Gemini Induces Pharmacologic Activity and Related Physiologic Changes in Multiple Preclinical Studies
2023年10月12日 - 10:00PM
ビジネスワイヤ（英語）
- Key Biomarker Activity Confirmed for
Evaluation in Upcoming Phase 1 Study -
Revelation Biosciences Inc. (NASDAQ: REVB) (the “Company” or
“Revelation”), announced today that data from recent preclinical
studies of the Company’s Gemini formulation demonstrated its
therapeutic potential as a preventative therapy across multiple
indications including infection and acute kidney injury. Data,
discussed below, highlights the significant pharmacologic activity
following administration of Gemini in healthy animals. Additional
nonclinical biomarker analyses are ongoing in preparation for a
planned Phase 1 study to be initiated later this year. Further,
Revelation intends to publish the full results of these nonclinical
studies in conjunction with the upcoming data generated in the
Phase 1 healthy volunteer clinical study.
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Upregulation of key biomarkers were observed in both rodent and
non-rodent healthy animal preclinical studies. This included a dose
dependent migration of white blood cells (neutrophils, monocytes,
and lymphocytes) from the blood stream post dose with a subsequent
rebound at 24 hours (data for neutrophils in non-rodent model shown
in the figure below, n=3-10 per dose level examined). White blood
cell mobilization and activation plays an important role in the
prevention and resolution of bacterial infection.
In addition to having an effect on white blood cells, Gemini
produced a dose dependent increase in multiple cytokines of
interest including interleukin-10 (IL-10), neutrophil gelatinase
associated lipocalin (NGAL), and interleukin-6 (IL-6). Previously
on February 7, 2023 the Company announced results from a
preclinical study where administration of Gemini showed the
protective effect of IL-10 and NGAL upregulation on the formation
of kidney scar tissue in a validated preclinical model of acute and
chronic kidney injury.
IL-10 is characterized as an anti-inflammatory cytokine leading
to the ultimate resolution of inflammation. NGAL (and hepcidin,
data previously shown) sequester iron to prevent iron-mediated
reactive oxygen tissue damage associated with inflammation and
bacterial propagation by reducing available iron stores necessary
for bacterial growth. Initial upregulation of IL-6 is an important
first step to establish trained immunity. This phenomenon is
demonstrated after the administration of two doses of Gemini which
resulted in an initial increase in both inflammatory (IL-6) and
protective (IL-10) cytokines following a first dose. Then an
attenuated response in IL-6 following a second dose at 24 hours
(e.g. a smaller increase in inflammatory cytokines and a larger
increase in protective cytokines). This attenuated response in IL-6
demonstrates the premise of trained immunity and supports the
application of Gemini as a preconditioning treatment to prevent
excessive inflammation. The potential need for two doses to impart
protection against inflammation is currently being evaluated in a
preclinical model of acute kidney injury.
“We are delighted with the robust response observed following
Gemini administration and look forward to demonstrating a
comparable response in healthy human volunteers,” said James Rolke,
Chief Executive Officer of Revelation. “A strong response in the
Phase 1 study will be a very good indication of the potential of
Gemini to prevent and treat diseases such as hospital acquired
infection, acute kidney injury, chronic kidney disease and
myocarditis in patients who currently have limited options.”
About Gemini
Gemini is a proprietary formulation for systemic administration
of phosphorylated hexaacyl disaccharide (PHAD®) and is being
developed as a potential therapy for prevention and treatment of
hospital acquired infection (REVTx-100 program) and as a potential
treatment for acute and chronic organ disease including prevention
of acute kidney injury (REVTx-300 program), myocarditis, and
chronic kidney disease (CKD). Revelation believes Gemini works
through the process of trained immunity, comprising redirection and
attenuation of the innate immune system’s response to external
stress (infection, trauma, etc.). Revelation has conducted multiple
preclinical studies demonstrating the therapeutic potential of
Gemini in the target indications and plans to initiate clinical
studies in 2023.
About Revelation Biosciences Inc.
Revelation Biosciences, Inc. is a life sciences company focused
on harnessing the power of trained immunity for the prevention and
treatment of disease using its proprietary formulation Gemini.
Revelation has multiple ongoing programs to evaluate Gemini,
including REVTx-100 as a prevention for hospital acquired infection
and REVTx-300 as a prevention for acute kidney injury.
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20231012415267/en/
Sandra Vedrick Vice President, Investor Relations & Human
Resources Revelation Biosciences, Inc. Email:
svedrick@revbiosciences.com
and
Chester Zygmont, III Chief Financial Officer Revelation
Biosciences, Inc. Email: czygmont@revbiosciences.com
Revelation Biosciences (NASDAQ:REVB)
過去 株価チャート
から 11 2024 まで 12 2024
Revelation Biosciences (NASDAQ:REVB)
過去 株価チャート
から 12 2023 まで 12 2024
