Axcella Therapeutics is making strides in the fight against Long COVID fatigue with its AXA1125 therapeutic. On Monday, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) gave the green light to a single trial of the innovative treatment, marking a major step forward in the battle against the debilitating condition.
The Massachusetts-based biotech firm has taken a major step towards advancing its groundbreaking new drug, AXA1125, as they have filed an Investigational New Drug application with the FDA. This application seeks to initiate a Phase IIb/III trial, which would bring the potential treatment one step closer to helping millions of people across the globe.
On Tuesday morning, Bill Hinshaw, President and CEO of Axcella, announced that the company is launching a comprehensive global study to gain regulatory approval for their product. This integrated trial is expected to provide valuable insights for the company’s progress.
The MHRA and Axcella were able to work together in accordance with the regulatory guidance to reach an agreement on the critical trial components, such as the primary endpoint and design. By collaborating in this way, they were able to ensure the trial would be conducted in a manner that complied with the applicable regulations.
In August 2022, Axcella reported promising Phase IIa results for its candidate, AXA1125. Patients treated with the drug saw remarkable improvements in total, mental and physical fatigue scores compared to the placebo group. In response to the promising results, Axcella has taken steps to engage both the FDA and MHRA to further progress the candidate.
Axcella’s candidate proved to be highly effective, significantly increasing the distance traveled during the 6-minute walk test – an objective measure of physical ability. This groundbreaking treatment has been instrumental in improving mobility and providing renewed hope to individuals suffering from the condition.
AXA1125 is a breakthrough endogenous metabolic modulator that works by precisely blending together several essential amino acids and their derivatives in specific ratios in order to modulate metabolic pathways associated with the disease. This innovative approach promises to revolutionize the way we treat and prevent certain conditions.
A Lingering Issue
COVID-19 is not just a short-term nuisance, as many of its victims are finding out; it can come with long-term health implications. Known as “Long COVID”, this condition is characterized by a wide range of symptoms, including extreme fatigue, fever, difficulty breathing, chest pain, headaches, and sleeping problems. Those who experience Long COVID may find their lives profoundly changed, as the condition can have a lasting impact on their health and wellbeing.
It is estimated that Long COVID has impacted the lives of around 100 million people globally, with fatigue being the most common symptom. Despite its recent emergence, the full impact of this condition is still unknown.
In the U.S., the devastating impact of Long COVID has been felt by over 1 million individuals who have been forced out of work. This has resulted in a staggering loss of $1 trillion in earnings and a further $529 billion in medical expenditures. It is clear that Long COVID has had a devastating effect on the lives of many.
As the world continues to grapple with the impact of Long COVID, a number of biotech companies are working hard to develop therapies that can help those affected. Companies like Axcella are leading the way in researching potential treatments, but they are not alone. Other biotechs are exploring innovative solutions, from cellular therapies to gene therapies, in order to reduce the long-term effects of Long COVID and improve the quality of life for those suffering from it.
Tevogen’s precision T cell candidate, TVGN-489, has shown promise in a proof-of-concept trial, with none of the coronavirus patients treated developing Long COVID. This encouraging result has spurred the company to investigate further, in an effort to harness the therapeutic potential of their candidate.
In October 2022, Precision Genomics announced their revolutionary mRNA technology, designed to help diagnose Long COVID and develop effective treatment protocols. With a proprietary 48-gene microarray and an AI program to identify genetic patterns associated with inflammation, Precision Genomics joined Axcella and Tevogen in providing cutting-edge solutions to tackle the global health crisis.