Tricida Announces Multiple Data Presentations on Veverimer & Metabolic Acidosis to Be Given at the Virtual National Kidney Fo...
March 24 2020 - 8:30AM
Business Wire
Tricida, Inc. (Nasdaq: TCDA), a pharmaceutical company focused
on the development and commercialization of its drug candidate,
veverimer (TRC101), a non-absorbed, orally-administered polymer
designed to treat metabolic acidosis in patients with chronic
kidney disease (CKD), announced today that multiple presentations
on Tricida’s lead asset, veverimer, will be given at the National
Kidney Foundation 2020 Spring Clinical Meetings taking place from
March 25 - 29, 2020.
Tricida-sponsored presentations will include clinical trial
data from the company’s veverimer clinical trials and the ULTIMA
CKD Registry:
Title:
Effects of Veverimer on Serum Bicarbonate
and Physical Function in Patients with Congestive Heart Failure and
Chronic Kidney Disease: Subgroup Analysis from a Randomized
Trial
Author:
D. Wesson et al.
Link:
View poster here
Poster #:
204
Title:
CKD as a Model of Accelerated Aging and
Improvement in Physical Function with Investigational Product
Veverimer
Author:
M. Abramowitz et al.
Link:
View poster here
Poster #:
219
Title:
Understanding the Long-Term Impact of
Metabolic Acidosis in CKD: Design of the ULTIMA-CKD Registry.
Author:
V. Mathur et al.
Link:
View poster here
Poster #:
291
Title:
Mechanism of Action and Onset of Effect of
Veverimer, A Novel Acid Binder for the Treatment of Metabolic
Acidosis Associated with Chronic Kidney Disease (CKD)
Author:
D. Bushinsky et al.
Link:
View poster here
Poster #:
314
Title:
Effects of Veverimer on Serum Bicarbonate
and Physical Function in Patients with Diabetes and Chronic Kidney
Disease: Subgroup Analysis from a Randomized Trial
Author:
D. Wesson et al.
Link:
View poster here
Poster #:
335
Data from other Tricida-sponsored studies on the impact of
metabolic acidosis on CKD progression and physical function will
also be presented:
Title:
Metabolic Acidosis is a Predictive Factor
for All-Cause Mortality in Patients with Chronic Kidney Disease
Author:
N. Tangri et al.
Link:
View poster here
Poster #:
263
Title:
Metabolic Acidosis is Undertreated in
Patients with Chronic Kidney Disease.
Author:
N. Tangri et al.
Link:
View poster here
Poster #:
264
About Metabolic Acidosis
Metabolic acidosis is a chronic condition commonly caused by CKD
and is believed to accelerate the progression of kidney
deterioration. Metabolic acidosis is estimated to pose a health
risk to approximately three million patients with CKD in the United
States and currently there are no U.S. Food and Drug Administration
(FDA)-approved chronic therapies for treating metabolic acidosis.
Metabolic acidosis is a serious condition in which the body has
accumulated too much acid and occurs when a patient’s kidneys can
no longer excrete sufficient acid or produce enough bicarbonate to
balance acid production. The prevalence and severity of metabolic
acidosis in people with CKD progressively rises as kidney function
declines. As a chronic condition, metabolic acidosis is associated
with an increased risk of CKD progression and death. It is also
associated with an increased risk of muscle wasting and loss of
bone density.
About Tricida
Tricida, Inc. is a pharmaceutical company focused on the
development and commercialization of its drug candidate, veverimer
(TRC101), a non-absorbed, orally-administered polymer designed to
treat metabolic acidosis in patients with CKD. Metabolic acidosis
is a condition commonly caused by CKD that is believed to
accelerate the progression of kidney deterioration. It is estimated
to pose a health risk to approximately three million patients with
CKD in the United States. Tricida is currently conducting its
confirmatory postmarketing trial, VALOR-CKD, of veverimer. The
Tricida New Drug Application (NDA) for veverimer has been accepted
for review by the U.S. Food and Drug Administration (FDA) through
the Accelerated Approval Program. The FDA has assigned a
Prescription Drug User Fee Act (PDUFA) goal date of August 22,
2020.
For more information about Tricida, please visit www.Tricida.com.
Cautionary Note on Forward-Looking Statements
This press release includes forward-looking statements,
including for example, the potential timing for commercial launch
of veverimer, the assigned PDUFA goal date of August 22, 2020, and
the potential availability of the Accelerated Approval Program.
Forward-looking statements involve known and unknown risks,
uncertainties, assumptions and other factors that may cause our
actual results, performance or achievements to be materially
different from any future results, performance or achievements
expressed or implied by the forward-looking statements. These risks
and uncertainties include, among others, the cost, timing and
results of clinical trials and other studies; that many drug
candidates that have completed Phase 3 trials do not become
approved drugs on a timely or cost effective basis, or at all;
there can be no assurance that the FDA would approve an NDA through
the Accelerated Approval Program, or at all, and even if approval
for a drug is obtained, there can be no assurance that it will be
adopted in the market or accepted as a benefit to patients and
healthcare providers; possible safety and efficacy concerns; and
that we completely rely on third-party suppliers and manufacturers
for many aspects of our business. These and other factors that may
affect our future results of operations are identified and
described in more detail in our filings with the Securities and
Exchange Commission (SEC), including our Quarterly Reports on Form
10-Q and our Annual Report on Form 10-K. The forward-looking
statements contained in this press release reflect Tricida’s
current views with respect to future events, and Tricida does not
undertake and specifically disclaims any obligation to update any
forward-looking statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20200324005188/en/
Jackie Cossmon, IRC Tricida, Inc. Senior Vice President of
Investor Relations and Communications IR@Tricida.com
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