ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical
stage specialty biopharmaceutical company developing first-in-class
drugs for treatment of renal and inflammatory diseases, announces
publication of a paper in the peer-reviewed journal, Nature Reviews
Nephrology, that summarizes data highlighting how lipid
accumulation in the kidneys contributes to CKD development and
disease progression.
In the review paper titled, “Kidney lipid dysmetabolism and
lipid droplet accumulation in chronic kidney disease,” the
following key points were made:
- Lipids and lipid-related enzymes have a major role in
modulating the function of the kidney’s filtration system, and
lipid accumulation can drive CKD irrespective of circulating lipid
levels and use of systemic lipid lowering drugs like statins.
- Although several lipid types, including cholesterol,
triglycerides, fatty acids, and phospholipids, are dysregulated in
the kidney and contribute to CKD progression, dysregulation of
cholesterol metabolism is one of the hallmarks of kidney injury in
CKD. Cholesterol accumulation occurs in association with impaired
transport of cholesterol out of the kidney.
- Accumulation of fatty acids triggers kidney cell damage by
promoting inflammation and fibrosis.
The paper includes a brief overview of Cholesterol Efflux
Mediator™ VAR 200 (hydroxy-propyl-beta-cyclodextrin),
highlighting that it reduced cholesterol accumulation and cell
death (apoptosis) in podocytes in vitro, and provided protection
from kidney disease progression in mouse models of diabetic kidney
disease, FSGS, and Alport Syndrome. The authors concluded this
section by stating that VAR 200, which is in development for
patients affected by several forms of kidney disease, provides
therapeutic potential for diseases characterized by ABCA1
deficiency. To read the article, Click Here.
“The numerous studies summarized in the paper published in
Nature Reviews Nephrology reinforce the importance of addressing
kidney accumulation of cholesterol and lipids to help attenuate
progression of chronic kidney disease, which affects over 35
million adults in the United States,” commented Stephen C. Glover,
ZyVersa’s Co-founder, Chairman, CEO, and President. “Currently,
over 130,000 patients with kidney disease progress to renal failure
each year, and more than 800,000 patients are living with renal
failure requiring dialysis or transplant to sustain life. We are
hopeful that protection against kidney injury, fibrosis, and
disease progression seen with VAR 200 in animal models of diabetic
kidney disease, FSGS, and Alport Syndrome will translate to humans.
Our first clinical trial with VAR 200 in patients with diabetic
kidney disease is planned to begin in early 2024.” To review a
white paper summarizing the preclinical research with VAR 200,
Click Here.
About Cholesterol Efflux
Mediator™ VAR 200
Cholesterol Efflux Mediator™ VAR 200
(2-hydroxypropyl-beta-cyclodextrin, 2HPβCD) is a phase 2a-ready
drug in development to ameliorate renal lipid accumulation that
damages the kidneys’ filtration system, leading to kidney disease
progression. VAR 200 passively and actively removes excess lipids
from the kidney.
Preclinical studies with VAR 200 in animal models of FSGS,
Alport syndrome, and diabetic kidney disease demonstrate that
removal of excess cholesterol and lipids from kidney podocytes
protects against structural damage and reduces excretion of protein
in the urine (proteinuria).
The lead indication for VAR 200 is orphan kidney disease focal
segmental glomerulosclerosis (FSGS). VAR 200 has potential to treat
other glomerular diseases, including orphan Alport syndrome and
diabetic kidney disease.
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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