Axcella Granted Patent for Long COVID Fatigue Treatment

Axcella Therapeutics (Nasdaq: AXLA), a clinical-stage biotechnology company focused on pioneering a new approach to address the biology of complex diseases using compositions of endogenous metabolic modulators (EMMs), today announced that the U.S. Patent and Trademark Office (USPTO) has granted U.S. Patent No. 11,737,999 with claims covering methods of use of Candidate AXA1125, for treating a subject having post-acute sequelae of COVID-19 (PASC), a/k/a Long COVID, particularly fatigue. The patent was issued on August 29, 2023, with anticipated expiration in 2042.

“Today’s issuance expands our global patent portfolio and Axcella’s protection of its lead candidate, AXA1125,” said Paul F. Fehlner, J.D., Ph.D., Senior Vice President, Chief Legal Officer of Axcella. “These patents and our entire portfolio are fully owned by Axcella.”

AXA1125 is a novel composition of EMMs designed to simultaneously support metabolic, inflammatory and fibrotic pathways associated with fatigue. Axcella was previously granted patents related to AXA1125 with claims covering methods of use and compositions. In particular, Patents Nos. 10,201,513, 10,471,034, 11,129,804, and 11,602,511 cover the AXA1125 compositions, including pharmaceuticals and nutritional supplements. These previously granted patents have an anticipated expiration date in 2037.

“In addition to further strengthening Axcella’s global intellectual property position regarding its proprietary composition of amino acids in AXA1125, today’s patent issuance further validates AXA1125’s formulation and its tie to treating PASC or Long COVID, explicitly symptoms of fatigue,” said Bill Hinshaw, President and Chief Executive Officer of Axcella. “We are pleased to have this additional designation as we pursue options to bring our investigational product forward for the benefit of the millions of people who continue to suffer from Long COVID Fatigue. The understanding of the disease continues to advance and show the importance of mitochondrial function and how a mitochondrial activator like AXA1125 has the potential to impact the issues these patients face.”

About Endogenous Metabolic Modulators

Endogenous metabolic modulators, or EMMs, are a broad family of molecules, including amino acids, which fundamentally impact and regulate human metabolism. Our AXA candidates are anchored by EMMs that 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 support and modulate multiple metabolic pathways implicated both in complex diseases and overall health.