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, today announced statistically
significant, dose dependent increases of interleukin-10 (IL-10) in
response to Gemini treatment, using a high sensitivity analysis.
This additional positive data follows the previously reported
positive topline data from the Phase 1 clinical study of Gemini
released on June 24, 2024.
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Figure 1. Upregulation of IL-10 at 2
Hours Post Intravenous Administration of Gemini (Graphic: Business
Wire)
Using high sensitivity serum IL-10 biomarker analysis to gain
further insight into Gemini’s capability for resolution of
inflammation, Revelation tested samples from the Phase 1 clinical
study. It was found that Gemini induced statistically significant,
dose dependent changes in circulatory IL-10 at 2 hours post-dose,
with a p-value of < 0.05 or greater, at each of the low, mid,
and high dose levels, as shown in Figure 1. The change in IL-10
observed for treatment groups relative to placebo, were a 27-fold
increase, 162-fold increase, and 309-fold increase for the low,
mid, and high dose groups, respectively.
IL-10 is a potent anti-inflammatory protein that downregulates
pro-inflammatory cytokines and is an active contributor to
initiating reduction of inflammation. The significant increase of
anti-inflammatory IL-10 with no significant increase in
pro-inflammatory IL-1β and TNF-α confirms TLR4 binding unique to
Gemini, and is further evidence of the reprogramming of the innate
immune response, enabling Gemini to initiate resolution of
inflammation and promote the healing process.
The observed increase of IL-10 in humans is consistent with
prior preclinical studies performed by Revelation where an increase
in IL-10 was observed in healthy animals as well as efficacy
models, including the ischemia/reperfusion model of acute kidney
injury and unilateral ureteral obstruction model of kidney injury.
This demonstrates the potential for Gemini in our target
indications, including prevention of AKI following cardiac
surgery.
“We are very pleased to see such a clear increase in
interleukin-10 levels. This confirms how we can use Gemini to fine
tune the innate immune response and speed the healing process
through immunostimulatory preconditioning,” said James Rolke, Chief
Executive Officer of Revelation. “This new data underlines the
potential benefit of Gemini for patients, and we are committed to
moving rapidly into our Phase 1b study in late 2024.”
For more information on Revelation, please visit
www.RevBiosciences.com.
About Gemini
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 as a single dose
preconditioning therapy for two target indications: as a
pretreatment to prevent or reduce the severity of acute kidney
injury due to cardiac surgery (GEMINI-AKI program) and as a
pretreatment to reduce the incidence, duration, and severity of
post-surgical infection (GEMINI-PSI program). In addition, Gemini
has the potential to be a long-term 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.). Preclinical studies evaluating
models of AKI or bacterial infection have demonstrated pretreatment
with Gemini can reduce the severity and duration of AKI or
bacterial infection, respectively. Additionally, preclinical
studies evaluating a model of CKD demonstrate the potential of
Gemini as a treatment to prevent kidney tissue scarring following
the onset of severe inflammation.
About the Phase 1 Study
The Phase 1 study enrolled 40 healthy individuals 18 to 55 years
of age, was conducted in Australia and evaluated escalating doses
(placebo, low, mid, and high dose) of intravenously administered
Gemini. The primary endpoint was to evaluate the safety and
tolerability of escalating doses of Gemini. Additionally, multiple
biomarkers of clinical activity were evaluated.
As previously reported, the primary endpoint to evaluate the
safety and tolerability of escalating doses of Gemini was met and a
maximum tolerated dose in healthy volunteers was identified. In
addition, Gemini administration engaged multiple beneficial markers
of the innate immune system, including mobilization of innate
immune cells, and increased IL-10, Interleukin-1 Receptor
Antagonist (IL-1RA), Neutrophil Gelatinase Associated Lipocalin
(NGAL), and relatively low levels of Interleukin-6 (IL-6).
Importantly, Gemini administration did not induce significant
increases in serum TNF-α or IL-1β, markers associated with
inflammatory damage.
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 prevention of post-surgical infection,
prevention of 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240924064564/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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