Axcella announced it is initiating a new clinical program to study AXA1125 in patients with Long Covid. The trial will be conducted at the Oxford Centre for Clinical Magnetic Resonance Research.
Axcella Therapeutics announced it is initiating a new clinical program to study AXA1125 in patients with Long Covid, also called Post COVID-19 Condition and Post-Acute Sequelae of COVID-19 (PASC). The trial will be conducted in the UK.
In general, most people with COVID-19 recover within weeks. But some people experience a wide range of new, returning or ongoing health problems, which has been dubbed Long Covid. According to the U.S. Centers for Disease Control and Prevention (CDC), symptoms can include difficulty breathing or shortness of breath, fatigue, post-exertional malaise, so-called “brain fog” or difficulty thinking or concentrating, cough, chest or stomach pain, headache, heart palpitations, joint or muscle pain and others.
There have been more than 240 million cases of COVID-19 reported globally, and about 25%, or 60 million, have reported long-term effects.
A new study published in JAMA Network Open demonstrated that almost 25% of COVID-19 patients in a Mount Sinai Health System registry described some problems with their memory, although it was more common in hospitalized patients.
“In this study, we found a relatively high frequency of cognitive impairment several months after patients contracted COVID-19,” wrote Jacqueline Becker and her colleagues in the study. “Impairments in executive functioning, processing speed, category fluency, memory encoding, and recall were predominant among hospitalized patients.”
David Putrino, Director of Rehabilitation Innovation at Mount Sinai, said, “Our work and the work of others has shown that this affects people’s abilities to make plans, synthesize information, and do their daily activities of work. They suffer from a lot of memory loss and inability to form new memories, as well as difficulty with speaking. This is a very debilitating condition with serious cognitive conditions.”
The Axcella study is in collaboration with researchers at the Radcliffe Department of Medicine at the University of Oxford. It will begin by the end of 2021 at the Oxford Centre for Clinical Magnetic Resonance Research. Topline data is expected by the middle of 2022.
AXA1125 is a composite of six amino acids and derivatives that targets multiple metabolic pathways. In May, the company initiated the EMMPACT Phase IIb trial of the drug in nonalcoholic steatohepatitis (NASH), a form of fatty liver disease that can lead to liver cirrhosis.
The Long Covid study will be a randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of AXA1125 in patients with exertional fatigue associated with Long Covid. It will enroll about 40 patients who will be randomized 1:1 to receive either 67.8 grams per day of AXA1125 or a matched placebo in two divided doses for 28 days and a one-week safety follow-up period.
The primary endpoint will be to evaluate the improvement of mitochondrial function within the skeletal muscle from baseline to Day 28. This will be measured by changes in phosphocreatine (PCr) recovery time by way of 31-phosphorus magnetic resonance spectroscopy (MRS). Key secondary endpoints will include lactate levels, a 6-minute walk test, fatigue scores, and safety and tolerability. Mitochondrial dysfunction is suspected of contributing to the fatigue associated with Long Covid.
“While Long COVID’s enormous patient and socioeconomic burden has become readily apparent, its underlying pathophysiology is now emerging,” said Alison Schecter, President of R&D at Axcella. “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. This provides us with confidence about its potential to help the growing number of patients who are suffering from COVID’s debilitating effects long after contracting the virus.”
