Virios Therapeutics (Nasdaq: VIRI) is a development-stage biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with a viral triggered abnormal immune response such as fibromyalgia (“FM”) and Long-COVID (“LC”). Overactive immune response related to activation of tissue resident herpesvirus has been postulated to be a potential root cause of chronic illnesses such as FM, irritable bowel syndrome, LC, chronic fatigue syndrome and functional somatic syndrome, all of which are characterized by a waxing and waning manifestation of disease, often triggered by events which compromise the immune system. Our lead development candidates are novel, proprietary, fixed dose combinations of an antiviral compound and celecoxib designed to synergistically suppress herpesvirus replication, with the end goal of reducing virally promoted disease symptoms. IMC-1 (fixed dose combination of famciclovir and celecoxib) has been granted fast track designation by the FDA. The Company plans to engage the FDA in the latter half of 2023 with the goal of filing an investigational new drug application to formally assess IMC-2 (fixed combination of valacyclovir and celecoxib) as a potential treatment for Long-COVID sequelae.
Our Novel Approach to Treating Virally Mediated Fibromyalgia (FM)
Patients with FM have a problem with central pain processing. The exact causality of the heightened pain sensitivity in FM is poorly understood. What is generally agreed is that the central sensitization seen in FM is secondary to a combination of genetic and environmental factors that render the patient susceptible to developing the widespread chronic pain and related symptoms seen in FM. We believe that, when FM patients are exposed to significant life stressors, be they physical or emotional, it results in an abnormal stress which activates herpes virus mediated-immune response. Herpes viruses are unique in that they remain in a dormant state (latency) in neuronal nuclei as nonintegrated, circular DNA associated with nucleosomes, with recurrent reactivations for the life of the host (as seen here). We believe it is likely that nerve resident viral herpetic reactivation is necessary for the waxing and waning nociceptive manifestation of FM. This cyclical process of virus reactivation and lytic infection of herpes viruses is postulated to perpetuate FM symptoms in these patients. IMC-1 is proprietary, fixed dose, orally administered tablet combination of famciclovir and celecoxib designed to synergistically suppress herpes activation and replication, with the end goal of reducing viral mediated disease burden.
Unmet Medical Need
Despite a very high disease burden, just
over one in two (56%) patients currently diagnosed with FM are actively being treated with prescription medication. Furthermore, the three medicines approved to treat FM can give rise to a side-effect burden which limits their use. Even presently treated patients often have to manage the sub-optimal outcomes associated with using unapproved and/or potentially harmful medications to manage their FM disease.
For example, almost 40% of FM patients
are treated with opioids, despite well-established addictive properties, as well
as published references highlighting worse treatment outcomes for opioid-treated patients.
Our novel therapeutic is directed at interrupting the ongoing immune response by suppressing herpes viruses, which suppresses the abnormal stress response, thereby alleviating the central pain processing abnormality and other FM symptoms. Studies have shown that neither antivirals nor COX-2/nonsteroidal anti-inflammatory drugs (“NSAIDS”) taken alone result in a meaningful clinical benefit. However, when administered in combination, a synergistic response has been observed in preliminary clinical studies. The IMC-1 Phase 2a study generated proof-of-concept evidence of clinically significant pain reduction and
symptom alleviation through the coaction of the proprietary, fixed-dose combination of celecoxib and famciclovir.
Failed antiviral monotherapy - Kendall et al.
Failed NSAID monotherapy - Derry et al.
IMC-1’s antiviral mechanism represents an approach that can be directed at FM, IBS and CFS patents, as well as Somatic Symptom Disorder (SSD). These additional chronic conditions represent
a substantially larger market opportunity. The below listed SSD conditions are all chronic pain-related conditions that may be responsive to treatment with IMC-1.
2. Irritable Bowel Syndrome
3. Chronic Pelvic Pain
4. Chronic Neck and Back Pain
5. Temporomandibular Joint Dysfunction (TMJ)
6. Long COVID