HSV-1: A Ubiquitous Pathogen, Infecting 67%
of People < Age 50
• IMC-1 Statistically Significant P2a FM data
• FDA Fast Track Review Designation
• Viral infections are possible trigger of CFS/ME
• IMC-1 Statistically Significant Reduction in Fatigue
Chronic Fatigue Syndrome
• Virios GI Biopsy Data Confirm Active HSV-1 in IBS
• ROME IV Criteria Places Increasing Focus on Pain
Irritable Bowel Syndrome
Sources: Priggen WL, et al. J Pain Res. 2017,Schmulson MJ et al. J Neurogastroenterol Motil 2017, Rasa, S., et al. J Transl Med 16, 268 (2018), www.,MA Wozniak. et al, J Pathol 2009, https://www.medscape.com/viewarticle/933619
FM is our top priority disease target as it represents an unmet medical need with a large market opportunity for IMC-1. Physicians are not satisfied with current FM treatments, the etiology and cause of FM remains poorly understood, and currently approved products manage symptoms of FM, without addressing a potential root cause of the disease. We believe the paradigm changing discovery that HSV-1 could play an important role in the pathogenesis of FM was confirmed in our Phase 2a trial, and that wide-scale clinical utility will be further confirmed in our planned Phase 2b trials. If successfully proven, we believe that IMC-1 can be disruptive to the market and can change the way FM is treated. IMC-1’s novel MOA and positive Phase 2a results clearly differentiate it from current and pipeline FM products.
The World Health Organization estimates that more than 3.7 billion people under the age of 50 – or 67% of the population – are infected with herpes simplex virus type 1 (HSV-1). In this context and in parallel to the Phase 2b fibromyalgia program, we at Virios are working with our scientific advisory board to prioritize other diseases that are related to the activation of tissue resident viruses, and are postulated to be a potential root cause of the chronic illness, similar to the way herpes zoster is activated to cause shingles in older patients. Our goal is to identify multiple indications that could benefit by latent HSV-1 remaining dormant, with IBS and functional somatic syndrome being two of our top priorities.
A previously executed GI biopsy study performed in conjunction with research scientists at University of Alabama highlights that HSV-1 infection is active in patients suffering from irritable bowel disease (see details below). We are presently engaged with several leading gastroenterologists to design a phase 2 proof concept study given we believe IBS is a high priority target and clinical studies using IMC-1 or one of our other patented COX-2/Antiviral combinations could be efficiently initiated by utilization of the 505(b)2 regulatory pathway.
Virios currently holds 21 patents that include composition of matter, a unique synergy patent and method of use patents for FM, IBS & CFS patents. as well as Functional Somatic Syndrome (recently renamed the 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. Based on blinded survey data, we believe that many of the SSD conditions will 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. Frequent Headaches