US-based biotechnology company Virios Therapeutics has unveiled its plans to advance the development of its IMC-2 combination therapy for the treatment of long-Covid (LC).
IMC-2 is a combination of valacyclovir and celecoxib. It is intended to treat fatigue, orthostatic intolerance and other symptoms associated with LC, also called post-acute sequelae of SARS-CoV-2 infection (PASC).
Virios is planning to start the Phase 2 programme in the second half of this year, with data expected by 2025.
The biotechnology firm has offered an unrestricted investigational grant to the Bateman Horne Center to support its ongoing 12-week placebo-controlled trial of IMC-2.
The study is being conducted on 60 long Covid-19 patients. The result from this study is expected later this year.
Virios has also received input from the US Food and Drug Administration (FDA) on development requirements and key endpoints associated with Phase 2 development of IMC-2.
Virios Therapeutics chairman and CEO 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 the potential to be one of the first therapies for addressing LC symptoms.
“With FDA agreement that fatigue reduction can serve as the primary endpoint in this programme, success on the LC indication may allow extension to other fatigue-related illnesses such as Chronic Fatigue Syndrome, thereby expanding our potential market opportunity.”
Virios is focused on the development of antiviral therapies to treat diseases related to a viral-triggered abnormal immune response like fibromyalgia (FM) and LC.
The company’s lead development assets are proprietary, fixed-dose combinations of an antiviral compound and celecoxib.
Its IMC-1 candidate has secured US FDA fast-track designation.
