Axcella Therapeutics has commenced a Phase IIa clinical trial to assess its therapy, AXA1125, to potentially treat long Covid-19 patients.
A complex condition, long Covid-19 is also called post-Covid-19 and post-acute sequelae of Covid-19 (PASC).
On 22 October, the UK Medicines and Healthcare products Regulatory Agency (MHRA) had accepted the company’s clinical trial authorisation (CTA) submission for Phase IIa.
Anticipated to commence at the Oxford Centre for Clinical Magnetic Resonance Research by this year-end, the randomised, placebo-controlled double-blind trial will assess the efficacy and safety of AXA1125 in subjects with exertional fatigue linked to long Covid-19.
It will enrol nearly 40 subjects, who will be categorised to receive either 67.8g AXA1125 daily or a matching placebo for 28 days.
The trial will be led by the University of Oxford’s Radcliffe Department of Medicine scientists and have a safety follow-up duration of one week.
Axcella anticipates top-line results from the trial during the middle of next year.
The improvement of mitochondrial function in the skeletal muscle from baseline to day 28 as assessed by variations in phosphocreatine (PCr) recovery time will be the trial’s primary goal.
Lactate levels, fatigue scores, a walk test for six minutes, and safety and tolerability will be the key secondary goals.
Axcella R&D president Dr Alison Schecter said: “While Long Covid’s enormous patient and socioeconomic burden has become readily apparent, its underlying pathophysiology is now emerging.
“In two prior successful clinical studies and in preclinical models, AXA1125 has demonstrated an ability to restore mitochondrial function and improve energetic efficiency via increased fatty acid oxidation, restored cellular homeostasis, and reduced inflammation.”
The company is analysing AXA1125 in non-alcoholic steatohepatitis patients in the Phase IIb EMMPACT trial.