Revelation Biosciences Inc. (Revelation), a clinical-stage life
sciences company that is focused on the development of
immunologic‑based therapies for the prevention and treatment of
disease, announced today the site initiation for its Phase 2b viral
challenge study (RVL-VRL01) to evaluate the efficacy of intranasal
REVTx-99 for the preventive treatment of H3N2 influenza (influenza
A) in healthy humans. The study is being conducted in Belgium and
is enrolling healthy individuals 18 to 55 years of age.
REVTx-99 activates a nonspecific immune response
(innate) which differentiates it from most current treatments
focused on a specific immune response (adaptive) potentially
allowing for broader use in most infectious viruses. The viral
challenge study is the next necessary step in clinical development
of REXTx-99 for the treatment of respiratory viral infections.
Future development plans include clinical studies in SARS-CoV-2 and
its variants, along with other respiratory viruses.
“Respiratory viral infections including COVID-19
and influenza continue to be a huge social and economic burden
leading to more doctor visits and absenteeism from school and work
than any other illness. For influenza, 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,” said James Rolke, Chief Executive Officer of
Revelation. “The start of our viral challenge study is an important
step in bringing a potential new therapy to bear on this
problem.”
The Phase 2b, randomized, double-blind,
placebo-controlled study will enroll up to 60 participants. The
primary endpoint is to evaluate the efficacy of REVTx-99 in
reducing influenza virus load in the upper airways during
infection. Key secondary endpoints include: area under the curve
(AUC) of total symptom score, duration of symptoms, peak symptom
score, peak viral load, duration of influenza virus presence,
incidence of mild to moderate influenza disease (MMID) and
incidence of seroconversion.
The study will have two randomized cohorts.
Efficacy of the interventional strategies shall be assessed by
measuring the incidence and severity of the disease in the active
treatment groups compared to the placebo group along with
parameters of safety associated with adverse events and airway
physiology.
Revelation expects the topline data in the
second quarter 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 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 (REVID™), 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 recently announced that it has
entered into a definitive merger agreement (Merger Agreement) with
Petra Acquisition, Inc. (NASDAQ: PAICU, PAIC, & PAICW), a
special purpose acquisition company, for a business combination
that will result in Revelation becoming a publicly traded company
(Business Combination). The merger is expected to close in Q4 2021.
After the close of the merger the combined company will be listed
on NASDAQ under the ticker symbol “REVB.”
For more information on Revelation, please visit
www.RevBiosciences.com.
About Petra Acquisition,
Inc.
Petra Acquisition, Inc. (NASDAQ: PAICU, PAIC,
& PAICW) is a blank check company organized for the purpose of
effecting a merger, share exchange, asset acquisition, stock
purchase, recapitalization, reorganization or other similar
business combination with one or more businesses or entities, with
an initial focus on target businesses in the healthcare or a
healthcare-related industry.
Forward-Looking Statements
This press release contains forward-looking
statements as defined in the Private Securities Litigation Reform
Act of 1995, as amended, including statements regarding the
anticipated benefits of the transaction, the anticipated timing of
the transaction, the future business and financial condition of the
company post-closing and expected financial impacts of the
transaction, the satisfaction of closing conditions to the
transaction, the level of redemptions of Petra’s public
stockholders; the market opportunities for Revelation’s product
candidates; and the potential for regulatory approval for
Revelation’s product candidates. These forward-looking statements
are generally identified by the words "anticipate", "believe",
"expect", "estimate", "plan", "outlook", and "project" and other
similar expressions. Forward-looking statements are statements that
are not historical facts. We caution investors that forward-looking
statements are based on management’s expectations and are subject
to various risks and uncertainties. As a result, caution must be
exercised in relying on 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: risks relating to
the successful completion of RVL-CLR01 clinical study; the risk
that we may not fully enroll our RVL-CLR01 clinical study 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 RVL-CLR01 clinical study;
the occurrence of any event, change or other circumstances that
could give rise to an amendment or termination of the Merger
Agreement and the proposed transaction contemplated thereby; the
inability to complete the transactions contemplated by the Merger
Agreement due to the failure to obtain approval of the stockholders
of Petra or Revelation or other conditions to closing in the Merger
Agreement; the inability to project with any certainty the amount
of cash proceeds remaining in the Petra trust account at the
closing of the transaction; the uncertainty relative to the cash
made available to Revelation at the closing as a result of
redemption requests be made by the Petra stockholders; the
inability of the company post-closing to obtain or maintain the
listing of its securities on Nasdaq following the Business
Combination; the amount of costs related to the Business
Combination; Revelation’s ability to yield sufficient cash proceeds
from the transaction to support its short-term operations and
research and development efforts since the Merger Agreement
requires no minimum level of funding in the trust fund to close the
transaction; the outcome of any legal proceedings that may be
instituted against the parties following the announcement of the
Business Combination; changes in applicable laws or regulations;
the ability of Revelation to meet its post-closing financial and
strategic goals, due to, among other things, competition; the
ability of the company post-closing to grow and manage growth
profitability and retain its key employees; the possibility that
the company post-closing 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; 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 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 Petra.
No Offer or Solicitation
This press release shall not constitute an offer
to sell or the solicitation of an offer to buy any securities, nor
shall there be any sale of securities in any states or
jurisdictions in which such offer, solicitation, or sale would be
unlawful prior to registration or qualification under the
securities laws of any such jurisdiction. No offering of securities
shall be made except by means of a prospectus meeting the
requirements of Section 10 of the Securities Act, or an exemption
therefrom.
Important Information and Where to Find
It
In connection with the proposed Business
Combination described herein, Petra has filed relevant materials
with the SEC, including a Registration Statement on Form S-4, that
includes a preliminary proxy statement/prospectus, and when
available, will file a definitive proxy statement and final
prospectus. Promptly after filing its definitive proxy statement
with the SEC, Petra will mail the definitive proxy statement and a
proxy card to each stockholder entitled to vote at the Special
Meeting relating to the transaction. INVESTORS AND STOCKHOLDERS OF
PETRA ARE URGED TO READ THESE MATERIALS (INCLUDING ANY AMENDMENTS
OR SUPPLEMENTS THERETO) AND ANY OTHER RELEVANT DOCUMENTS IN
CONNECTION WITH THE TRANSACTION THAT PETRA WILL FILE WITH THE SEC
WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT
INFORMATION ABOUT PETRA, REVELATION AND THE BUSINESS COMBINATION.
The definitive proxy statement, the preliminary proxy statement and
other relevant materials in connection with the transaction (when
they become available), and any other documents filed by Petra with
the SEC, may be obtained free of charge at the SEC’s website
(www.sec.gov).
Participants in the
Solicitation
Petra and its directors and executive officers
may be deemed participants in the solicitation of proxies from
Petra’s stockholders with respect to the Business Combination. A
list of the names of those directors and executive officers and a
description of their interests in Petra will be included in the
proxy statement for the proposed Business Combination and be
available at www.sec.gov. Additional information regarding the
interests of such participants will be contained in the proxy
statement for the proposed Business Combination when available.
Information about Petra’s directors and executive officers and
their ownership of Petra common stock is set forth in Petra’s
prospectus, dated October 7, 2020, as modified or supplemented by
any Form 3 or Form 4 filed with the SEC since the date of such
filing. Other information regarding the interests of the
participants in the proxy solicitation will be included in the
proxy statement pertaining to the proposed Business Combination
when it becomes available. These documents can be obtained free of
charge at the SEC’s website (www.sec.gov).
Revelation and its directors and executive
officers may also be deemed to be participants in the solicitation
of proxies from the stockholders of Petra in connection with the
proposed Business Combination. A list of the names of such
directors and executive officers and information regarding their
interests in the proposed Business Combination will be included in
the proxy statement for the proposed Business Combination.
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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