Virios Therapeutics Highlights Safety Data from Phase 2a Fibromyalgia Trial at the International Association for the Study of...
June 09 2021 - 07:05AM
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 data
from the company’s Phase 2a clinical trial PRID-201 demonstrated
that IMC-1 was better tolerated than placebo in patients with
fibromyalgia (“FM”). This result is highlighted in a poster
presentation at the International Association for the Study of Pain
(IASP) World Congress, being held virtually June 9 - 11, 2021 and
June 16 - 18, 2021.
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 a clear medical need for new, safe and effective
treatments with the potential to improve care for the estimated 10
- 20 million FM patients in the U.S. and more than 200 million
worldwide,” commented R. Michael Gendreau, M.D., Ph.D., Chief
Medical Officer of Virios Therapeutics. “Our Phase 2a clinical
trial data showed that IMC-1 treated patients had higher overall
completion rates and lower rates of discontinuation due to adverse
events, as compared with placebo-treated patients. This is an
especially encouraging result when viewed in the background of
current patient and provider dissatisfaction with the generally
poor tolerability of existing approved FM treatments,” concluded
Dr. Gendreau.
Title: The Safety of IMC‑1 in Patients with Fibromyalgia:
Phase 2a Study Results
Lead Author: William Pridgen, M.D., Tuscaloosa Surgical
Associates
Conclusions: IMC‑1 exhibited an encouraging safety
profile, as AEs occurred at a lower rate and were less severe in
the IMC‑1 treatment group compared with placebo. The
discontinuation rate due to AEs was nearly 3‑fold higher in
patients receiving placebo compared with patients receiving IMC‑1,
suggesting that treatment with IMC‑1 was unusually well‑tolerated.
In this study, IMC‑1 demonstrated significant reductions in pain,
fatigue, and other important symptoms in patients with FM. These
results suggest that IMC‑1 may offer a promising and well‑tolerated
option to treat patients 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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