IC 100, a novel monoclonal antibody inflammasome ASC
inhibitor, targets multiple types of inflammasomes to block
initiation and perpetuation of damaging chronic
inflammation
IC 100 has broad tissue distribution, including CNS and
peripheral tissues, is rapidly internalized by a variety of
cell types, binds to intracellular ASC blocking inflammasome
activation, and binds to ASC specks altering ASC speck architecture
and function
WESTON,
Fla. and BRIDGEWATER,
N.J., Aug. 3, 2022 /PRNewswire/ -- ZyVersa
Therapeutics, Inc., (ZyVersa) a clinical stage specialty
biopharmaceutical company developing first-in-class drugs for
treatment of inflammatory and renal diseases, and Larkspur Health
Acquisition Corp. (NASDAQ: LSPR or "Larkspur"), a blank-check
special purpose acquisition company are pleased to announce that
Translational Research has published data highlighting the
differentiated mechanism of action of ZyVersa's Inflammasome ASC
Inhibitor, IC 100. This research was conducted by renowned
scientists from the University of Miami
Miller School of Medicine, Drs. Robert W.
Keane and Juan Pablo de Rivero
Vaccari.
By inhibiting ASC, ZyVersa's IC 100 has
potential to broadly downregulate inflammation to treat a multitude
of diseases.
"Inflammasome dysregulation underlies the pathophysiology of
many inflammatory conditions and diseases," stated Dr. Robert W. Keane, Professor, Physiology and
Biophysics, Neurological Surgery and Microbiology, and Immunology,
University of Miami Miller School of
Medicine. "We developed a mAb, IC 100, to specifically inhibit
inflammasome ASC, which is central to formation and activation of
different inflammasome complexes. Upon inflammasome formation, ASC
oligomerizes to form a signaling platform, the ASC speck, which
activates IL-1β to initiate an inflammatory cascade. ASC
specks are released from cells by pyroptosis, where they accumulate
in inflamed tissues or are internalized by neighboring cells
thereby perpetuating the inflammatory response."
Dr. Keane continued, "Our data published in Translational
Research demonstrate that IC 100 gains access into cells and
binds to ASC, and also alters the structure of ASC specks,
inhibiting activation and release of IL-1 β to attenuate this
process. We believe that based on this unique mechanism of action,
IC 100 has potential to broadly downregulate inflammation
independent of the ligands and sensors involved and effectively
treat the heightened inflammatory response contributing to a
multitude of diseases and conditions."
"We are especially excited about the diverse range of
inflammatory diseases that IC 100 has potential to treat",
indicated Dr, Juan Pablo de Rivero
Vaccari, Associate Professor, Department of Neurological
Surgery and The Miami Project to Cure Paralysis, and Distinguished
Faculty Member of the Center for Cognitive Neuroscience and Aging
at the University of Miami Miller
School of Medicine. "Our newly published data reveal that IC 100
penetrates both the CNS (brain and spinal cord) and peripheral
tissues (heart, lungs, kidneys, and liver). Likewise, our previous
work has demonstrated the therapeutic potential of inhibiting ASC
in animal models representing a variety of diseases, including
multiple sclerosis, acute respiratory distress syndrome, traumatic
brain injury, spinal cord injury, and age-related inflammation
associated with conditions such as Alzheimer's disease."
To review the publication, Click Here .
About 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, 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 is a clinical stage specialty biopharmaceutical company
leveraging advanced, proprietary technologies to develop
first-in-class drugs. Our focus is on patients with inflammatory or
renal diseases who have significant unmet medical needs. Our
development pipeline includes a novel inflammasome ASC inhibitor
with potential to treat multiple CNS and other inflammatory
diseases. It also includes phase 2a-ready VAR 200, a cholesterol
efflux mediator for treatment of rare kidney disease, focal
segmental glomerulosclerosis (FSGS). VAR 200 has potential to treat
other kidney diseases, such as Alport Syndrome and Diabetic Kidney
Disease. For more information, please visit www.zyversa.com.
About Larkspur Health Acquisition
Corp.
Larkspur is a Special Purpose Acquisition Company (SPAC) formed
to identify a biopharmaceutical company that can develop and thrive
as a newly formed public company and benefit from Larkspur's
operational expertise and a significant infusion of capital. Each
of Larkspur's management team and board of directors have been
former management and executive leadership of private and public
biopharmaceutical companies and have over 50+ years of aggregate
investment and operational experiences. The team strongly believes
in the growth opportunities in the biotechnology industry. They are
experienced operators who seek to partner with top innovators and
thinkers in the biopharmaceutical field. As operators, their
entrepreneurial approach enables support for management teams in
making impactful decisions with an eye toward growth and
operational excellence. For more information, please visit
www.lsprhealth.com.
Forward Looking
Statements
This press release contains certain forward-looking statements
within the meaning of the federal securities laws with respect to
certain product candidates that will be the subject of a proposed
transaction between Larkspur Health Acquisition Corp. ("Larkspur"),
and ZyVersa Therapeutics, Inc ("ZyVersa"). All statements other
than statements of historical facts contained in this press
release, including statements regarding Larkspur or ZyVersa's
future results of operations and financial position, the amount of
cash expected to be available to ZyVersa after the closing and
giving effect to any redemptions by Larkspur's stockholders,
ZyVersa's business strategy, prospective product candidates,
product approvals, research and development costs, timing and
likelihood of success, plans and objectives of management for
future operations, future results of current and anticipated
product candidates, and expected use of proceeds, are
forward-looking statements. These forward-looking statements
generally are identified by the words "believe," "project,"
"expect," "anticipate," "estimate," "intend," "strategy," "future,"
"opportunity," "plan," "may," "should," "will," "would," "will be,"
"will continue," "will likely result," and similar expressions.
These forward-looking statements are subject to a number of risks,
uncertainties and assumptions, including, but not limited to, the
following risks relating to the proposed transaction: the
occurrence of any event, change or other circumstances that could
give rise to the termination of the Business Combination Agreement;
the risk that the transaction may not be completed in a timely
manner or at all, which may adversely affect the price of
Larkspur's securities; the occurrence of any event, change or other
circumstances that could give rise to the termination of the Merger
Agreement; the inability to complete the Transactions, including
due to failure to obtain approval of the shareholders of Larkspur
or other conditions to closing in the Merger Agreement; the
inability to obtain or maintain the listing of Larkspur's common
stock on NASDAQ following the Transactions; the risk that the
Transactions disrupt current plans and operations of ZyVersa as a
result of the announcement and consummation of the Transactions;
the ability to recognize the anticipated benefits of the
Transactions, which may be affected by, among other things,
competition, the ability of the combined company to grow and manage
growth economically and hire and retain key employees; the risks
that ZyVersa's product candidates in development fail clinical
trials or are not approved by the U.S. Food and Drug Administration
or other applicable authorities; costs related to the Transactions;
changes in applicable laws or regulations; the possibility that
Larkspur or ZyVersa may be adversely affected by other economic,
business, and/or competitive factors; and other risks and
uncertainties to be identified in the proxy statement/prospectus
(when available) relating to the Transactions, including those
under "Risk Factors" therein, and in other filings with the SEC
made by Larkspur.. Moreover, ZyVersa operates in a very competitive
and rapidly changing environment. Because forward-looking
statements are inherently subject to risks and uncertainties, some
of which cannot be predicted or quantified and some of which are
beyond Larkspur's and ZyVersa's control, you should not rely on
these forward-looking statements as predictions of future events.
Forward-looking statements speak only as of the date they are made.
Readers are cautioned not to put undue reliance on forward-looking
statements, and except as required by law. Larkspur and ZyVersa
assume no obligation and do not intend to update or revise these
forward-looking statements, whether as a result of new information,
future events, or otherwise. Neither Larkspur nor ZyVersa gives any
assurance that either Larkspur or ZyVersa or the combined company
will achieve its expectations.
Important Information for
Investors and Stockholders and Where to Find It
Larkspur intends to file a registration statement on Form S-4
that will include a proxy statement with respect to the stockholder
meeting of Larkspur and a prospectus with respect to securities of
the combined company. After the registration statement is declared
effective by the SEC, the proxy statement/prospectus will be sent
to all Larkspur and ZyVersa stockholders. Larkspur will also file
other documents regarding the proposed business combination with
the SEC. BEFORE MAKING ANY VOTING DECISION, INVESTORS AND
SECURITIES HOLDERS OF LARKSPUR AND ZYVERSA ARE URGED TO READ THE
PROXY STATEMENT/PROSPECTUS AND ALL OTHER RELEVANT DOCUMENTS FILED
OR THAT WILL BE FILED WITH THE SEC IN CONNECTION WITH THE PROPOSED
BUSINESS COMBINATION AS THEY BECOME AVAILABLE SINCE THEY WILL
CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED BUSINESS
COMBINATION AND THE PARTIES TO THE PROPOSED BUSINESS
COMBINATION.
Investors and securities holders will be able to obtain free
copies of the proxy statement/prospectus and all other relevant
documents filed or that will be filed with the SEC by Larkspur
through the website maintained by the SEC at https://sec.gov/. In
addition, the documents filed by Larkspur may be obtained free of
charge from Larkspur's website at www.lsprhealth.com or by written
request to info@lsprhealth.com
Participants in the
Solicitation
Larkspur, ZyVersa, and their respective directors and executive
officers may be deemed to be participants in the solicitation of
proxies from Larkspur's stockholders in connection with the
proposed transaction. Information about Larkspur's directors and
executive officers and their ownership of Larkspur's securities is
set forth in Larkspur's Annual Report on Form 10-K for the year
ended December 31, 2021, filed with
the SEC, as modified or supplemented by any Form 3 or Form 4 filed
with the SEC since the date of such filing. Other information
regarding the interests of the participants in the proxy
solicitation will be included in the proxy statement/prospectus
pertaining to the proposed Transactions when it becomes
available.
No Offer or Solicitation
This release shall not constitute an offer to sell or the
solicitation of an offer to buy any securities, nor shall there be
any sale of securities in any state or jurisdiction in which such
offer, solicitation or sale would be unlawful prior to registration
or qualification under the securities laws of any such state or
jurisdiction. No offer of securities shall be made except by means
of a prospectus.
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SOURCE ZyVersa Therapeutics, Inc.; Larkspur Health Acquisition
Corp.