Chronic fatigue is one of the main symptoms of long Covid. Credit: Meeko Media via Shutterstock.

Virios Therapeutics has announced the advancement of the combination therapy IMC-2 for the treatment of long Covid. 

IMC-2, which is a combination of valacyclovir and celecoxib, aims to target symptoms of long-Covid including fatigue, muscle aches, and orthostatic intolerance (the ability to stand up). The candidate is thought to provide potent suppression of suspected tissue-resident herpes viruses activated by prior infection with the virus. 

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Virios has given an investigational grant to the Bateman Horne Center to support its ongoing 12-week placebo-controlled study of IMC-2 in 60 long Covid-19 patients. Data from this study is expected later this year. 

The company has also received input from the US Food and Drug Administration (FDA) for Phase II development, planning to initiate a Phase II study in H2 2024, with data expected in 2025. 

There is currently no approved cure for the symptoms of long Covid, with research on the mechanisms behind the condition still on-going. According to a report on GlobalData’s Pharma Intelligence Center, anti-inflammatory gout drug colchicine is currently the top drug being tested for long Covid. 

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In July 2023, the company reported positive results from a Phase I study where 22 female SUBJECTS underwent randomisation, receiving twice-daily doses of valacyclovir and celecoxib for 14 weeks. There were statistically significant enhancements in overall health, fatigue, pain, and autonomic dysfunction symptoms. The combined therapy demonstrated good tolerance, with no occurrence of serious adverse events. 

In the announcement accompanying the advancement, chairman and CEO of Virios Greg Duncan said: “We believe the profound unmet medical need associated with LC symptoms provides a unique and timely opportunity for Virios to advance our combination therapy, IMC-2. 

“There are currently no FDA-approved LC treatments, thus IMC-2 has potential to be one of the first therapies for addressing LC symptoms.”