ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA; “ZyVersa”), a clinical
stage specialty biopharmaceutical company developing first-in-class
drugs for treatment of patients with inflammatory and renal
diseases who have significant unmet medical needs, announces
availability of a new white paper on the critical role of
inflammasome ASC in the development and progression of a wide-range
of inflammatory diseases. Data suggest that drugs targeting ASC may
provide the best opportunity to control damaging inflammation
associated with diseases affecting millions of people worldwide.
The white paper titled, “Inflammasome ASC: A Promising Therapeutic
Target,” can be accessed by Clicking Here.
The white paper highlights groundbreaking research from the labs
of Drs. Bramlett, de Rivero Vaccari, Dietrich, and Keane, pioneers
in the field of inflammasomes and members of ZyVersa’s Scientific
Advisory Board. To read their biographies, Click Here.
“After 15 years of research to develop an understanding of how
inflammasomes contribute to so many diverse diseases and
conditions, we discovered the critical role of the ASC component
and developed a monoclonal antibody, known as Inflammasome ASC
Inhibitor IC 100,” stated Dr. Keane. “ASC is central to formation
and activation of multiple inflammasome complexes associated with
numerous diseases. ASC forms a large filamentous structure, the ASC
speck, which is released from cells, amplifying and perpetuating
inflammation. We believe that targeting ASC provides the best
opportunity to control damaging inflammation.”
Dr. de Rivero Vaccari added, “We have studied IC 100 in animal
models of diverse diseases and injuries including multiple
sclerosis, age-related inflammation associated with
neurodegenerative diseases, Alzheimer’s disease, acute respiratory
distress syndrome, traumatic brain injury, and spinal cord injury.
Each of these conditions demonstrated that IC 100 inhibited
inflammasome activation, which resulted in improved histopathology
and/or improved functional outcomes. We are continuing our research
in other diseases, including Parkinson’s disease, for which we were
awarded a grant from the Michael J. Fox Foundation.”
“ZyVersa, which obtained a worldwide license for Inflammasome
ASC Inhibitor IC 100, is honored to collaborate with Drs. Bramlett,
de Rivero Vaccari, Dietrich, and Keane to advance development of IC
100 into human trials,” said Stephen C. Glover, Co-founder,
Chairman, CEO, and President of ZyVersa. “We have progressed
manufacturing of IC 100 through GMP production, and our
IND-enabling preclinical program has progressed through
demonstration of IC 100 safety in dose-ranging toxicology studies
in mice and monkeys.”
Mr. Glover continued, “We expect to complete the preclinical
program for IC 100 by year’s end, and file an IND to initiate a
Phase 1 trial in early 2024. We are excited about our progress, as
we believe Inflammasome ASC Inhibitor IC 100 has potential to
transform treatment of debilitating inflammatory diseases.”
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, and 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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