Axcella Announces Patent Issuances Covering AXA1665

Axcella (Nasdaq: AXLA), a clinical-stage biotechnology company focused on leveraging endogenous metabolic modulators (EMMs) to pioneer a new approach for treating complex diseases and improving health, today announced the issuance of two new patents: U.S. Patent 10,682,325 and U.S. Patent 10,660,870. These are the first patents related to Axcella’s family of applications for AXA1665, the company’s product candidate for the reduction in risk of overt hepatic encephalopathy recurrence.

U.S. Patent 10,682,325 covers the composition of AXA1665 as well as other related EMM compositions. U.S. Patent 10,660,870 focuses on methods of use for these EMM compositions in treating a liver disease or disorder involving hyperammonemia and/or muscle wasting.

“Axcella’s goal is to build the world’s leading portfolio of EMM compositions, backed by strong intellectual property,” said Bill Hinshaw, President and Chief Executive Officer of Axcella. “Over the course of the past 18 months, we have grown our number of patent families to 19, covering both our product candidates as well as our platform. We also have more than tripled our number of patent applications to nearly 200 and received our first six patent issuances covering AXA1665, AXA1125, AXA4010 and AXA2678. These accomplishments position us well as we approach potential advanced clinical trials for our lead candidates, AXA1665 and AXA1125.”

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, including AXA1125-003, 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.