Drug helps long COVID patients in small study
reported that their mental and physical state improved significantly after taking the drug in a powdered drink twice a day, compared with 20 patients who received a placebo. Recipients of the drug also walked further in a six-minute test than those who were given the placebo.
“We believe we have already demonstrated in just a month of dosing a profound effect,” said Bill Hinshaw, chief executive of Axcella. His firm developed the experimental drug to combat the muscle weakness and fatigue associated with the fatty liver disease nonalcoholic steatohepatitis, or NASH. The drug is undergoing a separate study for NASH.
Axcella hopes to soon share data from the long COVID study with the US Food and Drug Administration and the UK Medicines and Healthcare Products Regulatory Agency to determine the next step.
Dr. Margaret Koziel, chief medical officer for Axcella and the former director of clinical research at UMass Medical School, said that if regulators approve the drug for long COVID, it’s unclear how long patients would take it. It’s possible the medicine would be used like antidepressants often are, for a few months until patients recover, but it could be prescribed for longer.
“This is a complicated disease,” she said of long COVID. “It’s not a single problem.”
Dr. Jason Maley, head of Beth Israel Deaconess Medical Center’s long COVID clinic, examined the data at Axcella’s request and said the experimental drug is “the first pharmaceutical agent to demonstrate improved outcomes for patients with long COVID” in a clinical trial. The results, said Maley, whom the company paid for his review, suggest that the drug “may play an important role in the longterm treatment” of the disorder.
Two recent publications from the Journal of the American Medical Association found that 10 to 30 percent of people who had COVID-19 reported at least one persistent symptom up to six months after the virus left their bodies.
Axcella, which is publicly traded on the Nasdaq, was founded in 2011 and has about 70 employees. Like many decade-old biotechs, it has yet to get a drug approved.