Virios Therapeutics Announces Oral Presentation of Clinical Data at Digestive Disease Week® (DDW)
May 24 2021 - 7:05AM
Business Wire
Virios Therapeutics, Inc. (Nasdaq: VIRI), a
clinical-stage biotechnology company focused on advancing novel
antiviral therapies to treat diseases associated with virally
triggered or maintained immune responses, announced today that
clinical data was highlighted in an oral presentation at Digestive
Disease Week® (“DDW”) 2021, the premier global meeting for
physicians, researchers and industry in the fields of
gastroenterology, hepatology, endoscopy and gastrointestinal
surgery, which was held virtually May 21 – 23, 2021.
“The data presented by Dr. Duffy comprised a tissue biopsy study
jointly conducted between the University of Alabama and Virios
Therapeutics,” commented R. Michael Gendreau, M.D., Ph.D., Chief
Medical Officer of Virios Therapeutics. “The study examined gastric
mucosa biopsies from three cohorts: patients with functional
gastrointestinal disorders (“FGID”), patients with both FGID and
fibromyalgia (FM), and control patients. Biopsy specimens were
analyzed for the presence of active herpesvirus infections. As is
discussed in the presentation, there was a marked increase in the
presence of actively replicating herpes simplex virus type 1
(HSV-1) in gastric mucosal tissue from FGID and FGID + FM patient
groups as compared to control patients.”
“This finding highlights the potential role of activated HSV-1
as a potential root cause of chronic gastrointestinal disorders.
Furthermore, this presentation provides further visibility to the
medical community on the potential utility of combination antiviral
drug therapies, such as IMC-1, for patients with chronic illnesses
such as fibromyalgia (“FM”) and irritable bowel syndrome (“IBS”),
which are characterized by waxing and waning manifestation of
disease,” concluded Dr. Gendreau.”
Session: Clinical Science Late-Breaking Abstract
Plenary
Title: Active Herpes Simplex Virus Type 1 Infection of
the Gastric Mucosa is Associated with Functional Gastrointestinal
Disorders: A Pilot Case-Control Study (Abstract # 3581012)
Presenter: Carol Duffy, Ph.D., University of Alabama
Conclusions: Analysis of gastric mucosa biopsies revealed
a significant positive association between actively replicating
gastric HSV-1 and multiple functional gastrointestinal disorders,
with and without concomitant FM. FGIDs including IBS, functional
dysphagia, and functional dyspepsia may be related to active HSV-1
infection. Further investigation into the prevalence and possible
causal nature of this association is warranted.
For more information, please visit www.virios.com.
About IMC-1
IMC-1 is a novel, proprietary, fixed dose combination of
famciclovir and celecoxib. This dual mechanism antiviral therapy is
designed to synergistically suppress Herpes Simplex Virus-1
(“HSV-1”) activation and replication, with the end goal of reducing
viral mediated disease burden. IMC-1 combines two specific
mechanisms of action purposely selected to inhibit HSV-1 activation
and replication, thereby keeping HSV-1 in a latent (dormant) state
or “down-regulating” HSV-1 from a lytic (active) state back to
latency. The famciclovir component of IMC-1 inhibits viral DNA
polymerase necessary for replication. The celecoxib component of
IMC-1 inhibits both cyclooxegenase-2 (“COX-2”) and COX-1 enzymes,
used by HSV-1 to accelerate its own replication. Virios
Therapeutics holds a U.S. “Composition of Matter” Synergistic
Patent (US 10,251,853) for the synergistic combination for total
daily dose of famciclovir and celecoxib.
About Virios Therapeutics
Virios Therapeutics (Nasdaq: VIRI) is a clinical-stage
biotechnology company focused on advancing novel, dual mechanism
antiviral therapies to treat conditions associated with virally
triggered or maintained immune responses, such as fibromyalgia
(“FM”). Immune responses related to the activation of tissue
resident Herpes Simplex Virus-1 (“HSV-1”) have been postulated as a
potential root cause triggering and/or sustaining chronic illnesses
such as FM, irritable bowel disease (“IBS”), 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 HSV-1 replication, with the
end goal of reducing virally promoted disease symptoms.
Evidence of IMC-1’s efficacy on a broad spectrum of FM outcome
measures was previously demonstrated in a Phase 2a clinical trial.
These trial results are suggestive that IMC-1 may represent a new
and novel treatment for fibromyalgia. IMC-1 has been granted fast
track designation by the FDA and is currently being tested in a
multi-center, randomized, double-blind, placebo-controlled Phase 2b
trial (“FORTRESS”) designed to set the stage for registrational
studies. The company is led by an executive team highly experienced
in the successful development and commercialization of novel
therapies. For more information, please visit www.virios.com.
Forward-Looking Statements
Statements in this press release contain “forward-looking
statements” that are subject to substantial risks and
uncertainties. All statements, other than statements of historical
fact, contained in this press release are forward-looking
statements. Forward-looking statements contained in this press
release may be identified by the use of words such as “anticipate,”
“believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,”
“seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,”
“target,” “aim,” “should,” "will” “would,” or the negative of these
words or other similar expressions, although not all
forward-looking statements contain these words. Forward-looking
statements are based on Virios Therapeutics’ current expectations
and are subject to inherent uncertainties, risks and assumptions
that are difficult to predict, including risks related to the
completion and timing of the Phase 2b trial. Further, certain
forward-looking statements are based on assumptions as to future
events that may not prove to be accurate. These and other risks and
uncertainties are described more fully in the section titled “Risk
Factors” in the Annual Report on Form 10-K for the year ended
December 31, 2020 filed with the Securities and Exchange
Commission. Forward-looking statements contained in this
announcement are made as of this date, and Virios Therapeutics,
Inc. (VIRI) undertakes no duty to update such information except as
required under applicable law.
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Dave Gentry 1-800-733-2447 +1-407-491-4498 dave@redchip.com or
ir@virios.com
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