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 female patients
diagnosed with Long-COVID illness, otherwise known as Post-Acute
Sequelae of COVID-19 infection (“PASC”), exhibited clinically and
statistically significant improvements in fatigue, pain, and
symptoms of autonomic dysfunction and general well-being related to
Long-COVID when treated open-label with a combination of
valacyclovir and celecoxib (“Val/Cel”) for 14 weeks, as compared to
a control cohort of female Long-COVID patients matched by age,
gender and length of illness and treated with routine care. The
statistically significant improvements in PASC symptoms and general
health status were particularly encouraging given that the mean
duration of Long-COVID illness was two years for both the treated
and control cohort prior to enrollment in this trial.
This open-label, single-center,
investigator-initiated study was conducted at the Bateman Horne
Center (“BHC”) with an unrestricted investigational grant. BHC is a
non-profit, interdisciplinary Center of Excellence advancing the
diagnosis and treatment of chronic fatigue disorders including
myalgic encephalomyelitis/chronic fatigue syndrome (“ME/CFS”), FM,
post-viral syndromes, and related comorbidities.
Based on these data, the Company plans to meet
with the Food and Drug Administration (“FDA”) in the second half of
2023 to discuss opening an investigational new drug application to
formally assess treatment of symptoms associated with PASC using a
fixed dose combination of valacyclovir and celecoxib.
Key Highlights
- Female patients
diagnosed with Long-COVID exhibited clinically and statistically
significant improvements when comparing both within the Val/Cel
cohort and between study cohorts in:
- fatigue as
measured with both the PROMIS fatigue instrument and a numeric
rating scale (“NRS”) for fatigue,
- pain as
measured by a NRS scale for pain,
- and in
autonomic dysfunction symptoms as measured using the Orthostatic
Intolerance Questionnaire.
- Two different
scales for Patient’s Global Impression of Change documented
improvement in overall health when treated with open-label Val/Cel
twice daily for 14 weeks.
- Treatment with
Val/Cel was generally well tolerated, with an observed safety
profile consistent with the known safety profiles of valacyclovir
and celecoxib. There were no serious adverse events observed in
this study and only one treated patient discontinued treatment due
to adverse events, possibly related to Val/Cel treatment. Among
those patients receiving Val/Cel, nausea was the most common
adverse event. The most common adverse events in the routine care
group were headaches and muscle pain.
Prevalence estimates suggest as many as 65
million people worldwide suffer Long-COVID sequelae, including
varying degrees of fatigue, cognitive problems, headache, sleep
disruption, myalgias, arthralgias, post-exertional malaise and
autonomic dysfunction/orthostatic intolerance.
Long-COVID related symptoms result in 2%-4% of
the US workforce being unable to work due to their illness,
resulting in an economic cost ranging from $170B-$230B, annually,
according to a 2022 Brookings Institute estimate.
“Improvements in Long-COVID patients’ related
fatigue, autonomic function and overall patient health status
suggest the potential for a combination of valacyclovir and
celecoxib as a new treatment option for COVID infected patients
whose symptoms persist for months, if not years, past their
recovery from the initial COVID illness,” said Lucinda Bateman, MD,
Founder and Medical Director of the Bateman Horne Center and the
study’s principal investigator.
“Given the lack of available treatments to
improve care for patients suffering from Long-COVID symptoms, these
encouraging results warrant progressing this unique combination
treatment into advanced development for post-viral syndromes,
including Long-COVID,” said R. Michael Gendreau, MD, PhD, Chief
Medical Officer of Virios Therapeutics. “We look forward to
engaging the Food and Drug Administration to discuss progressing
this novel treatment option into active Phase 2 clinical
development.”
About the Study
This open-label, single-center, 14-week
investigator-initiated study was designed to explore the safety and
efficacy of valacyclovir and celecoxib for the treatment of
symptoms associated with Post-Acute Sequelae of COVID-19 infection
(“PASC”) in adult female patients. Twenty-two female patients were
treated with twice daily doses of valacyclovir and celecoxib, which
is theorized to provide potent suppression of suspected
tissue-resident herpes viruses activated by prior infection with
the SARS-CoV-2 virus. The physiological response to tissue-resident
herpes virus activation is hypothesized to be causally related to
symptoms associated with PASC. A comparison cohort of seventeen
female Long-COVID patients matched by age and length of illness
were concurrently enrolled. The matched routine care group was
treated by the Bateman Horne Center providers or recruited from
alternative sites where patient care was provided by either their
primary care physician or another Long-COVID clinic health
professional.
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, myalgic
encephalomyelitis/chronic fatigue syndrome (“ME/CFS”), Post-Acute
Sequelae of COVID-19 (“PASC”) and other complex disorders, all of
which are characterized by multiple symptoms with no obvious
etiology. Our lead development candidates (“IMC-1” and “IMC-2”) are
novel, proprietary, fixed dose combinations of an antiviral
compound and celecoxib designed to synergistically suppress herpes
virus replication, with the end goal of reducing virally promoted
disease symptoms. IMC-1 (fixed dose combination of famciclovir and
celecoxib) has been granted fast track designation by the FDA. The
Company plans to engage the FDA in the latter half of 2023 with the
end goal of filing an investigational new drug application to
formally assess IMC-2 (fixed combination of valacyclovir and
celecoxib) as a potential treatment for PASC.
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
Source: Virios Therapeutics, Inc. (VIRI)
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