Revelation Biosciences Inc. Announces Topline Data for Phase 1b CLEAR Clinical Study of REVTx-99b for the Treatment of Allergic Rhinitis
23 July 2022 - 8:30AM
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, today announced topline data
for its Phase 1b CLEAR clinical study to evaluate the effect of
intranasal REVTx-99b on nasal challenge allergen in participants
with allergic rhinitis to rye grass pollen.
The primary endpoint to evaluate the effects of
REVTx-99b versus placebo on safety and tolerability was met.
Exploratory endpoints for efficacy were not met. This includes no
reduction in allergy symptoms (Total Nasal Symptom Score) and no
increase in peak nasal inspiratory flow versus placebo. The study
enrolled two cohorts: one cohort received study drug prior to nasal
allergen challenge (the prophylactic cohort) and the second cohort
received study drug after the nasal allergen challenge (the
treatment cohort). The Phase 1b, randomized, double-blind,
placebo-controlled, crossover study design was conducted in
Australia. Revelation management plans to evaluate future
development of this and other ongoing programs.
About REVTx-99b
REVTx-99b is a proprietary intranasal
formulation in development for management of allergic rhinitis
symptoms including chronic nasal congestion. The active ingredient
has been shown in a Phase 1 clinical study to upregulate a protein,
which competes for the native eotaxin receptor, CCR3, preventing
eotaxin from recruiting eosinophils and basophils, thereby reducing
recruitment of Th2 cells, and attenuating the allergic
response.
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 multiple product candidates in development.
REVTx-99b, the lead therapeutic candidate, is being developed for
allergic rhinitis. 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. Revelation has engaged MedWorld Advisors to
facilitate partnering of the REVDx-501 asset. REVTx-200 is an
intranasal immunomodulator adjunct to be used in combination with a
traditional intramuscular vaccination for more complete
immunity.
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 successfully complete
planned clinical studies of its product candidates; 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 its 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; investor sentiment relating to SPAC related
going public transactions; 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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