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Tricida Announces Multiple Data Presentations on Veverimer and Metabolic Acidosis to Be Given at the Virtual National Kidney Foundation 2020 Spring Clinical Meetings

·5 min read

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200324005188/en/

Contacts

Jackie Cossmon, IRC
Tricida, Inc.
Senior Vice President of Investor Relations and Communications
IR@Tricida.com