Virios Therapeutics Announces Dosing of First Patient in Phase 2b Trial Evaluating IMC-1 in Patients with Fibromyalgia
June 04 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 dosing of
the first patient in its Phase 2b clinical trial, referred to as
FORTRESS (Fibromyalgia Outcome Research Trial Evaluating
Synergistic Suppression of HSV-1), evaluating IMC-1 in patients
with fibromyalgia.
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.
“There is currently widespread dissatisfaction among
fibromyalgia patients, healthcare providers and payers with the
existing FDA approved medications for the management of
fibromyalgia, most notably related to their generally poor
tolerability,” commented R. Michael Gendreau, M.D., Ph.D., Chief
Medical Officer of Virios Therapeutics. “We are excited about the
FORTRESS trial as we are testing optimized doses of IMC-1, and we
will be measuring patients’ fibromyalgia related pain on a daily
basis. Based on industry standard fibromyalgia patient recruitment
rates, we expect to complete the trial and announce top line
results in mid-2022.”
“The dosing of the first patient in this Phase 2b trial marks an
important milestone for Virios, as we develop new, combination
antiviral therapies to improve care standards for patients
suffering from chronic diseases like fibromyalgia and irritable
bowel syndrome,” said Greg Duncan, Chairman and Chief Executive
Officer of Virios Therapeutics. “Virios has a unique potential to
create significant value in meeting the medical need for a new,
safe and effective treatment to help the large market of 10-20
million fibromyalgia patients in the U.S. and more than 200 million
worldwide.”
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 the IMC-1 Phase 2b Clinical Trial
Virios Therapeutics is conducting FORTRESS (Fibromyalgia Outcome
Research Trial Evaluating Synergistic Suppression of HSV-1). This
randomized, double-blind, multi-center, placebo-controlled Phase 2b
trial is expected to enroll approximately 460 patients aged 18-65,
all of whom having been diagnosed using the 2016 American College
of Rheumatology diagnostic criteria for fibromyalgia. The primary
endpoint for this trial will focus on reduction in pain over time,
as measured daily by the Numerical Rating Scale (“NRS”) 24-Hour
Recall scale via an electronic diary that the patient will use at
home for sixteen weeks. In addition to assessing patient’s pain
reduction, secondary endpoints will include change in fatigue,
sleep disturbance, global health status, and patient function.
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210604005022/en/
Dave Gentry 1-800-733-2447 +1-407-491-4498 dave@redchip.com or
ir@virios.com
Virios Therapeutics (NASDAQ:VIRI)
Historical Stock Chart
From Aug 2024 to Sep 2024
Virios Therapeutics (NASDAQ:VIRI)
Historical Stock Chart
From Sep 2023 to Sep 2024