- Axcella Health Inc AXLA is reportedly looking for funding to support its advanced trial of a drug initially found to improve fatigue in long Covid patients.
- An early-stage trial of the drug, dubbed AXA1125, with the University of Oxford, found that participants given the treatment significantly improved fatigue compared with those in the placebo arm, according to the results published Friday in the Lancet eClinical Medicine journal.
- "There is still some way to go in treating all patients with long Covid – our results focus specifically on fatigue, rather than the breathlessness and cardiovascular issues that other long Covid patients have reported," Bloomberg reported citing a statement from Betty Raman, the trial's principal investigator.
- Axcella's Phase 2a trial results demonstrated statistically and clinically relevant improvement in fatigue in patients with Long COVID.
- The study, which did not meet an experimental biomarker primary endpoint, found that subjects who received AXA1125 experienced clinically and statistically significant improvement in mental (p=0.0097) and physical (p=0.0097) fatigue scores compared to placebo subjects.
- Axcella discontinued its Phase 2b trial of AXA1125 in NASH.
- Axcella reported data from Phase 2b EMMPACT study of AXA1125 for nonalcoholic steatohepatitis (NASH). AXA1125 showed a statistically significant improvement in liver stiffness at a higher dose but did not reach statistical significance at a lower dose.
- Half of the 41 patients in the trial received the drug twice daily for four weeks. Participants generally suffered fatigue following Covid for 18 months before the study.
- Axcella has the U.S. and the U.K. regulatory authorization to proceed with advanced trials, and the company plans to enroll about 300 people once funding is secured.
- Price Action: AXLA shares are up 3.33% at $0.39 on the last check Friday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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