Revelation Biosciences Inc. Completes Database Lock for its Phase 1b CLEAR Clinical Study of REVTx-99b for the Treatment of Allergic Rhinitis
14 July 2022 - 11:00PM
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 data base lock
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. Topline data is
expected in the last week of July 2022.
The Phase 1b, randomized, double-blind,
placebo-controlled, crossover study design was conducted in
Australia. The primary endpoint is to evaluate the effects of
REVTx-99b versus placebo on safety and tolerability. Key
exploratory endpoints include allergy symptoms (Total Nasal Symptom
Score) and peak nasal inspiratory flow elicited by nasal allergen
challenge. 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).
Allergic rhinitis, or hay fever, is an allergic
reaction to tiny particles in the air called allergens. It is a
common disorder that affects millions of patients annually and
significantly impacts quality of life. Symptoms include sneezing,
nasal congestion, and irritation of the nose, throat, mouth, and
eyes. Allergic rhinitis can lead to complications in some cases
including nasal polyps, sinusitis, and middle ear infections.
People with severe chronic nasal congestion sometimes require
surgery. While multiple treatment options are available, many of
these still have limited efficacy in preventing symptoms, and may
be associated with unwanted side-effects, thus better therapies are
still needed.
“We are delighted to have the database lock
completed in a timely and efficient manner and look forward to
reporting the results soon,” said James Rolke, Chief Executive
Officer of Revelation. “This is an important milestone taking us
one step further in the development of a treatment for patients who
suffer from allergic rhinitis – including patients with severe
cases that may require invasive sinus surgery.”
For more information on Revelation, please visit
www.RevBiosciences.com.
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, and is currently being evaluated as a treatment
for allergic rhinitis in a Phase 1b CLEAR study. Topline results
are expected in the third quarter of 2022. 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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