Experimental drug AXA1125, to help relieve fatigue in COVID long-haulers, is moving forward in clinical trials. Read on to learn what benefits study participants have experienced, and why researchers are encouraged.

The burden of Long COVID

It’s estimated that 100 million people around the world continue to experience ongoing COVID-19 symptoms, long after they recover from the infection. COVID long-haulers can experience a wide variety of symptoms, with fatigue being the most common.

Long COVID symptoms are generally broken down into four subgroups:

• Kidney and heart,
• Sleep difficulties, anxiety, and lung issues,
• Brain fog, muscle pain, and joint stiffness, and
• Stomach and lungs.

Scientists aren’t sure why some people have lingering symptoms, but it’s thought that inflammation and changes in the immune system could be contributors.

“The drivers of this issue are under investigation,” says Harvard Medical School assistant professor, Jason Maley, M.D. “There are data suggesting persistence of the virus, or remnants of the virus and spike protein may be a trigger for this abnormal immune system activity.”

Drug moves ahead in testing

Boston-based biotech company Axcella Therapeutics recently introduced experimental drug AXA1125 to help relieve chronic fatigue in people living with Long COVID.  

In a phase 2a study, patients who took AXA1125 experienced improvements in physical, mental, and overall fatigue compared to the control group. They were also able to travel a greater distance in a six-minute walk test compared to their counterparts.

Following encouraging data from the phase 2a trial in August 2022, Axcella put in an Investigational New Drug application with the Food and Drug Administration in the U.S., hoping to secure a phase 2b/3 trial. The company has also received regulatory guidance from the U.K.’s Medicines and Healthcare Products Regulatory Agency allowing a single clinical trial for the drug. 

Responding to an urgent need

“Given the devastating health and economic impact that Long COVID is having on millions of patients and their families, there is an urgent need for new treatments developed specifically for this population,” says Oved Amity, co-founder of Long COVID Alliance, a group of advocates, disease experts, scientists, and drug developers working to accelerate post-virus disease research.

“We are encouraged by data from Axcella’s phase two study in Long COVID chronic fatigue patients, the hope that AXA1125 provides to these patients, and by the opportunity to advance the program to a pivotal clinical trial…Patients are waiting.”

*Manalac, T. (2023, January 24). Axcella Clears Regulatory Path for Long COVID Therapeutic (Updated). BioSpace. https://www.biospace.com/article/axcella-clears-regulatory-path-for-long-covid-therapeutic/