetes

CAMBRIDGE, MA, USA I November 13, 2020 IAxcella (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:

Threshold Subjects on Placebo Subjects on AXA1125
≥30% reduction in MRI-PDFF 8.3% 38.5%
≥17 U/L reduction in ALT 25.0% 38.5%
≥80 mSec reduction in cT1 16.7% 34.6%
≥2 ng/mL reduction in ProC3 33.3% 50.0%

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:

Threshold T2D Subjects on Placebo T2D Subjects on AXA1125
≥30% reduction in MRI-PDFF 0% 54.5%
≥17 U/L reduction in ALT 33.3% 63.6%
≥80 mSec reduction in cT1 33.3% 45.5%

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.

About Axcella

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.

SOURCE: Axcella

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