Oxford University is currently leading the second phase of a clinical trial for a new drug, AXA1125, to test its efficacy in treating muscle weakness and fatigue caused by long COVID.
Since the beginning of the pandemic, over 240 million cases of Coronavirus have been recorded across the world. According to a US study, nearly 25% of these cases have resulted in a myriad of long-term symptoms, collectively known as long COVID.
Although most people recover fully after 12 weeks, symptoms can persist for much longer. Long COVID can occur even when the initial coronavirus symptoms are mild. Common long COVID symptoms include extreme tiredness, shortness of breath, “brain fog” and muscle weakness. Research suggests that these symptoms could be caused by dysfunctional mitochondria.
British Heart Foundation Oxford Centre for Research Excellence Transition Clinical Intermediate Fellow and lead researcher, Dr Betty Raman, said: “Long COVID is having a truly devastating impact on countless people around the world, leaving many with a sense of hopelessness.
“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.”
Approximately 40 patients will partake in the randomised, double-blind clinical trial, with each receiving either 67.8g of the drug AXA1125 or a matching placebo for 28 days.
The trial will be led by Oxford University’s Radcliffe Department of Medicine, and will be conducted at Oxford Centre for Clinical Magnetic Resonance Research, based at the John Radcliffe hospital.
The drug, AXA1125, has been developed by Axcella Therapeutics, a clinical-stage biotechnology company based in the US. It is also currently being trialled for patients with non-alcoholic steatohepatitis (NASH) in the EMMPACT Phase 2b global clinical trial.
The company’s clinical trial authorisation (CTA) was accepted by the UK Medicines and Healthcare products Regulatory Agency (MHRA) on 22nd October.
Dr Alison Scheter, 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.
“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 main goal of the trial will be to assess the improvement of mitochondrial function in the skeletal muscles. This research will be conducted using magnetic resonance spectroscopy.
Key secondary goals include measuring fatigue scores and lactate levels, as well as a six minute walk test throughout the trial. Researchers will also be measuring the safety and tolerability of the drug.
The clinical trial is scheduled to begin at the end of this year, with top-line data expected by mid-2022.
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