Revelation Biosciences Inc. (NASDAQ: REVB) (the “Company” or
“Revelation”), a clinical-stage life sciences company that is
focused on the development of immunologic‑based therapies for the
prevention and treatment of disease, outlines details on the
upcoming data analysis for Phase 2b viral challenge study
(RVL-VRL01) to evaluate the efficacy of intranasal REVTx-99a for
the preventive treatment of H3N2 influenza (influenza A) infection
in healthy humans. Dosing and enrollment for this study were
recently completed and primary endpoint analysis is expected early
Q2 2022, followed by final data analysis in Q2 2022.
The Phase 2b, randomized, double-blind,
placebo-controlled study was conducted in Belgium and enrolled
healthy individuals 18 to 55 years of age. The primary endpoint is
to evaluate the efficacy of REVTx-99a in reducing area under the
curve (AUC) influenza viral load in the upper airways during
infection as measured by RT-qPCR relative to placebo. The results
will inform if REVTx-99a is better, just as good, or worse than
placebo at controlling the amount of influenza virus in a person’s
body. Generally, the higher the amount of virus (viral load), the
more infected, and by conjunction, the sicker a person may be.
Reducing viral load is an indicator of clinical benefit and likely
to correlate with reduced symptoms.
Key secondary endpoints include AUC of total
symptom score, duration of symptoms, peak symptom score, peak viral
load, duration of influenza virus presence, incidence of mild to
moderate influenza disease (MMID), and incidence of
seroconversion.
REVTx-99a activates a nonspecific immune
response (a targeted, local innate response) which differentiates
it from most current treatments focused on a specific immune
response (an adaptive response), potentially enabling the use of
REVTx-99a for broader use across most infectious upper respiratory
viruses. The viral challenge study is the next necessary step in
clinical development of REVTx-99a for the treatment of respiratory
viral infections. Future development plans include clinical studies
in SARS-CoV-2 and its variants, along with other respiratory
viruses.
“We are excited to have completed enrollment and
dosing for this study and are grateful for the continued support of
our clinical trial site,” said James Rolke, Chief Executive Officer
of Revelation. “We are looking forward to sharing the data
soon.”
For more information on the design of the clinical study or
Revelation, please visit www.RevBiosciences.com.
About REVTx-99a, REVTx-99b and REVTx-200
The active ingredient in REVTx-99a, REVTx-99b
and REVTx-200 stimulates the nasal (mucosal) innate immune system
via interaction with toll-like receptor 4 (TLR4) to produce
protective cytokines including interferons and interferon-related
proteins. These protective cytokines can work in a variety of ways
including: to blunt the ability of an invading virus to proliferate
and survive (REVTx-99a), tamping down on the inflammatory response
(REVTx-99b), or recruiting the adaptive immune response
(REVTx-200).
REVTx-99a is a proprietary intranasal
formulation in development for the prevention or treatment of
respiratory viral infection and is broadly applicable to most
infectious viruses including influenza A, influenza B,
parainfluenza, rhinovirus, respiratory syncytial virus (RSV),
SARS-CoV-2, and its variants. Phase 1 data showed REVTx-99a to be
well-tolerated and to significantly increase intranasal protective
cytokines. In addition, REVTx-99a has been assessed for
prophylactic anti-viral activity in vitro against SARS-CoV-2 Delta
infection in three separate cell lines, each expressing sufficient
levels of ACEII and TLR4, receptors required to sufficiently
demonstrate viral infection as well as REVTx-99a activity,
respectively. In these in vitro studies, REVTx-99a resulted in a
significant decrease in viral load with prophylactic treatment.
REVTx-99b is a proprietary intranasal
formulation being developed for management of allergic rhinitis
symptoms. REVTx-99b upregulates a protein which competes for the
native eotaxin receptor, CCR3, preventing eotaxin from recruiting
eosinophils, thereby reducing recruitment of Th2 cells, and
attenuating the allergic response.
REVTx-200 is a proprietary formulation being
developed as an intranasal adjunct to intramuscular respiratory
vaccines to give a more complete immunization through recruitment
of the adaptive immune response into the nasal mucosal space.
About Revelation Biosciences Inc.
Revelation Biosciences, Inc. is a clinical-stage
life sciences company focused on the development of
immunologic-based therapies for the prevention and treatment of
disease. Revelation has several product candidates in development.
REVTx-99a, the lead therapeutic candidate, is an intranasal
immunomodulator to prevent or treat infections caused by various
respiratory viruses such as SARS-CoV-2, including its variants,
influenza A and B, parainfluenza, rhinovirus, and RSV. REVTx-99b is
being developed for other indications such as: allergic rhinitis
and chronic nasal congestion. REVTx-200 is an intranasal
immunomodulator adjunct to be used in combination with an
intramuscular vaccination for more complete immunity. REVTx-200 is
based on the same technology used in REVTx-99a and REVTx-99b. In
addition to Revelation’s therapeutic pipeline, Revelation is also
developing REVDx-501, a rapid home use diagnostic that can be used
to detect any respiratory viral infection, regardless of virus type
or strain, without the need for specialized instrumentation.
For more information on Revelation, please visit
www.RevBiosciences.com.
Forward-Looking Statements
This press release contains forward-looking
statements as defined in the Private Securities Litigation Reform
Act of 1995, as amended. Forward-looking statements are statements
that are not historical facts. These forward-looking statements are
generally identified by the words "anticipate", "believe",
"expect", "estimate", "plan", "outlook", and "project" and other
similar expressions. We caution investors that forward-looking
statements are based on management’s expectations and are only
predictions or statements of current expectations and involve known
and unknown risks, uncertainties and other factors that may cause
actual results to be materially different from those anticipated by
the forward-looking statements. Revelation cautions readers not to
place undue reliance on any such forward looking statements, which
speak only as of the date they were made. The following factors,
among others, could cause actual results to differ materially from
those described in these forward-looking statements: the ability of
Revelation to meet its financial and strategic goals, due to, among
other things, competition; the ability of Revelation to grow and
manage growth profitability and retain its key employees; the
possibility that the Revelation may be adversely affected by other
economic, business, and/or competitive factors; risks relating to
the successful development of Revelation’s product candidates; the
clinical utility of an increase in intranasal cytokine levels as a
biomarker of viral infections; the ability to complete planned
clinical studies of REVTx-99a, REVTx-99b; risks relating to the
successful completion of RVL-CLR01 and RVL-VRL01 clinical studies;
the risk that we may not fully enroll our clinical studies or
enrollment will take longer than expected; risks relating to the
occurrence of adverse safety events and/or unexpected concerns that
may arise from data or analysis from our clinical studies; changes
in applicable laws or regulations; expected initiation of the
clinical studies, the timing of clinical data; the outcome of the
clinical data, including whether the results of such study is
positive or whether it can be replicated; the outcome of data
collected, including whether the results of such data and/or
correlation can be replicated; the timing, costs, conduct and
outcome of our other clinical studies; the anticipated treatment of
future clinical data by the FDA, the EMA or other regulatory
authorities, including whether such data will be sufficient for
approval; the success of future development activities for
REVTx-99a, REVTx-99b and expanded indications, REVTx-200,
REVDx-501, or any other product candidates; potential indications
for which product candidates may be developed; the potential impact
that COVID-19 may have on Revelation’s suppliers, vendors,
regulatory agencies, employees and the global economy as a whole;
the ability of Revelation to maintain the listing of its securities
on NASDAQ; the expected duration over which Revelation’s balances
will fund its operations; and other risks and uncertainties
described herein, as well as those risks and uncertainties
discussed from time to time in other reports and other public
filings with the SEC by Revelation.
Company Contacts
Sandra VedrickVice President, Investor Relations & Human
ResourcesRevelation Biosciences Inc. Email:
svedrick@revbiosciences.com
and
Chester Zygmont, IIIChief Financial OfficerRevelation
Biosciences Inc. Email: czygmont@revbiosciences.com
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