Virios Therapeutics Announces Submission of Final Toxicology Results to Support Proposed Phase 3 Program for Novel Therapy to Treat Fibromyalgia
May 15 2023 - 7:05AM
Virios Therapeutics, Inc. (Nasdaq: VIRI) (the “Company”), a
development-stage biotechnology company focused on advancing novel
antiviral therapies to treat debilitating chronic diseases,
including fibromyalgia (“FM”), today announced that it has
submitted final toxicology reports as per Food & Drug
Administration (“FDA”) request as part of their overall review of
the Company’s Phase 3 proposal.
Key Highlights
- Proposed Phase
3 program for lead development candidate IMC-1 to the FDA as
treatment for FM consisting of four primary components: two
adequate and well-controlled clinical studies, one of which would
be a full factorial design with each of the individual components
of IMC-1 (famciclovir and celecoxib) as separate comparator arms, a
long-term safety trial, and a pharmacokinetic/food effect
study.
- Based on data
from its recently completed FORTRESS Phase 2b trial, the Company
proposed a Phase 3 development program targeting community-based FM
patients, who have not participated in prior FM trials.
“We are pleased to report that we have submitted
the final toxicology program results in support of our proposal to
advance IMC-1 to Phase 3 development,” said Greg Duncan, Chairman
and CEO of Virios Therapeutics. “We will report material FDA
feedback on our Phase 3 proposal promptly, as we receive it.”
About Virios Therapeutics
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, a combination of 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 the 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.
For more information, please visit
www.virios.com.
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Forward-Looking Statements
Statements in this press release contain
“forward-looking statements,” within the meaning of the U.S.
Private Securities Litigation Reform Act of 1995, 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,” “suggest,” “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, timing and results of
current and future clinical studies relating to Virios
Therapeutics’ product candidates. 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,
2022, filed with the Securities and Exchange Commission.
Forward-looking statements contained in this announcement are made
as of this date, and Virios Therapeutics, Inc. undertakes no duty
to update such information except as required under applicable
law.
Contact:IR@Virios.com
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