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 that the first
patient has been enrolled and dosed in a Phase 1b clinical study to
evaluate the potential utility of REVTx-99 for treating patients
with allergic rhinitis and patients with chronic nasal congestion
without polyps. The clinical study is being conducted in Australia.
“In the US, approximately 8% of adults and 7% of
children have allergies that cause symptoms of allergic rhinitis,
also called hay fever, and patients with allergic rhinitis have a
threefold greater risk of developing asthma. The risk of developing
asthma increases with more severe and persistent allergic
rhinitis,” said James Rolke, Chief Executive Officer of Revelation.
“REVTx-99 is being developed as a therapy for the millions of
people who suffer from these symptoms each year – including those
related to chronic nasal congestion, in which patients with severe
cases may require invasive sinus surgery. The initiation of patient
enrollment is an important step in our efforts to provide patients
with safe and effective treatments for these chronic issues.”
The Phase 1b, randomized, double-blind,
placebo-controlled, crossover design study is expected to enroll
approximately 28 participants. The primary endpoint is to evaluate
the effects of REVTx-99 versus placebo on safety and tolerability.
Key secondary endpoints include allergy symptoms (Total Nasal
Symptom Score) and peak nasal inspiratory flow elicited by nasal
allergen challenge. The study will have two cohorts: one cohort
will receive study drug before the nasal allergen challenge (the
prophylactic cohort) and the second cohort will receive study drug
after the nasal allergen challenge (the treatment cohort).
The company expects the topline data in the
first half of 2022.
For more information on Revelation, please visit
www.RevBiosciences.com.
About REVTx-99
REVTx-99 is a proprietary intranasal drop 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.
The active ingredient in REVTx-99 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 work in
concert to blunt the ability of an invading virus to proliferate
and survive. Phase 1 data showed REVTx-99 to be well-tolerated and
to significantly increase intranasal protective cytokines.
In addition to viral infection, REVTx-99 is also
being developed for management of allergic rhinitis symptoms and
chronic nasal congestion without polyps. REVTx-99 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.
About Allergic Rhinitis
Allergic rhinitis also called hay fever, is a very common
disorder that affects millions of patients annually and the
hallmark complaint of nasal obstruction significantly impacts the
quality of life. It is an allergic reaction to tiny particles in
the air called allergens. Symptoms include sneezing, nasal
congestion and irritation of the nose, throat, mouth and eyes. Some
treatment options may include antihistamines, anti-inflammatory
nasal sprays, anti-leukotrienes, and surgery. Allergic rhinitis can
lead to complications in some cases: nasal polyps, sinusitis, and
middle ear infections. People with severe chronic nasal congestion
sometimes need surgery.
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-99, 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-99 is
also 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-99. 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-99; 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-99 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
Media contact: Kristin Faulder kristin@heurisay.com
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