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
publication of an article in the peer-reviewed Biomedical Journal
demonstrating that inhibiting NLRP3 inflammasomes in an IBD animal
model attenuates intestinal inflammation and tissue damage, leading
to significant improvements in IBD symptoms, and restoration of
normal intestinal microbial flora.
In the paper titled, “Inhibition of NLRP3 attenuates sodium
dextran sulfate-induced inflammatory bowel disease through gut
microbiota regulation,” the authors evaluated human colon biopsy
samples from patients with IBD and healthy controls, and conducted
a study in an IBD mouse model. Following are key findings reported
in the paper:
- NLRP3 and IL-1β expression is
increased in the colon of IBD patients.
- NLRP3 inhibition in the IBD animal
model:
- Inhibited NLRP3 inflammasome
signaling in the colon, resulting in significantly reduced levels
of the pro-inflammatory cytokines IL-1b, IL-6, and TNF-α.
- Alleviated severe diarrhea and
significantly improved IBD symptoms, based on the disease activity
index score.
- Attenuated histopathological changes
indicative of tissue damage (goblet cell reduction, crypt
destruction, and epithelial barrier disruption).
- Restored gut microbiota to
normal.
The authors stated, “In conclusion, this study provides direct
evidence that NLRP3 signaling is over-activated in IBD patients.
The inhibition of NLRP3 reverses the IBD-like symptoms in
DSS-induced mice, which the regulatory effects on gut microbiota
might mediate. Overall, this present study provides a basis for the
clinical application of NLRP3 as a target for IBD treatment.” To
read the article, Click Here.
“Restoration of quality of life is the ultimate long-term goal
in IBD management. Although disease remission can often be achieved
with current therapies, bothersome symptoms can still prevail,”
stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO and
President. “The research published in the Biomedical Journal
provides support for inflammasome inhibition as a promising
treatment option for IBD. ZyVersa is developing Inflammasome ASC
inhibitor IC 100. Unlike NLRP3 inhibitors, designed to inhibit
formation of one inflammasome to block initiation of the
inflammatory cascade, IC 100 was designed to inhibit multiple types
of inflammasomes and their associated ASC specks to uniquely block
both initiation and perpetuation of damaging inflammation, which we
believe is necessary to control chronic 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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