Revelation Biosciences Has Completed Dosing of its First in Human Phase 1 Clinical Study of Gemini
13 Giugno 2024 - 3:21PM
Business Wire
-Top-line data forthcoming-
Revelation Biosciences, Inc. (NASDAQ: REVB) (the “Company” or
“Revelation”), a clinical-stage life sciences company that is
focused on harnessing the power of trained immunity for the
prevention and treatment of disease, announced today that it has
completed enrollment and dosing of its first in human Phase 1
clinical study (RVL-HV02). The study, which was conducted in
Australia, evaluated escalating doses of intravenously administered
Gemini and enrolled 40 healthy individuals 18 to 55 years of age.
The forthcoming top-line data will include primary end points of
safety and tolerability along with exploratory endpoints including
multiple biomarkers of activity to demonstrate stimulation of the
innate immune response. If positive, the data from this Phase 1
clinical study will support future program development of Gemini
across multiple indications.
Gemini is the Company’s proprietary formulation of
phosphorylated hexaacyl disaccharide (PHAD®), a toll-like receptor
4 (TLR4) agonist. TLR4 stimulation with PHAD potentially
preconditions the innate immune system to respond to a subsequent
stress, such as ischemia (loss of blood flow) or bacterial
infection. Gemini is initially being developed for two target
indications: as a pretreatment to prevent or reduce the severity of
acute kidney injury (AKI) due to cardiac surgery and as a
pretreatment to reduce the incidence, duration, and severity of
post-surgical infection. Preclinical studies using models of AKI
have demonstrated pretreatment with Gemini can reduce the severity
and duration of AKI. Additionally, preclinical studies using models
of bacterial infection have demonstrated pretreatment with PHAD can
reduce the overall rate and severity of infection.
“We are grateful to our investigator and the participants who
enrolled in this study,” said James Rolke, Chief Executive Officer
of Revelation. “Completion of our Phase 1 enrollment is a
significant milestone for the advancement of Gemini to address
multiple critical unmet needs, and we are looking forward to
announcing the forthcoming topline safety and activity data
soon.”
For more information on Revelation, please visit
www.RevBiosciences.com.
About Gemini
Gemini is a proprietary formulation of phosphorylated hexaacyl
disaccharide (PHAD®) for systemic administration. It is being
developed for multiple indications including as a pretreatment to
prevent or reduce the severity and duration of post-surgical
infection (GEMINI-PSI program), as pretreatment to prevent or
reduce the severity and duration of acute kidney injury (GEMINI-AKI
program). In addition, Gemini may be a treatment to stop or slow
the progression of chronic kidney disease (GEMINI-CKD program).
Revelation believes Gemini works through trained immunity, which
redirects and attenuates the innate immune response to external
stress (infection, trauma, etc.). Revelation has conducted multiple
preclinical studies demonstrating the therapeutic potential of
Gemini in the target indications.
About Revelation Biosciences, Inc.
Revelation Biosciences, Inc. is a clinical stage 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 as a prevention for post-surgical
infection, as a prevention for acute kidney injury, and for the
treatment of chronic kidney disease.
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
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 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240613954056/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
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