Axcella Health Inc developed a drug for tackling long COVID and conducted one of the first trials to improve the condition of such patients. Although the drug, AXA1125, failed on the small study’s main goal of restoring the normal function of mitochondria, it gave respite to some patients with lingering physical and mental fatigue.
On Tuesday, the data of the 41-patient pilot study was released and it revealed that 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, as quoted by Reuters.
Meanwhile, other patients 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 as quoted by Reuters.
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 the normal function of mitochondria, the minuscule power plants that help cells perform properly.
In the trial, conducted by the University of Oxford, people received either the Axcella drug or a placebo over a period of 28 days. According to reports, all were more than 12 weeks post-COVID infection and had an abnormal phosphocreatine recovery time, a measure of mitochondrial function.
For the study’s primary goal, there was no statistically significant difference between the groups on phosphocreatine recovery time. The trial also looked at blood tests measuring lactate, a sign of muscle health, as well as patient-reported measures of mental and physical fatigue.
There are currently no approved treatments for chronic fatigue in patients with long COVID, a condition estimated to affect more than one hundred million people worldwide. Axcella Chief Executive Bill Hinshaw said the company is designing new trials and plans to meet with U.S. and UK regulators with hopes of seeking an accelerated approval pathway for this enormous unmet need.
(With inputs from Reuters)