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 it has
observed significant decrease in viral load with prophylactic
treatment of REVTx-99 in three independent in vitro single
cell-based assay models of SARS-CoV-2 infection.
In addition, the company announced that they
have completed their business combination with Petra Acquisition,
Inc. and will trade under “REVB” and “REVBW” beginning today,
January 11, 2022.
How REVTx-99 Works
REVTx-99 binds to toll-like receptor 4 (TLR4),
stimulating and inducing host-directed factors that augment the
production of protective cytokines including interferons and
interferon-related proteins which contributes to the establishment
of an anti-viral state regardless of virus type, strain, or
variant.
The Studies and Findings
REVTx-99 was assessed for prophylactic
anti-viral activity against SARS-CoV-2 Delta infection in three
separate cell lines, each expressing sufficient levels of ACEII and
TLR4, receptors required to sufficiently demonstrate viral
infection as well as REVTx-99 activity, respectively.
- Human primary bronchial/tracheal
cells were expanded and treated with 250 nanograms per mL (ng/mL)
REVTx-99 one hour prior to infection. SARS-CoV-2 viral spike
protein was measured using a cell-based ELISA. Viral load was
reduced by more than 50% when compared to the non-treated viral
assay control.
- Human alveolar epithelial cells
(A549, Adenocarcinomic) were treated with 250 ng/mL REVTx-99 24
hours prior to infection. SARS-CoV-2 viral load was measured using
RT-qPCR. Viral load was reduced more than 50% when compared to the
non-treated viral assay control.
- Human lung epithelial cells
(Calu-3, Adenocarcinomic) were treated with REVTx-99 one hour prior
to infection. SARS-CoV-2 was measured using the plaque formation
assay, which detected SARS-CoV-2 plaque forming units (PFUs).
Treatment with REVTx-99 at 250ng/mL and 1000ng/mL reduced the
number of PFUs by 19%, and 29%, respectively, compared to the
non-treated viral control.
These studies were conducted on behalf of
Revelation by a third-party contract research laboratory
specializing in viral activity assays.
Revelation is continuing to develop and optimize in vitro and in
vivo models to define TLR4 stimulation in response to REVTx-99, and
identify a dose range for optimal anti-viral efficacy against
SARS-CoV-2, additional variants such as Omicron, and other viruses
including rhinovirus, respiratory syncytial virus, and influenza.
Additional in vitro anti-viral dose response results for REVTx-99
will be used to inform the design for our planned preclinical
studies.
"These results, along with our early clinical study results,
(Revelation study REV-NHV01), suggest REVTx-99 creates an
anti-viral state in relevant cell types and encourage us to
continue our work to demonstrate the anti-viral potential for
REVTx-99, especially considering the continuous introduction of new
variants, such as Omicron”, said James Rolke, Chief Executive
Officer of Revelation. “With new, more infective SARS-CoV-2
variants emerging, and the continued impact of COVID-19 on the
daily lives of people around the world, we remain focused on
rapidly advancing this urgently needed protective therapy to fill
the current unmet need."
During the 2019-2020 season, the CDC estimates
that influenza was associated with 38 million illnesses, 18 million
medical visits, 405,000 hospitalizations, and 22,000 deaths.
Globally, COVID-19 is responsible for more than 5 million deaths,
with thousands of people dying every day.
Revelation Biosciences, Inc. Publicly
Listed on the NASDAQ
Revelation has completed its
previously-announced business combination with Petra Acquisition,
Inc., a special purpose acquisition company. The transaction was
approved at a special meeting of the Petra stockholders on January
6, 2022 following unanimous approval by Revelation stockholders.
The common stock of the combined company will trade under “REVB”,
“REVBW”, and “REVBU” beginning today, January 11, 2022.
For more information on Revelation, please visit
www.RevBiosciences.com.
Investor Conference Call
Information
Revelation will host investor conference call
and webcast on January 11, 2022 at 4:30 p.m. Eastern Time. The
conference call can be accessed by dialing 877-815-0146 for
domestic callers and 631-625-3219 for international callers. Please
provide the operator with the passcode 1847899 to join the
conference call or click here for the webcast. An archive of the
conference call and webcast will be available on Revelation’s
website for 30 days following the call
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 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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