Axcella long COVID treatment helps some patients in small trial

Axcella Health

02/08/2022 11:00

By Julie Steenhuysen
    CHICAGO, Aug 2 (Reuters) - 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  AXLA.O  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.
    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.

 (Reporting by Julie Steenhuysen
Editing by Bill Berkrot)
 ((julie.steenhuysen@thomsonreuters.com; 312-408-8131; Reuters
Messaging: Julie.steenhuysen.reuters.com@reuters.net))