Virios Therapeutics Announces Plans to Advance Lead Candidate IMC-1 to Phase 3 Development as a New Treatment Option for Fibromyalgia
09 8월 2023 - 8:05PM
Virios Therapeutics, Inc. (Nasdaq: VIRI) (the “Company”), a
development-stage biotechnology company focused on advancing novel
antiviral therapies to treat debilitating chronic diseases such as
fibromyalgia (“FM”) and Long-COVID, today announced that the Food
& Drug Administration (“FDA”) communicated that, following
their initial review of the Company’s chronic toxicology program,
the program’s studies appear adequate to support the safety of
IMC-1 at the dose proposed by the Company for chronic use. With
this critical feedback in hand, the Company plans to initiate its
proposed pharmacokinetic and food effect study (“pK”) this year,
while concurrently resubmitting a final Phase 3 program outline and
study protocols for FDA review. Following completion of the pK
study, the goal will be to begin enrollment in the first
fibromyalgia Phase 3 safety and efficacy study in mid-2024.
Key Highlights and Upcoming
Milestones
- The Company
plans to execute the pK study in males and females as a precursor
to the FM studies with an updated IMC-1 dose and formulation, which
is intended to enable the Company to take advantage of all of the
efficiencies afforded with utilization of the 505(b)(2) regulatory
pathway.
- Consistent with
the previously proposed Phase 3 plan, the Company will concurrently
submit its final Phase 3 program outline and associated study
protocols to FDA, to progress the following:
- Two adequate and well-controlled
clinical studies; and
- A long-term extension trial to
support chronic administration of IMC-1.
- Based on the
results from its recently completed FORTRESS Phase 2b trial, the
Company has designed a Phase 3 development program targeting
community-based FM patients who have not participated in prior FM
trials.
“We look forward to initiating our pK study with
the updated formulation of IMC-1 while finalizing the protocols and
procedures required for Phase 3 development of IMC-1 as a treatment
for FM. The safety and efficacy results from the FORTRESS trial,
along with the chronic toxicology program results, have enabled us
to define a clinical trial program as well as a formulation and
dose of IMC-1 to enhance our chances for success,” said R. Michael
Gendreau, Chief Medical Officer of Virios Therapeutics.
The Company will share more information about
its FM Phase 3 program during its earnings update on Thursday,
August 10, 2023 at 8:30 a.m. ET.
About Virios Therapeutics
Virios Therapeutics (Nasdaq: VIRI) is a
development-stage biotechnology company focused on advancing novel
antiviral therapies to treat diseases associated with a viral
triggered abnormal immune response such as fibromyalgia (“FM”) and
Long-COVID. Overactive immune response related to activation of
tissue resident herpesvirus has been postulated to be a potential
root cause of chronic illnesses such as FM, irritable bowel
syndrome, Long-COVID, chronic fatigue syndrome and functional
somatic syndromes, all of which are characterized by a waxing and
waning manifestation of disease, often triggered by events which
compromise the immune system. Our lead development candidates are
novel, proprietary, fixed dose combinations of an antiviral
compound and celecoxib designed to synergistically suppress
herpesvirus 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 goal of filing an investigational new drug
application to formally assess IMC-2 (fixed combination of
valacyclovir and celecoxib) as a potential treatment for Long-COVID
sequelae.
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
Virios Therapeutics (NASDAQ:VIRI)
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