Revelation Biosciences Inc. Announces Safety Monitoring Committee Recommendation for Continuing Evaluation of REVTx-99b for the Treatment of Allergic Rhinitis
23 May 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 that the
independent Safety Monitoring Committee (SMC) reviewed data for 14
of patients treated in the Phase 1b clinical study of REVTx-99b for
the treatment of allergic rhinitis and patients with chronic nasal
congestion without polyps. Based on those findings, the SMC
recommended the continuation of the study without modification. The
clinical study is being conducted in Australia.
“The SMC's recommendation to continue enrollment
of the Phase 1b study, without modification, is an important
milestone for our lead drug candidate, REVTx-99b, as a potential
therapy for the millions of people who suffer from allergies that
cause symptoms of allergic rhinitis, also called hay fever, which
can lead to complications in some cases: nasal polyps, sinusitis,
and middle ear infections,” said James Rolke, Chief Executive
Officer of Revelation. “We are grateful to the patients and
investigators who have participated in study, and we look forward
to continuing the development of REVTx-99b”
The Phase 1b, randomized, double-blind,
placebo-controlled, crossover design study is expected to complete
enrollment in the third quarter of 2022. The primary endpoint is to
evaluate the effects of REVTx-99b 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
third quarter of 2022.
For more information on Revelation, please visit
www.RevBiosciences.com.
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 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, thereby reducing recruitment
of Th2 cells, and attenuating the allergic response.
Revelation is currently in a Phase 1b, randomized, double-blind,
placebo-controlled, crossover design study. The primary endpoint is
to evaluate the effects of REVTx-99b 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 company expects the
topline data in third quarter of 2022.
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 an 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 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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