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, is pleased
to announce that world renowned inflammasome researchers and
inventors of ZyVersa’s Inflammasome ASC Inhibitor IC 100 have
published a scientific paper in the peer-reviewed journal, Brain
Pathology. The researchers are from the University of Miami Miller
School of Medicine.
In the paper titled, “Identification of inflammasome signaling
proteins in neurons and microglia in early and intermediate stages
of Alzheimer’s disease,” the researchers observed expression of the
inflammasome NLRP1 sensor mainly in neurons, while inflammasome
sensor NLRP3 was detected mainly in microglia of donors with low
and intermediate AD pathology. The confirmation of these
inflammasomes in specific cell types during early stages of
neurodegeneration in AD bolsters evidence for the role of a
pathogenic inflammatory response in the disease, and the role of a
diverse set of inflammasomes in the disease process. The research
also demonstrated that ZyVersa’s Inflammasome ASC Inhibitor IC 100,
which inhibits multiple types of inflammasomes and ASC specks to
block initiation and perpetuation of damaging inflammation, has the
potential to identify neurons in the brains of patients with early
stages of AD, and the potential to serve as an early therapeutic
intervention.
“Inflammasome activation is implicated in the early stages of
AD, but the cell types that express inflammasomes have remained
undefined. This study demonstrates that IC 100 identifies neurons
in areas of the brain that are particularly susceptible to death in
the early and intermediate stages of the disease process. These
findings offer potential for developing imaging studies that will
identify inflammatory neurons in the early stages of AD,” said Dr.
Regina T. Vontell, Research Assistant Professor and Associate
Director, Brain Endowment Bank at the University of Miami Miller
School of Medicine.
“The reported data, combined with our earlier data demonstrating
that IC 100 decreases inflammasome activation and ASC speck
formation in aging mice, suggest that IC 100 has potential to not
only identify early stages of AD, but also to control the chronic
neuroinflammation that contributes to AD and its progression early
in the disease process,” stated Dr. Robert W. Keane, Professor,
Physiology and Biophysics, Neurological Surgery and Microbiology,
and Immunology at the University of Miami Miller School of
Medicine.
Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO and
President, stated: “The research on AD published in Brain Pathology
provides additional support for the therapeutic potential of
ZyVersa’s proprietary monoclonal antibody inflammasome ASC
inhibitor, IC 100, in neurological diseases. Preclinical studies
have demonstrated reduced inflammatory activity and/or improved
outcomes in multiple sclerosis, age-related inflammation, spinal
cord injury, and two different models of brain injury.”
To review the publication, 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 attenuates
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
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 developed to
ameliorate renal lipid accumulation that damages the kidneys'
filtration system in patients with glomerular 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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