Friday, December 16, 2022
Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators (EMMs). The company’s product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to restore cellular homeostasis in multiple key biological pathways and improve cellular energetic efficiency. Axcella’s pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID and non-alcoholic steatohepatitis (NASH), and the reduction in risk of overt hepatic encephalopathy (OHE) recurrence. The company’s unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. For more information, please visit www.axcellatx.com.
Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.
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Axcella Restructures and Reprioritizes Operations. Axcella has announced a corporate restructuring with changes to its development plans for AXA1125. The Phase 2b trial in NASH has been discontinued while the Long COVID Fatigue indication will move forward. Staff has been reduced by 85%. These actions should allow the operations to continue as strategic alternatives are evaluated.
Focus On Long COVID Fatigue. In August 2022, Axcella announced Phase 2a trial data for AXA1125 in Long COVID Fatigue patients, with data showing promising improvements in physical and mental fatigue. The company plans to continue discussions with the FDA and European regulators to design the next trial and requirements for an application for approval.
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