Tricida Provides Update on Timing of Top-Line Data for the VALOR-CKD Trial Based on Conflict in Ukraine
02 Março 2022 - 6:26PM
Tricida, Inc. (Nasdaq: TCDA), a pharmaceutical company focused
on the development and commercialization of its investigational
drug candidate, veverimer, a non-absorbed, orally-administered
polymer designed to slow chronic kidney disease (CKD) progression
in patients with metabolic acidosis and CKD, announced today an
update on the anticipated date for top-line data from the VALOR-CKD
trial based on the ongoing events in Ukraine. Approximately fifteen
percent (15%) of the patients randomized in VALOR-CKD are from
Ukraine. Given the uncertainty around future participation of
Ukrainian subjects in the trial and the potential challenges to
collecting and monitoring data from Ukrainian sites, top-line data
from the VALOR-CKD trial is now anticipated early in the fourth
quarter of 2022, versus Tricida’s previous guidance of the third
quarter of 2022. The revised guidance is based on Tricida’s
evaluation of the current situation in Ukraine which is dynamic.
Its estimates may change as events in Ukraine evolve. Tricida
believes it will need this incremental time to deal with
anticipated disruptions and/or delays in data collection. Tricida
does not expect the utility of the data already collected from
Ukrainian subjects to be affected. Based upon the latest review of
its forecast, Tricida believes that its financial resources
will extend for approximately six months following the anticipated
announcement of top-line results from the VALOR-CKD trial.
As of March 1, 2022, the VALOR-CKD trial had accrued 197
subjects with positively adjudicated primary endpoint events,
defined as renal death, end-stage renal disease (ESRD), or greater
than or equal to a 40% decline in estimated glomerular filtration
rate (eGFR), with an average treatment duration of approximately 23
months.
“We are deeply concerned for the people of Ukraine, including
the VALOR-CKD patients, investigators, site staff and our CRO
colleagues who we have worked with for many years. We are horrified
by what they and all of the Ukrainian people are having to endure
defending their homeland against a brutal Russian invasion,” said
Gerrit Klaerner, Ph.D., Tricida’s Chief Executive Officer and
President. “We believe that an incremental delay of the
administrative stop is prudent to obtain interpretable data from
the VALOR-CKD trial with approximately the same number of events
and six-months cash runway as outlined in our prior
communications.”
About Tricida
Tricida, Inc. is a pharmaceutical company focused on the
development and commercialization of its investigational drug
candidate, veverimer, a non-absorbed, orally-administered polymer
designed to slow CKD progression in patients with metabolic
acidosis and CKD. Tricida is currently conducting a renal outcomes
clinical trial, VALOR-CKD, to determine if veverimer slows CKD
progression in patients with metabolic acidosis associated with
CKD. Metabolic acidosis is a condition commonly caused by CKD that
is believed to accelerate the progression of kidney deterioration.
There are currently no therapies approved by the FDA to slow
progression of kidney disease through the treatment of chronic
metabolic acidosis in patients with CKD. It is estimated to pose a
health risk to approximately three million patients with CKD in the
United States.
For more information about Tricida, please
visit Tricida.com.
Cautionary Note on Forward-Looking
Statements
This press release includes forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. Forward-looking
statements relate to expectations concerning matters that are not
historical facts. Words such as “projects,” “believes,”
“anticipates,” “plans,” “expects,” “intends,” “may,” “will,”
“could,” “should,” “would,” and similar words and expressions are
intended to identify forward-looking statements. These
forward-looking statements include, but are not limited to,
statements regarding the Company’s plans and expectations for the
VALOR-CKD trial, including early termination of the trial, and the
rate of accrual of primary endpoint events, and its expectations
regarding the potential timing of the announcement of top-line date
from the VALOR-CKD trial and its financial runway. These
forward-looking statements involve risks and uncertainties that
could cause actual results to differ materially from those
discussed in such forward-looking statements. Such risks and
uncertainties include, without limitation, developments in Ukraine
and the region, the Company’s plans and expectations for its
VALOR-CKD trial, including the estimated number of subjects with
primary endpoints in the final analysis and the estimated timing
for receipt of top-line data from that trial, and risks associated
with the Company’s business prospects, financial results and
business operations.
These and other factors that may affect the Company’s future
business prospects, results and operations are identified and
described in more detail in the Company’s filings with the
Securities and Exchange Commission (the “SEC”), including the
Company’s most recent Annual Report filed on Form 10-K and the
subsequently filed Quarterly Report(s) on Form 10-Q. You should not
place undue reliance on these forward-looking statements, which
speak only as of the date of this press release. Except as required
by applicable law, the Company does not intend to update any of the
forward-looking statements to conform these statements to actual
results, later events or circumstances or to reflect the occurrence
of unanticipated events.
Contact:Jackie Cossmon, IRCTricida, Inc.Senior Vice President of
Investor Relations and CommunicationsIR@Tricida.com
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