The University of Oxford is leading a new a phase 2a clinical trial to investigate whether a drug could treat the fatigue and muscle weakness experienced by many patients who have recovered from COVID.
The drug, AXA1125, is developed by the US-based biotechnology company Axcella Therapeutics.
More than 240 million cases of COVID-19 have been reported worldwide to date, and a US study estimated that a nearly a quarter of US COVID-19 patients suffer long-term effects from the virus. This constellation of long-term symptoms is collectively called long COVID.
Fatigue and muscle weakness is the commonly reported symptom in long COVID patients, and a dysfunction in the mitochondria (the cell’s energy factories) is one potential explanation for these symptoms.
Dr Betty Raman, British Heart Foundation Oxford Centre for Research Excellence Transition Clinical Intermediate Fellow and lead researcher, said: 'Long COVID is having a truly devastating impact on countless people around the world, leaving many with a sense of hopelessness. It is widely recognized that mitochondrial dysfunction may contribute to the profound fatigue associated with this condition.
'With no approved Long COVID therapies, the need for continued innovation is urgent. I am pleased to be leading an investigation of AXA1125 to understand its potential to restore cellular energetics and address patients’ needs.'
The trial will be conducted at Oxford Centre for Clinical Magnetic Resonance Research, based at the John Radcliffe Hospital
Dr Alison Schecter, President of R&D at Axcella, said: 'While Long COVID’s enormous patient and socioeconomic burden has become apparent, its underlying pathophysiology is now emerging,” said . “In two prior successful clinical studies and in preclinical models, AXA1125 has demonstrated an ability to reverse mitochondrial dysfunction and improve energetic efficiency via increased fatty acid oxidation, restored cellular homeostasis, and reduced inflammation. This provides us with confidence about its potential to help the growing number of patients who are suffering from COVID’s debilitating effects long after contracting the virus.”
The Phase 2a trial will be a randomized, double-blind, placebo-controlled investigation to evaluate the efficacy and safety of AXA1125 in patients with exertional fatigue related to Long COVID. Approximately 40 patients will be enrolled and randomized evenly to receive either AXA1125 or a matched placebo.
The research team will be using magnetic resonance spectroscopy to assess any improvements in mitochondrial function within the skeletal muscle in long COVID patients.
Dr Raman also leads the C-MORE study, which tracks COVID-19 patients discharged from hospitals to uncover the long-term effects of the disease, including persistent symptoms, as well as changes in lung and heart function.