Revelation Biosciences Starts its PRIME Phase 1b Clinical Study of Gemini in CKD Patients
21 Januar 2025 - 12:00PM
Business Wire
– Dosing to Commence Mid-February –
– Topline data expected Mid-Year –
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 it has started its PRIME
(PReconditioning IMmunostimulatory Evaluation) Phase 1b clinical study of escalating
doses of intravenously administered Gemini in patients with Stage 3
and 4 Chronic Kidney Disease (CKD). The US based multi-site
placebo-controlled study will enroll up to forty patients in five
cohorts of single escalating doses.
“I am delighted to see the Revelation teams’ hard work
culminating with the start of the PRIME study.” said James Rolke,
Chief Executive Officer of Revelation. “We look forward to the
results and plan to educate the public over the next few months on
the importance of the planned biomarkers as it relates to CKD
treatment and prevention of AKI.”
Top-line data including safety, tolerability, and biomarkers of
target activity are expected by mid-year. Data from the PRIME
clinical study will support future development in both the GEM-CKD
and GEM-AKI programs.
About AKI
AKI, also known as acute renal failure, is defined as a rapid
loss of kidney function. AKI causes a build-up of waste products in
blood and makes it more difficult for kidneys to maintain the
correct balance of fluid in the body. AKI can also have a
significant impact on other organs such as the brain, heart, and
lungs.
About CKD
Chronic kidney disease is a pervasive problem in the United
States and world-wide. CKD is due to chronic inflammation and can
be initiated and propagated in several ways. One prevalent
condition is the high blood sugar levels associated with diabetes
(either Type 1 or Type 2). High blood sugar is toxic to kidney
cells creating stress which imitates the inflammatory process
leading to the demise of these cells with subsequent fibrosis
ultimately resulting in continuous loss of kidney function over
time. High arterial blood pressure is another source of stress that
initiates the inflammatory process leading to CKD. Other risk
factors include heart disease, obesity, family history of CKD or
older age. Progression of chronic kidney damage often leads to end
stage renal disease with the need for renal replacement therapy
(dialysis or transplantation), resulting in significant morbidity
and mortality for affected patients. Kidney diseases are the
leading cause of death in the United States.
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 (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/20250121688279/en/
Mike Porter Investor Relations Porter LeVay & Rose Inc.
Email: mike@plrinvest.com
Chester Zygmont, III Chief Financial Officer Revelation
Biosciences Inc. Email: czygmont@revbiosciences.com
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