Axcella Therapeutics presents results from Phase 2a clinical trial of AXA1125 for treatment of Long COVID Fatigue

Axcella Therapeutics – a clinical-stage biotechnology company pioneering novel approaches to treating complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions – gave two oral presentations of results from the Phase 2a clinical trial of AXA1125 in the treatment of Long COVID Fatigue.

Lucy Finnigan, Ph.D., M.Res., B.Sc. (Hons.), AFHEA, Oxford Centre for Clinical Magnetic Resonance Research (OCMR), Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, presented efficacy results from the Axcella-sponsored Phase 2a clinical trial. This was a randomized, double-blind, placebo-controlled investigation to evaluate the efficacy and safety of AXA1125 in patients with fatigue related to Long COVID. The study found that subjects who received AXA1125 (n=21) experienced clinically and statistically significant improvement in mental (p=0.0097) and physical (p=0.0097) fatigue scores compared to placebo subjects (n=20). Lancet eClinical Medicine published the trial results on April 14, 2023.

Dr. Finnigan also presented biomarker findings from the Phase 2a trial as part of a session entitled “Novel strategies for anti-COVID treatment: still a challenge.” In conjunction with the reduction in fatigue in patients who received AXA1125, fatigue responders showed significantly greater (p=0.0024) improvement in phosphocreatine recovery time, a marker of mitochondrial function, and a trend towards reductions in plasma FGF-21 (p=0.083) and serum lactate (p=0.073) at day 28 compared with placebo-treated patients.