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- Patient screening is underway in the UK to assess the potential of oral product candidates to address long-term COVID fatigue and muscle weakness
- Expected to achieve top data readings by mid-2022
Axcella Therapeutics (NASDAQ:AXLA), a clinical-stage biotechnology company that has pioneered a new method of using a multi-target endogenous metabolic modulator (EMM) composition to treat complex diseases. Researchers from the Radcliffe Department of Medicine at the University of Oxford announced today, Patient screening is currently underway in Phase 2a. AXA1125 (an oral product drug candidate) is being studied as a potential treatment for Long COVID (also known as post-COVID-19 illness and acute sequelae after SARS-COV-2 infection (PASC)) test.
Principal Investigator, Dr. Betty Raman, Intermediate Research Fellow for Clinical Transition at the Oxford Centre of Excellence for the British Heart Foundation, said: “Participating in this trial in patients suffering from chronic Covid fatigue has aroused great interest.” “In view of patients affected by this syndrome The large number of them is experiencing life-changing symptoms, and there are currently no treatment options at all. This is not surprising. We are keen to evaluate the effects of AXA1125 on mitochondrial and muscle function and its potential to improve functional outcomes in urgently needed patients.”
Phase 2a is a randomized, double-blind, placebo-controlled trial that is evaluating the efficacy and safety of AXA1125 in patients with fatigue related to Long COVID. Approximately 40 British patients will be enrolled and randomly assigned to receive 67.8 grams of AXA1125 or matching placebo per day in two divided doses for a period of 28 days and a safety follow-up period of one week.
“A growing body of evidence shows that infection with the COVID-19 virus impairs the ability of mitochondria to act as a’cell power source’, manifested in chronic COVID fatigue and muscle weakness,” said Dr. Alison Schecter, the company’s R&D president Aksela . “Our preclinical and clinical research results to date show that AXA1125 has the potential to improve many aspects of mitochondrial biology, including increasing energy and reducing inflammation. This gives us hope that we can help tens of millions of people with this disease. The patient brings a real change. A state of weakness.”
The primary endpoint of this phase 2a trial is the change in creatine phosphate (PCr) recovery time from baseline to day 28, as measured by 31-phosphorus magnetic resonance spectroscopy (pMRS). In past clinical trials, this highly sensitive and effective measurement of mitochondrial function was associated with the six-minute walk test, which has become the registration endpoint for other fatigue-related conditions (such as primary pulmonary hypertension and exertional angina). The key secondary endpoints in…
The full story can be found on Benzinga.com
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