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 acclaimed 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, Angiogenesis. The paper demonstrates the
crucial role of inflammasome ASC and ASC specks in the development
of oxygen-induced retinopathy and provides data showing that
Inflammasome ASC Inhibitor IC 100 attenuates impairment of retinal
structure and function.
The paper titled, “IC 100, a humanized therapeutic monoclonal
anti-ASC antibody alleviates oxygen-induced retinopathy in mice,”
summarizes research evaluating mouse models representative of ROP.
Following is a summary of key findings:
- ASC specks, which lead to
inflammasome activation, were significantly increased in animal
model retinas and colocalized with the abnormal vasculature, along
with increased microglial activation indicative of retinal
inflammation that leads to retinal damage and disease
progression.
- IC 100 decreased expression of
inflammasome-related molecules (ASC, gasdermin D), inflammatory
cytokines (IL-1β, IL-6, and TNF), and VEGF in animal model
retinas.
- Importantly, IC 100 reduced ASC
speck formation and microglial activation, attenuating
inflammation, abnormal vascularization, retinal thinning, and
retinal dysfunction.
- The structural and functional
improvements demonstrated with IC 100 treatment correlated with
corrections of hyperoxia-modulated gene pathways associated with
eye development, leukocyte migration, angiogenesis, inflammation,
neurogenesis, and VEGF signaling.
“We have demonstrated that IC 100 effectively treated both
phases of oxygen-induced retinopathy in a mouse model that
resembles ROP in preterm infants, as it decreased retinal
vaso-obliteration and intravitreal vascularization,” said Dr. Shu
Wu, Professor of Pediatrics at the University of Miami. “Our data
suggest that IC 100 may have potential therapeutic use in the
treatment of preterm infants with ROP.”
“This research highlighting that Inflammasome ASC Inhibitor IC
100 attenuated retinal inflammation, abnormal retinal
vascularization, and retinal thinning leading to restored retinal
function in an animal model of ROP supports the broad range of
indications that IC 100 has potential to treat. ROP is the sixth
indication with preclinical data demonstrating that IC 100
attenuates pathogenic inflammasome signaling pathways resulting in
reduced inflammation and improved histopathological and/or
functional outcomes,” stated Stephen C. Glover, ZyVersa’s
Co-founder, Chairman, CEO, and President. “The other promising
indications are early Alzheimer’s disease, multiple sclerosis,
acute respiratory distress syndrome, spinal cord injury, and
traumatic brain injury.”
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, 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 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.
The lead indication for IC 100 is obesity and its associated
metabolic complications. To review a white paper summarizing the
mechanism of action and preclinical data for IC 100, Click
Here.
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
inflammatory or kidney diseases with high unmet medical needs. We
are well positioned in the rapidly emerging inflammasome space with
a highly differentiated monoclonal antibody, Inflammasome ASC
Inhibitor IC 100, and in kidney disease with phase 2 Cholesterol
Efflux Mediator™ VAR 200. The lead indication for IC 100 is
obesity and its associated metabolic complications, and for VAR
200, focal segmental glomerulosclerosis (FSGS). Each therapeutic
area offers a “pipeline within a product,” with potential for
numerous indications. The total accessible market is over $100
billion. 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, Media, and IR Contact:Karen
CashmereChief Commercial
Officerkcashmere@zyversa.com786-251-9641
ZyVersa Therapeutics (NASDAQ:ZVSA)
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