Revelation Biosciences Inc. Announces FDA Acceptance of Gemini IND
2024年12月2日 - 8:00PM
ビジネスワイヤ（英語）
-Phase 1b Study in CKD Patients to begin
early 2025-
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
treatment of disease, announced today that the United States Food
and Drug Administration (FDA) has accepted its investigational new
drug (IND) application for Gemini. This game changing milestone
allows the Company to initiate its US based Phase 1b clinical study
to evaluate the potential of Gemini as a preconditioning treatment
in patients with chronic kidney disease (CKD).
The multi-site, placebo-controlled Phase 1b clinical study will
enroll up to 40 subjects in up to 5 cohorts. The primary endpoint
is evaluation of the safety and tolerability of a single dose of
Gemini in patients with CKD. Secondary and exploratory endpoints
will assess the pharmacokinetics, and the potential of Gemini to
mobilize and attenuate the innate immune response to stress by
measuring several predictive biomarkers of efficacy.
Positive data from the Phase 1b study will enable a Phase 2
study of Gemini as a preconditioning treatment in patients with CKD
to reduce the incidence, duration, and severity of acute kidney
injury (AKI) in patients undergoing coronary artery bypass graft
(CABG) and/or cardiac valve surgery.
“We are proud to receive acceptance of our IND for Gemini,
marking our most important milestone to date for Revelation,” said
James Rolke, Chief Executive Officer of Revelation. “By leveraging
the unique properties of trained immunity, we are exploring new
ways to improve patient outcomes. We will continue to move swiftly
to initiate our Phase 1b clinical study in the near future.”
For more information on Revelation, please visit
www.RevBiosciences.com.
About Gemini
Gemini is an intravenously administrated, proprietary
formulation of phosphorylated hexaacyl disaccharide (PHAD®) that
reduces the damage associated with inflammation by reprograming the
innate immune system to respond to stress (surgery, 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 has potential
as 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 acute kidney injury,
as a prevention for post-surgical infection, 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/20241202245006/en/
Company Contacts
Chester Zygmont, III Chief Financial Officer Revelation
Biosciences Inc. Email: czygmont@revbiosciences.com
Revelation Biosciences (NASDAQ:REVB)
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