ProKidney LP (“ProKidney”), a leading clinical-stage cellular
therapeutics company focused on chronic kidney disease (“CKD”),
today announced the publication of the trial design of its Phase II
clinical study of its novel Renal Autologous Cell Therapy (REACT®)
in the American Journal of Nephrology. The paper, titled
Novel Renal Autologous Cell Therapy for Type 2 Diabetes
Mellitus Chronic Diabetic Kidney Disease: Clinical Trial
Design, was published online and will appear in a future
print edition of the Journal (DOI: 10.1159/000520231).
“Renal autologous cell therapy, or REACT®, is a
potentially groundbreaking treatment for CKD patients, a population
in dire need of new, more effective therapeutic options,” said
Joseph Stavas, M.D., ProKidney’s SVP Clinical Development and lead
author of the manuscript. “Publication of the study design in a
prestigious peer-reviewed journal highlights the importance of the
trial and the implications for advancing care in this patient
population. We have generated compelling interim data from the
study and look forward to submitting the final results for
presentation at a future medical meeting.”
The study is a prospective, multicenter,
randomized control, open-label Phase II clinical trial that
enrolled a total of 83 subjects ages 30-80 with Type 2 diabetic
kidney disease. Following a kidney biopsy, subjects were randomized
1:1 to receive either active treatment with REACT® or optimized
standard of care. Patients in the REACT® cohort receive two
injections to be given six months apart in the same kidney that was
biopsied. Subjects in the standard of care treatment arm receive
optimal lifestyle and contemporaneous pharmacologic management of
their disease (including SGLT2s, GLP-1, finerenone) for 12 months
before crossing over to receive REACT® treatment. The primary
safety endpoint is assessment of procedure- and REACT®-related
adverse events through 24 months after the last REACT® dose. The
primary efficacy endpoint is a measurement of estimated glomerular
filtration rate (eGFR) from baseline through 24 months after the
last REACT® dose. Additional information can be found at
http://clinicaltrials.gov/ct2/show/NCT02836574.
About REACT®
REACT® has the potential to not only slow the
progression of CKD, but in some cases drive meaningful improvement
in kidney function – a groundbreaking first in CKD therapies.
A cell therapy product produced from a patient’s
own kidney cells, REACT® comprises a proprietary mixture of
progenitor cells that have been grown and selected, so they can be
placed back into the patient’s kidney. This minimally invasive
procedure, starting with a standard biopsy, provides the cells that
harness the body’s intrinsic ability to repair and restore damaged
kidney tissue. The outpatient reinjection procedure has been shown
to be safer than contemporary biopsy and renal failure treatment
options, such as dialysis and organ transplant.
About ProKidney
ProKidney, a pioneer in the treatment of chronic
kidney disease (CKD) through innovations in cellular therapy, was
founded in 2015 after a decade of research. ProKidney’s lead
product candidate, REACT® (Renal Autologous Cell Therapy), is a
first-of-its-kind, patented disease-modifying autologous cellular
therapy with the potential to not only slow and stabilize the
progression of CKD, but in some cases drive meaningful improvement
in kidney function. REACT® has received Regenerative Medicine
Advanced Therapy (RMAT) designation, as well as FDA and EMA
guidance, supporting an immediate start to its Phase 3 clinical
program, which launched on schedule in January 2022. On January 18,
2022, ProKidney announced that it would become a publicly traded
company via a business combination with Social Capital Suvretta
Holdings Corp. III (Nasdaq: DNAC). For more information, visit
www.prokidney.com.
Additional Information and Where to Find
It
In connection with the proposed transaction,
Social Capital Suvretta Holdings Corp. III (“SCS”) intends to file
a preliminary proxy statement and a definitive proxy statement with
the U.S. Securities and Exchange Commission (the “SEC”).
SHAREHOLDERS OF SCS ARE ADVISED TO READ, WHEN AVAILABLE, THE
PRELIMINARY PROXY STATEMENT, ANY AMENDMENTS THERETO, THE DEFINITIVE
PROXY STATEMENT AND ALL OTHER RELEVANT DOCUMENTS FILED OR THAT WILL
BE FILED WITH THE SEC IN CONNECTION WITH THE PROPOSED TRANSACTION
AS THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT
INFORMATION. HOWEVER, THIS DOCUMENT WILL NOT CONTAIN ALL THE
INFORMATION THAT SHOULD BE CONSIDERED CONCERNING THE PROPOSED
TRANSACTION. IT IS ALSO NOT INTENDED TO FORM THE BASIS OF ANY
INVESTMENT DECISION OR ANY OTHER DECISION IN RESPECT OF THE
PROPOSED TRANSACTION. When available, the definitive proxy
statement will be mailed to the shareholders of SCS as of a record
date to be established for voting on the proposed transaction.
Shareholders will also be able to obtain copies of the preliminary
proxy statement, the definitive proxy statement and other documents
filed with the SEC that will be incorporated by reference therein,
without charge, once available, at the SEC’s website at
http://www.sec.gov.
The documents filed by SCS with the SEC also may
be obtained free of charge at SCS’s website at
https://socialcapitalsuvrettaholdings.com/dnac or upon written
request to 2850 W. Horizon Ridge Parkway, Suite 200, Henderson, NV
89052.
Participants in the
Solicitation
SCS and ProKidney, LP and their respective
directors and executive officers may be deemed to be participants
in the solicitation of proxies from SCS’s shareholders in
connection with the proposed transaction. A list of the names of
such directors and executive officers and information regarding
their interests in the proposed transaction between ProKidney and
SCS will be contained in the proxy statement when available. You
may obtain free copies of these documents as described in the
preceding paragraph.
No Offer or Solicitation
This communication shall not constitute a
solicitation of a proxy, consent or authorization with respect to
any securities or in respect of the proposed transaction. This
communication 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 states or jurisdictions in which such
offer, solicitation or sale would be unlawful prior to registration
or qualification under the securities laws of such state or
jurisdiction. No offering of securities shall be made except by
means of a prospectus meeting the requirements of Section 10 of the
Securities Act of 1933, as amended or an exemption therefrom.
Forward-Looking Statements
This communication may contain certain
forward-looking statements within the meaning of the federal
securities laws with respect to the proposed transaction between
ProKidney and SCS. 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.
Forward-looking statements are predictions, projections and other
statements about future events that are based on current
expectations and assumptions and, as a result, are subject to risks
and uncertainties. Many factors could cause actual future events to
differ materially from the forward-looking statements in this
communication, including but not limited to: (i) the risk that the
proposed transaction may not be completed in a timely manner or at
all, which may adversely affect the price of SCS’s securities, (ii)
the risk that the proposed transaction may not be completed by
SCS’s business combination deadline and the potential failure to
obtain an extension of the business combination deadline if sought
by SCS, (iii) the failure to satisfy the conditions to the
consummation of the proposed transaction, including the adoption of
the definitive agreement related to the business combination
between SCS and ProKidney (the “Business Combination Agreement”) by
the shareholders of SCS and the satisfaction of the minimum cash
condition, (iv) the lack of a third party valuation in determining
whether or not to pursue the proposed transaction, (v) the
inability to complete the private placement entered into in
connection with the transaction, (vi) the occurrence of any event,
change or other circumstance that could give rise to the
termination of the Business Combination Agreement, (vii) the effect
of the announcement or pendency of the transaction on ProKidney’s
business relationships, operating results, and business generally,
(viii) risks that the proposed transaction disrupts current plans
and operations of ProKidney and potential difficulties in ProKidney
employee retention as a result of the transaction, (ix) the outcome
of any legal proceedings that may be instituted against ProKidney
or against SCS related to the Business Combination Agreement or the
proposed transaction, (x) the ability to maintain the listing of
SCS’s securities on a national securities exchange, (xi) the price
of SCS’s securities may be volatile due to a variety of factors,
including changes in the competitive and highly regulated
industries in which SCS plans to operate or ProKidney operates,
variations in operating performance across competitors, changes in
laws and regulations affecting SCS’s or ProKidney’s business, and
changes in the combined capital structure, (xii) the ability to
implement business plans, forecasts, and other expectations after
the completion of the proposed transaction, and identify and
realize additional opportunities and (xiii) the risk of downturns
and a changing regulatory landscape in the highly competitive
biotechnology industry. The foregoing list of factors is not
exhaustive. You should carefully consider the foregoing factors and
the other risks and uncertainties described in the “Risk Factors”
section of SCS’s registration on Form S-1 (File No. 333-256725),
SCS’s quarterly report on Form 10-Q for the quarter ended September
30, 2021 filed with the SEC on November 15, 2021, the final proxy
statement of SCS, when available, including those under “Risk
Factors” therein and other documents filed by SCS from time to time
with the SEC. These filings identify and address other important
risks and uncertainties that could cause actual events and results
to differ materially from those contained in the forward-looking
statements. 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 ProKidney and SCS 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 ProKidney nor SCS gives any
assurance that either ProKidney or SCS, or the combined company,
will achieve its expectations.
Contacts:
Investors:Lee RothBurns
McClellanlroth@burnsmc.com+1 (212) 300-8331
Media: Robert Flamm, Ph.D.Burns
McClellanrlfamm@burnsmc.com
Social Capital Suvretta ... (NASDAQ:DNAC)
Graphique Historique de l'Action
De Août 2024 à Sept 2024
Social Capital Suvretta ... (NASDAQ:DNAC)
Graphique Historique de l'Action
De Sept 2023 à Sept 2024