ME Association Comment
“Myself and Dr Karl Morten, who receives funding from the MEA Ramsay Research Fund to carry out research into mitochondrial dysfunction in ME/CFS, have been following this Oxford-based clinical trial very closely.
“As the trial is taking place in Oxford, where Karl is also based, we have been in contact with Dr Betty Raman (see below) to discuss the possibility of extending the trial to people with ME/CFS – where debilitating physical and mental fatigue is a key concern and the role of mitochondrial dysfunction and defects in cellular energy production are well documented.
“The results from this small clinical trial obviously have to be regarded with caution at this stage. Only 14% of patients were shown to have fatigue return to normal levels and it failed to demonstrate restoration of mitochondrial function. Further work involving larger numbers of people with Long Covid needs to be carried out in order to establish whether this intervention can really improve functional ability.
“If this can be determined by additional research, the MEA Ramsay Research Fund would welcome a grant application to repeat the trial in people who have ME/CFS.”
Dr Charles Shepherd, Hon. Medical Adviser, The ME Association
By Julie Steenhuysen, Reuters News Agency, 02 August 2022
One of the first trials aimed at tackling long COVID helped some patients recover from lingering physical and mental fatigue, although the drug developed by Axcella Health Inc. failed on the small study's main goal of restoring the normal function of mitochondria – the energy factories of cells.
In the 41-patient pilot study released on Tuesday, for three of 21 patients who received the drug, AXA1125, their physical fatigue scores returned to normal levels after 28 days of treatment, Axcella Chief Medical Officer Margaret Koziel said in a phone interview.
Others who received the drug also reported physical and mental improvements that were deemed to be statistically significant as shown on a scale developed to measure chronic fatigue, according to the preliminary results, and the drug was shown to be safe and well tolerated.
“This trial is suggesting that a drug that's very safe to take and has minimal side effects is causing substantial improvement in people's physical and cognitive experience of fatigue,” said Dr. Jason Maley, a consultant for Axcella who runs a long COVID clinic at Beth Israel Deaconess Medical Center in Boston.
The drug, originally developed for fatty liver disease, aims to treat the crushing chronic fatigue reported by more than half of long COVID sufferers by restoring normal function of mitochondria, the minuscule power plants that help cells perform properly.
People in the trial conducted at the University of Oxford received either the Axcella drug or a placebo over a period of 28 days. All were more than 12 weeks post COVID infection and had an abnormal phosphocreatine recovery time, a measure of mitochondrial function.
“The statistically significant improvement in reported mental and physical fatigue among study participants receiving AXA1125 is a very encouraging finding for Long COVID patients, who often experience extreme and constant fatigue throughout their day,” said study leader, Dr. Betty Raman, Associate Professor of Cardiovascular Medicine at the Radcliffe Department of Medicine, University of Oxford.
Press Release: Axcella Announces Highly Promising Results from Phase 2a Placebo Controlled Clinical Trial for Long COVID | 02 August 2022
“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,” said lead researcher Dr. Betty Raman, British Heart Foundation Oxford Centre for Research Excellence Transition Clinical Intermediate Fellow.
“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.”
RDM researchers test potential treatment for fatigue in long COVID patients | October 2021