ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical
stage specialty biopharmaceutical company developing first-in-class
drugs for treatment of inflammatory and renal diseases, announces
that world renowned inflammasome researchers from the University of
Miami Miller School of Medicine and inventors of Inflammasome ASC
Inhibitor IC 100 have published a scientific paper in the
peer-reviewed journal, Pharmaceuticals, highlighting how
inflammation in the brain mediated by traumatic injury can trigger
inflammation in the heart.
In the paper titled, “Neural–Cardiac Inflammasome Axis after
Traumatic Brain Injury,” the authors conducted a study in animal
models of TBI and evaluated serum from patients following TBI and
from healthy controls. Data indicate that pyrin
inflammasome-mediated inflammation induced by TBI contributes to
cardiovascular co-morbidities through systemic release of
proinflammatory mediators that activate AIM2 inflammasomes in the
heart leading to damaging inflammation. The role of inflammasome
activation in the development of TBI-induced cardiovascular
co-morbidities was substantiated by increased ASC speck formation
in the brains and hearts of TBI mouse models.
“A heightened systemic inflammatory response is often induced
after TBI, but the underlying pathomechanisms that contribute to
co-morbidities remain poorly understood. Here, we investigated
whether extracellular vesicles (EVs) containing inflammasome
proteins are released after severe controlled cortical impact in
C57BL/6 mice and cause activation of inflammasomes in the heart
that result in tissue damage,” said Dr. Robert W. Keane, Professor,
Physiology and Biophysics, Neurological Surgery and Microbiology,
and Immunology, University of Miami Miller School of Medicine. “TBI
resulted in the release of EVs into the serum, which contain a
cargo of inflammasome-, complement- and cardiovascular-related
signaling proteins, and adoptive transfer of EVs from TBI patients
resulted in inflammasome activation in cardiovascular cells.”
“Importantly, here, we also found an increase in ASC specks in
the brain and the heart of TBI mice, suggesting that these
prion-like ASC structures play a significant role in the
inflammatory pathogenesis observed after TBI in the brain and
systemically. Moreover, this finding emphasizes the potential
benefit of therapies targeting ASC specks after CNS injury,” stated
Dr. Juan Pablo de Rivero Vaccari, Associate Professor, Department
of Neurological Surgery, University of Miami Miller School of
Medicine. To review the paper, Click Here.
“This research published in the Journal, Pharmaceuticals, along
with recent research published in the Journal of Clinical
Investigation and Translational Research reinforces the importance
of attenuating extracellular propagation of IL-1β to minimize
induction and perpetuation of inflammation in surrounding tissues
and organs,” commented Stephen C. Glover, ZyVersa’s Co-founder,
Chairman, CEO, and President. “ZyVersa’s Inflammasome ASC inhibitor
IC 100 is designed to inhibit formation of multiple types of
inflammasomes to attenuate initiation of the inflammatory cascade,
and to inhibit their associated ASC specks to reduce perpetuation
of damaging inflammation.”
To review a white paper summarizing the mechanism of action and
preclinical data for IC 100, Click Here.
About Inflammasome ASC Inhibitor IC 100
IC 100 is a novel humanized IgG4 monoclonal antibody that
inhibits the inflammasome adaptor protein ASC. IC 100 was designed
to attenuate both initiation and perpetuation of the inflammatory
response. It does so by binding to a specific region of the ASC
component of multiple types of inflammasomes, including NLRP1,
NLRP2, NLRP3, NLRC4, AIM2, Pyrin. Intracellularly, IC 100 binds to
ASC monomers, inhibiting inflammasome formation, thereby blocking
activation of IL-1β early in the inflammatory cascade. IC 100 also
binds to ASC in ASC Specks, both intracellularly and
extracellularly, further blocking activation of IL-1β and the
perpetuation of the inflammatory response that is pathogenic in
inflammatory diseases. Because active cytokines amplify adaptive
immunity through various mechanisms, IC 100, by attenuating
cytokine activation, also attenuates the adaptive immune
response.
About ZyVersa Therapeutics, Inc.
ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty
biopharmaceutical company leveraging advanced, proprietary
technologies to develop first-in-class drugs for patients with
renal and inflammatory diseases who have significant unmet medical
needs. The Company is currently advancing a therapeutic development
pipeline with multiple programs built around its two proprietary
technologies – Cholesterol Efflux Mediator™ VAR 200 for treatment
of kidney diseases, and Inflammasome ASC Inhibitor IC 100,
targeting damaging inflammation associated with numerous CNS and
other inflammatory diseases. For more information, please visit
www.zyversa.com.
Cautionary Statement Regarding Forward-Looking
Statements
Certain statements contained in this press release regarding
matters that are not historical facts, are forward-looking
statements within the meaning of Section 21E of the Securities
Exchange Act of 1934, as amended, and the Private Securities
Litigation Reform Act of 1995. These include statements regarding
management’s intentions, plans, beliefs, expectations, or forecasts
for the future, and, therefore, you are cautioned not to place
undue reliance on them. No forward-looking statement can be
guaranteed, and actual results may differ materially from those
projected. ZyVersa Therapeutics, Inc (“ZyVersa”) uses words such as
“anticipates,” “believes,” “plans,” “expects,” “projects,”
“future,” “intends,” “may,” “will,” “should,” “could,” “estimates,”
“predicts,” “potential,” “continue,” “guidance,” and similar
expressions to identify these forward-looking statements that are
intended to be covered by the safe-harbor provisions. Such
forward-looking statements are based on ZyVersa’s expectations and
involve risks and uncertainties; consequently, actual results may
differ materially from those expressed or implied in the statements
due to a number of factors, including ZyVersa’s plans to develop
and commercialize its product candidates, the timing of initiation
of ZyVersa’s planned preclinical and clinical trials; the timing of
the availability of data from ZyVersa’s preclinical and clinical
trials; the timing of any planned investigational new drug
application or new drug application; ZyVersa’s plans to research,
develop, and commercialize its current and future product
candidates; the clinical utility, potential benefits and market
acceptance of ZyVersa’s product candidates; ZyVersa’s
commercialization, marketing and manufacturing capabilities and
strategy; ZyVersa’s ability to protect its intellectual property
position; and ZyVersa’s estimates regarding future revenue,
expenses, capital requirements and need for additional
financing.
New factors emerge from time-to-time, and it is not possible for
ZyVersa to predict all such factors, nor can ZyVersa assess the
impact of each such factor on the business or the extent to which
any factor, or combination of factors, may cause actual results to
differ materially from those contained in any forward-looking
statements. Forward-looking statements included in this press
release are based on information available to ZyVersa as of the
date of this press release. ZyVersa disclaims any obligation to
update such forward-looking statements to reflect events or
circumstances after the date of this press release, except as
required by applicable law.
This press release does not constitute an offer to sell, or the
solicitation of an offer to buy, any securities.
Corporate and IR Contact:Karen CashmereChief
Commercial
Officerkcashmere@zyversa.com786-251-9641
Media ContactsTiberend Strategic Advisors,
Inc.Casey McDonaldcmcdonald@tiberend.com646-577-8520
Dave Schemeliadschemelia@tiberend.com609-468-9325
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