India Pharma Outlook Team | Wednesday, 24 January 2024
Early-stage biotechnology company Virios Therapeutics, Inc. announced plans to use IMC-2 (a combination of valacyclovir and celecoxib) to treat fatigue, orthostatic intolerance and other symptoms of LC (also known as post-acute). Consequences of SARS-CoV-2 infection (PASC).
The company is targeting the initiation of a phase 2 programme in the second half of 2024, with data expected in 2025, as per pharmabiz.
“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,” said Greg Duncan, chairman and CEO of Virios Therapeutics. “There are currently no FDA-approved LC treatments, thus IMC-2 has 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 program, 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 has provided the Bateman Horne Center with an unrestricted investigational grant to fund their ongoing placebo-controlled 12-week study of the valacyclovir/celecoxib combination in up to 60 LC patients, with data expected by mid-year 2024. In addition, we have received input from the FDA on development requirements and key endpoints associated with advancing IMC-2 into phase 2 development as a treatment for LC symptoms. We are now taking the organizational steps necessary to prepare for the initiation of a phase 2 clinical program in the second half of this year. We further expect to provide an update on potential partnership developments later this quarter,” Duncan concluded.
Virios Therapeutics is an early stage biotechnology company focused on the development of new antiviral drugs for the treatment of diseases associated with an abnormal immune response caused by a virus, such as fibromyalgia (FM) and Long-Covid (LC).
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