Revelation Biosciences, Inc. Completes the GMP Manufacture of Gemini Clinical Drug Supply
2024年11月12日 - 8:00PM
ビジネスワイヤ(英語)
Revelation Biosciences, Inc. (NASDAQ: REVB) (the “Company” or
“Revelation”), a clinical-stage biopharmaceutical company focused
on harnessing the power of trained immunity for the prevention and
treatment of disease, today announced it has successfully completed
the GMP manufacture of Gemini drug product to support anticipated
clinical studies in the United States. GMP compliant manufacturing
of Gemini is a pivotal requirement for an Investigational New Drug
(IND) application with FDA. The Company intends to utilize the
current supply of Gemini for the upcoming Phase 1b clinical trial
in chronic kidney disease (CKD) patients as well as future Phase 2
studies.
“We are pleased to have achieved this critical milestone for the
advancement of Gemini,” said James Rolke, Chief Executive Officer
of Revelation. “We look forward to starting our Phase 1b study in
CKD and anticipate top-line results including pharmacokinetic,
pharmacodynamic, and safety data in the first half of 2025.”
About Gemini
Gemini is an intravenously administrated, proprietary
formulation of phosphorylated hexaacyl disaccharide (PHAD®) that
reduces the damage associated with inflammation by reprogramming
the innate immune system to respond to stress (trauma, infection,
etc.) in an attenuated manner. Revelation has conducted multiple
preclinical studies demonstrating the therapeutic potential of
Gemini in the target indications. Earlier this year Revelation
announced positive Phase 1 clinical data for intravenous treatment
with Gemini. The primary safety endpoint was met in the Phase 1
study, and results demonstrated statistically significant
pharmacodynamic activity as observed through expected changes in
multiple biomarkers including upregulation of IL-10.
Gemini is being developed for multiple indications including as
a pretreatment to prevent or reduce the severity and duration of
acute kidney injury (GEMINI-AKI program), and as pretreatment to
prevent or reduce the severity and duration of post-surgical
infection (GEMINI-PSI program). In addition, Gemini may be a
treatment to stop or slow the progression of chronic kidney disease
(GEMINI-CKD program).
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/20241112208515/en/
Company Contact
Chester Zygmont, III Chief Financial Officer Revelation
Biosciences, Inc. Email: czygmont@revbiosciences.com
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