Revelation Biosciences Inc. Announces Primary Endpoint Analysis for Phase 2b Viral Challenge Study to Assess Efficacy of Intranasal REVTx-99a for the Prevention of H3N2 Influenza Infection
31 March 2022 - 12:00AM
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, announces results from interim
statistical analysis for its Phase 2b viral challenge study
(RVL-VRL01) to evaluate the efficacy of intranasal REVTx-99a for
the preventive treatment of H3N2 influenza (influenza A) in healthy
humans. The study was conducted in Belgium and enrolled 30 healthy
individuals 18 to 55 years of age who were quarantined for 14 days
while participating in the study. An independent, unblinded subject
matter expert panel reviewed the interim results. Based on analysis
of the 30 patients through day 11 (day of discharge from the
clinical unit), there were no serious adverse events reported or
discontinuations due to study drug, and all subjects completed the
treatment period per protocol. Efficacy data demonstrated that
REVTx-99a did not meet its primary endpoint, area under the curve
(AUC) of viral load by quantitative RT-PCR from nasopharyngeal
swabs, and the preliminary results suggest the difference between
REVTx-99a and placebo was not statistically significant.
“While we are disappointed in the outcome of
this study, I would like to thank the study participants, the
Revelation team, and the clinical research organization for
conducting a well-executed study,” said James Rolke, Chief
Executive Officer of Revelation. “We remain committed to the
development of our other product candidates including REVTx-99b for
management of allergic rhinitis and other underlying conditions;
and REVDx-501, our universal at home screening test for respiratory
viral infection.”
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,
IP10, 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 second half 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 chronic nasal congestion. 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. 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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