Virios is a clinical-stage biotech company developing a novel therapy, IMC-1, for the treatment of fibromyalgia (FM).
“In our view, FM is a poorly understood chronic pain condition that is under-diagnosed and insufficiently treated,” writes analyst Sean Lee. Because there is no consensus on the etiology of FM, he said current treatments focus on alleviating specific symptoms, and no treatment can bring relief to a majority of FM patients.
Mr. Lee said scientists at Virios believe that a key underlying cause of FM is the activation of dormant HSV-1 virus due to external stimuli, and have developed IMC-1, a proprietary combination of two approved drugs, famciclovir and an anti-viral, celecoxib, to inhibit the virus.
So far, he said IMC-1 has shown efficacy in a 142-patient randomized Phase 2 study. After 16 weeks of treatment, FM patients experienced improvements in pain, fatigue, sleep quality, and cognitive function.
Besides FM, Virios plans to initiate a Phase 1 study for the treatment of irritable bowel syndrome in mid-2022. The company also plans to initiate a Phase 1 study of IMC-1 in chronic fatigue syndrome in the future.
The company also has several upcoming milestones, with key topline results from the Phase 2b FM study expected in the third quarter of 2022. “If these studies are successful, we believe that IMC-1 could become the therapy of choice for these indications, and Virios could become a major player in these therapeutic areas,” Mr. Lee said.