Virios Therapeutics Presents Phase 2a Fibromyalgia Trial Data on Efficacy Analyses of Key Secondary Endpoints at the EULAR Eu...
June 02 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 from its Phase 2a trial of IMC-1 in fibromyalgia
(“FM”) is featured in a poster presentation (poster POS0017) at the
annual EULAR European Congress of Rheumatology, a renowned forum
for interaction between medical doctors, scientists, people with
arthritis/rheumatism, health professionals and representatives of
the pharmaceutical industry worldwide, which is being held
virtually June 2 - 5, 2021. The company’s poster has been selected
to be highlighted in a guided tour entitled “Epidemiology and
treatment of pain in Rheumatic and Musculoskeletal Disorders.”
IMC-1 is a novel, proprietary, fixed dose, antiviral therapy
combining 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.
“Given that FM is associated with a broad spectrum of symptoms
beyond pain, it is important to understand the impact of IMC‑1 on
other FM‑related symptoms,” commented R. Michael Gendreau, M.D.,
Ph.D., Chief Medical Officer of Virios Therapeutics. “In our Phase
2a FM trial, in addition to meeting the primary endpoints of
greater tolerability and significantly greater pain reduction
compared with placebo, patients treated with IMC‑1 reported
significantly greater improvement compared with placebo on the
Revised Fibromyalgia Impact Questionnaire (“FIQ-R”) total score and
on all three FIQ‑R domains. These secondary endpoint results
suggest that IMC‑1 may represent a promising treatment option not
only for alleviating pain, but also for improving other symptoms
associated with FM, such as stiffness, sleep quality, depression,
anxiety and fatigue,” surmised Dr. Gendreau.
Title: IMC‑1, a Fixed Dose Combination of Famciclovir and
Celecoxib, Improves Common Symptoms Associated with Fibromyalgia in
Addition to Pain: Post Hoc Analysis of a Phase 2a Trial
Lead Author: William Pridgen, M.D., Tuscaloosa Surgical
Associates
Conclusions: In this post hoc analysis of a Phase 2a
trial of IMC‑1 in patients with FM, patients treated with IMC‑1
reported significantly greater improvement compared with placebo on
FIQ‑R total scores and on all FIQ‑R domains. Patients receiving
IMC‑1 treatment reported significantly greater improvements versus
placebo on the FIQ‑R symptom items for stiffness, sleep quality,
depression, and anxiety. Improvements in patient global assessments
and in fatigue assessments provide additional evidence for the
beneficial effects of IMC‑1 on FM related symptoms. These results
suggest that IMC‑1 may represent a promising treatment option not
only for alleviating pain, but also for improving other symptoms
associated with FM.
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 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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