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Submitted URL:
http://www.virios.com/
Effective URL:
https://www.virios.com/
Submission: On December 31 via api (December 31st 2022, 9:10:52 am UTC) from US — Scanned from DE

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Text Content

* ABOUT VIRIOS

* Leadership
* Board of Directors
* Scientific Advisors
* Corporate Presentation

* TARGET DISEASES

* Fibromyalgia
* Long Covid
* Blog

* PIPELINE

* Pipeline
* Presentations and Publications

* INVESTORS

* NEWS

* CONTACT

* More

Use tab to navigate through the menu items.

A NEW TREATMENT PARADIGM
TARGETING VIRAL MEDIATED CHRONIC DISEASES

ABOUT VIRIOS

Virios Therapeutics (Nasdaq: VIRI) is a development-stage biotechnology company
focused on advancing novel antiviral therapies to treat debilitating chronic
diseases, such as fibromyalgia (“FM”). Immune responses related to the
activation of tissue resident herpes have been postulated as a potential root
cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel
disease, chronic fatigue syndrome and other functional somatic syndromes, all of
which are characterized by waxing and waning symptoms with no obvious etiology.
Our lead development candidate (“IMC-1”) is a novel, proprietary, fixed dose
combination of famciclovir and celecoxib designed to synergistically suppress
herpes virus replication, with the end goal of reducing virally promoted disease
symptoms. IMC-1 has been granted fast track designation by the FDA.

The Company is pursuing a second development candidate, IMC-2 (valacyclovir and
celecoxib), as a potential treatment for managing the fatigue, sleep, attention,
pain, autonomic function and anxiety associated with Long-COVID, otherwise known
as Post-Acute Sequelae of COVID-19 (PASC). The Company has provided Bateman
Horne Center (“BHC”) with an unrestricted investigational grant to conduct this
study. BHC is a non-profit, interdisciplinary Center of Excellence advancing the
diagnosis and treatment of chronic fatigue disorders, FM, post-viral syndromes,
and related comorbidities.

About IMC-1: Evidence of IMC-1’s efficacy on a broad spectrum of FM outcome
measures was previously demonstrated in a Phase 2a clinical trial. In this
trial, IMC-1 delivered statistically significant reduction in FM related pain,
fatigue, anxiety and depressive symptoms and improved overall patient health and
functioning. IMC-1 was better tolerated placebo, as evidenced by a lower
drop-out rate due to adverse events on IMC-1 as compared to placebo.

Virios’ novel FM development candidate, IMC-1, demonstrated exemplary safety and
tolerability in the FORTRESS study (a multi-center, randomized, double-blind,
placebo-controlled Phase 2b trial of over 400 FM patients), but did not achieve
statistical significance on the pre-specified primary efficacy endpoint of
change from baseline in daily self-reported average pain severity scores
compared to placebo. However, analysis of the top-line data revealed a
bifurcation of response based on the timing of patient enrollment in the
FORTRESS study that the Company believes is unlikely related to chance. Based on
these results, the Company performed a deeper analysis of the FORTRESS data to
determine factors driving these results to determine whether, and if so, how, to
continue the development of IMC-1.

Post-hoc analysis of the FORTRESS (Fibromyalgia Outcome Research Trial
Evaluating Synergistic Suppression of Herpes Simplex Virus-1) study results
indicated that FM patients who were generally more naïve to prior clinical
studies and prior FM drug treatment (“new” patients), demonstrated clinically
and statistically significant reductions in pain, fatigue, FM symptoms and both
anxiety and depression symptoms. In contrast, FM patients who were prior FM
trial participants and/or study site database patients (“experienced” patients)
did not exhibit a statistically significant treatment benefit in this study.

The Company believes targeting new FM patients for IMC-1 development is the
optimal approach and plans to meet with the U.S. Food & Drug Administration
(“FDA”) with the goal to progress IMC-1 into Phase 3 development.

MEET OUR LEADERSHIP

BOARD OF DIRECTORS

SCIENTIFIC ADVISORS

CORPORATE PRESENTATION

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.

IASP '21 FM P2a Safety Review

IMC-1 P2a FM Study Publication

EULAR '21 FM P2a Results

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.

Synergy

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.

Opportunity

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.

1. Fibromyalgia

2. Irritable Bowel Syndrome

3. Chronic Pelvic Pain

4. Chronic Neck and Back Pain

5. Temporomandibular Joint Dysfunction (TMJ)

6. Long COVID

CONTACT

FOR QUESTIONS REGARDING INVESTOR RELATIONS, PLEASE CONTACT KIRIN SMITH AT:
KSMITH@PCGADVISORY.COM

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HEAD OFFICE

44 Milton Avenue

Alpharetta, GA 30009

info@virios.com

Tel: (866) 620-8655

www.virios.com Open in urlscan Pro 34.149.87.45 Public Scan

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www.virios.com Open in urlscan Pro
34.149.87.45 Public Scan

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