Friday, September 30, 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 Announced Positive Interim NASH Results. An interim analysis from the Phase 2b EMMPACT Study of AXA1125 in non-alcoholic steatohepatitis (NASH) showed improvements in measures of liver fibrosis and liver fat. The data presented was from patients who had been treated for 12 and 24 weeks of the 48-week treatment period. The study is continuing as planned, and we believe the interim data raise the probability of success for the trial.
Study Design and Analysis. The EMMPACT study was designed to test two doses of AXA1125 against placebo. Patients receive either placebo, low dose (45.2g/day), or high dose (67.8g/day) twice daily for 48 weeks. It has a target enrollment of 270 patients with biopsy-confirmed Stage 2 or Stage 3 NASH, divided into three arms with 90 patients each. The interim analysis used non-invasive tests to evaluate reduction in liver fibrosis and inflammation.
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