ZyVersa Therapeutics Engages CRO, George Clinical, for Phase 2a Clinical Trial for Cholesterol Efflux Mediator VAR 200
December 14 2023 - 6:01AM
ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA; “ZyVersa”), a clinical
stage specialty biopharmaceutical company developing first-in-class
drugs for treatment of patients with renal and inflammatory
diseases who have unmet medical needs, announces selection of
contract research organization (“CRO”) George Clinical to manage
its Phase 2a clinical trial with Cholesterol Efflux MediatorTM VAR
200 in patients with diabetic kidney disease (DKD). The clinical
trial is expected to begin in the first quarter of 2024.
George Clinical is a leading global CRO, headquartered in
Sydney, Australia, with more than 500 experienced people in 39
locations providing the full range of clinical trial services to
pharmaceutical, medical device, and diagnostic customers for all
trial phases, registration, and post-marketing trials. George
Clinical, who combines scientific and clinical leadership with
expert trial delivery to create distinctive world-class solutions,
was the recipient of Citeline’s 2023 Clinical Research Team of the
Year. They were recognized for their success in achieving their
goals, effective work practices, creative solutions, and meeting
major milestones within expected timelines.
“Initiation of the Phase 2a trial in patients with DKD marks a
major milestone in the development of Cholesterol Efflux MediatorTM
VAR 200 and for ZyVersa. It is the first clinical trial for VAR 200
and will help establish its effectiveness and safety in renal
patients, and it will provide valuable insights to guide
development for other planned renal indications (focal segmental
glomerulosclerosis and Alport syndrome),” said Stephen C. Glover,
ZyVersa’s Co-founder, Chief Executive Officer, and Chairman. “We
are pleased to partner with George Clinical to manage this
important study. With their unparalleled renal research experience
in more than 50 chronic renal disease trials and their reputation
as a high performing renal CRO, we are confident that our trial
will be conducted in an efficient and timely manner to achieve our
milestones and advance VAR 200’s development program to the next
level.”
“Collaborating with ZyVersa Therapeutics on this trial shows not
only our passion for kidney research but also the commitment to
provide the necessary clinical research around innovative
treatments that could help patients with unmet medical needs,” said
George Clinical Chief Medical Officer Maria Ali.
About VAR 200
Cholesterol Efflux MediatorTM 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
and its progression. VAR 200 passively and actively removes excess
lipids from the kidney.
Preclinical studies in animal models of diabetic kidney disease,
FSGS, and Alport syndrome, demonstrate that removal of excess
cholesterol and lipids from the kidney’s filtration system with VAR
200 protects against structural damage and reduces excretion of
protein in the urine (proteinuria). VAR 200 has potential to treat
multiple kidney diseases, including diabetic kidney disease, and
rare kidney diseases, FSGS (focal segmental glomerulosclerosis) and
Alport syndrome. For more information about VAR 200, Click
Here.
About ZyVersa Therapeutics, Inc.
ZyVersa is a clinical stage specialty biopharmaceutical company
leveraging advanced, proprietary technologies to develop
first-in-class drugs. Our focus is on patients with renal or
inflammatory diseases who have significant unmet medical needs. Our
development pipeline includes phase clinical stage Cholesterol
Efflux MediatorTM VAR 200 in development to alleviate damaging
accumulation of cholesterol and lipids in the filtering system of
the kidneys. The lead indication is treatment of rare kidney
disease, focal segmental glomerulosclerosis. VAR 200 has potential
to treat other kidney diseases, including Alport syndrome and
diabetic kidney disease. ZyVersa’s pipeline also includes
proprietary inflammasome ASC inhibitor IC 100 that blocks
initiation and perpetuation of damaging inflammation associated
with a multitude of inflammatory diseases. IC 100 has potential to
treat many different 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. A
discussion of these and other factors, including risks and
uncertainties with respect to ZyVersa, is set forth in ZyVersa’s
filings with the Securities and Exchange Commission, including
ZyVersa’s Annual Report on Form 10-K and its Quarterly Reports on
Form 10-Q.
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.
Corporate and IR ContactKaren CashmereChief
Commercial
Officerkcashmere@zyversa.com786-251-9641
Media ContactsCasey
McDonaldcmcdonald@tiberend.com646-577-8520
Dave SchemeliaDschemelia@tiberend.com609-468-9325
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