Revelation Biosciences Inc. Gives Oral Presentation at Advances in Critical Care Nephrology (AKI & CRRT 2024)
2024年3月13日 - 10:00PM
ビジネスワイヤ(英語)
– Prophylactic administration of Gemini
(Intravenous PHAD®) reduces tissue damage and improves kidney
function in a rat model of bilateral ischemic reperfusion induced
acute kidney injury (AKI) -
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 new
preclinical data on the potential therapeutic benefit of Gemini for
the prevention of acute kidney injury (AKI) that was presented at
the International Conference on Advances in Critical Care
Nephrology (AKI & CRRT 2024) taking place in San Diego on March
12-15, 2024. Gemini is the Company’s proprietary formulation of
phosphorylated hexaacyl disaccharide (PHAD®), a toll-like receptor
4 (TLR4) agonist, in development for prevention of AKI. A copy of
the presentation and poster presented at the AKI and CRRT 2024
Conference can be found on Revelation’s website.
Results from Bilateral Rat Model of Ischemia Reperfusion
Induced AKI
In a clinically relevant bilateral rat model of ischemia
reperfusion (I/R) induced acute kidney injury (AKI), animals were
dosed intravenously with PHAD at 0.07 or 0.35mg/kg at 24 hours
and/or 48 hours prior to I/R surgery. In addition to clinical
observation, rats were evaluated for markers of kidney function at
24 and/or 72 hours post-surgery, and markers of kidney damage at 72
hours post-surgery.
In this model, Gemini pretreatment (0.35mg/kg)
significantly:
- Preserved kidney function with a more rapid return to base line
relative to untreated control animals, with statistically
significant reductions in serum creatinine (p<0.01 at 24 hours,
p<0.02 at 72 hours) and serum blood urea nitrogen (BUN)
(p<0.02 at 72 hours).
- Reduced overall damage (necrosis) of the cortical (p<0.02)
and medullary tubules (p<0.01) relative to the untreated
group.
- Significantly reduced markers of local inflammation at 24
and/or 72 hours as measured by concentrations of urinary and serum
c-reactive protein (CRP) (p<0.01) and IL-6 (p<0.05).
- Significantly reduced markers of cellular inflammation as
observed via reduced neutrophilic inflammation with a single dose
of 0.35mg/kg (p<0.02).
The improved kidney function, reduced necrosis and reduced
inflammatory biomarkers observed in this study are attributed to
the immunostimulatory preconditioning effect of Gemini which
includes strong upregulation of IL-10, a key cytokine responsible
for resolution of inflammation.
“These results demonstrate that Gemini has the potential to
reduce tissue damage and improve kidney function in ischemic
reperfusion induced acute kidney injury and potentially other
inflammatory diseases,” said James Rolke, Chief Executive Officer
of Revelation. “In addition to this, we are excited to have
initiated our Phase 1 clinical study with Gemini in February 2024
and we look forward to starting studies in patients later this
year.”
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-SSI program), and 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 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 GEMINI-SSI as a prevention for post-surgical infection,
GEMINI-AKI as a prevention for acute kidney injury, and GEMINI-CKD
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/20240313589805/en/
Company Contacts 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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