Tricida Announces Multiple Data Presentations on Metabolic Acidosis to be Given at ASN Kidney Week 2019

October 2, 2019 Off By BusinessWire

SOUTH SAN FRANCISCO, Calif.–(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-dosed polymer designed to treat metabolic acidosis in patients with chronic kidney disease (CKD), announced today multiple presentations on metabolic acidosis that will be given at the upcoming American Society of Nephrology (ASN) Kidney Week 2019 meeting taking place November 5-10, 2019 in Washington, D.C.

Presentation Details:

Veverimer presentations will include clinical trial data from Tricida’s pivotal, Phase 3 extension trial, TRCA-301E, and data on the mechanism of action of veverimer:

Title:

Randomized, Controlled Trial of Long-Term Safety and Efficacy of Veverimer for Treatment of Metabolic Acidosis

Author:

D. Wesson et al.

Date/Time:

Thursday, November 7th / 10:00 a.m. to 12:00 p.m. ET

Poster #:

TH-PO448

Abstract #:

3226584

 

 

Title:

Mechanism of Action of Veverimer, a First-in-Class, Orally-Administered, Non-Absorbed, Counterion-Free Hydrochloric Acid Binder for the Treatment of Metabolic Acidosis in CKD

Author:

J. Shao et al.

Date/Time:

Saturday, November 9th / 10:00 a.m. to 12:00 p.m. ET

Poster #:

SA-PO765

Abstract #:

3230295

Studies will also be presented on the impact of metabolic acidosis on CKD, bone, muscle and cardiovascular outcomes and the healthcare system:

Title:

Association of Metabolic Acidosis with Adverse Cardiovascular Outcomes in Patients with Chronic Kidney Disease

Author:

N. Reaven et al.

Date/Time:

Thursday, November 7th / 10:00 a.m. to 12:00 p.m. ET

Poster #:

TH-PO693

Abstract #:

3231288

 

 

Title:

Metabolic Acidosis is Underdiagnosed and Undertreated in Patients with Chronic Kidney Disease

Author:

N Tangri

Date/Time:

Friday, November 8th / 10:00 a.m. to 12:00 p.m. ET

Poster #:

FR-PO632

Abstract #:

3231478

 

 

Title:

Metabolic Acidosis is an Independent Predictor of Adverse Renal Outcomes and Higher Costs in Patients with Chronic Kidney Disease

Author:

N. Reaven et al.

Date/Time:

Friday, November 8th / 10:00 a.m. to 12:00 p.m. ET

Poster #:

FR-PO274

Abstract #:

3231145

 

 

Title:

Metabolic Acidosis is Associated with Failure to Thrive and Fractures/Falls in Patients with Chronic Kidney Disease

Author:

N. Reaven et al.

Date/Time:

Saturday, November 9th / 10:00 a.m. to 12:00 p.m. ET

Poster #:

SA-PO836

Abstract #:

3231266

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. Tricida has submitted a New Drug Application seeking approval of veverimer through the FDA’s Accelerated Approval Program and is currently conducting its confirmatory postmarketing trial, VALOR-CKD.

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 approval of our NDA submission for veverimer under the FDA’s Accelerated Approval Program and the potential timing of the approval and commercial launch of veverimer. 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 will approve our NDA for veverimer under the Accelerated Approval Program, or at all, and even if approval for veverimer 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. 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 (the “SEC”), including our Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2019, filed with the SEC on August 8, 2019. You should not place undue reliance on these forward-looking statements. 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.

Contacts

Jackie Cossmon, IRC

Tricida, Inc.

Vice President of Investor Relations and Communications

[email protected]