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Tricida, Inc. (NASDAQ: TCDA) has announced that its late-breaking clinical trial abstract for the Phase 3 VALOR-CKD renal outcomes trial will be presented at the American Society of Nephrology's Kidney Week 2022 in Orlando, Florida, from November 3-6, 2022. The presentation, titled “VALOR-CKD: A Multicenter, Randomized, Double-Blind Placebo-Controlled Trial Evaluating Veverimer in Slowing Progression of CKD in Patients With Metabolic Acidosis,” will take place on November 4, 2022. Top-line data from the trial is expected to be reported in October 2022. Veverimer aims to slow chronic kidney disease progression in patients with metabolic acidosis.
Positive
Late-breaking abstract selected for oral presentation at ASN Kidney Week 2022.
Presentation of Phase 3 VALOR-CKD trial may enhance investor confidence.
Potential for veverimer to address an unmet medical need in CKD treatment.
Negative
VALOR-CKD trial remains blinded, limiting current data transparency.
No unblinded information provided prior to data reporting.
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--
Tricida, Inc. (Nasdaq: TCDA) announced today that a late-breaking clinical trial abstract on the Phase 3, VALOR-CKD renal outcomes trial has been selected by the American Society of Nephrology (ASN) and the Kidney Week Education Committee for oral presentation in the High-Impact Clinical Trials session at the ASN Kidney Week 2022 meeting that is currently scheduled to take place November 3 to 6, 2022 in Orlando, Florida.
The presentation entitled “VALOR-CKD: A Multicenter, Randomized, Double-Blind Placebo-Controlled Trial Evaluating Veverimer in Slowing Progression of CKD in Patients With Metabolic Acidosis” will be given by Dr. Navdeep Tangri, M.D., Ph.D., F.R.C.P.(C), Professor of Medicine, Department of Medicine and Community Health Sciences, and Scientific Director, Chronic Disease Innovation Center, University of Manitoba. The session is currently scheduled as follows:
Session Date and Time: November 4, 2022, from 10:30 am to 12:30 pm
Session Title: High-Impact Clinical Trials
Session Room: W415 Valencia
Abstract Publication #: FR-OR65
Presentation Time: 11:30 AM to 11:45 AM
Tricida previously announced that it anticipates reporting of top-line data from the Phase 3 VALOR‑CKD renal outcome clinical trial in October 2022. At the present time, the VALOR-CKD trial remains blinded; the late-breaking clinical trials abstract that was chosen for presentation on November 4th contained no unblinded information.
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. It is estimated to pose a health risk to approximately 4.3 million patients with CKD in the United States. There are currently no therapies approved by the FDA to slow progression of kidney disease by correcting chronic metabolic acidosis in patients with CKD.
For more information about Tricida, please visit Tricida.com.
Cautionary Note on Forward-Looking Statements
This press release includes forward-looking statements, including for example, statements concerning the Company’s plans and expectations for the estimated timing for receipt of top-line data from the VALOR-CKD trial. These and other factors that may affect the Company’s future results of operations are identified and described in more detail in our filings with the Securities and Exchange Commission (the “SEC”). 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.
Jackie Cossmon, IRC
Tricida, Inc. Senior Vice President of Investor Relations and Communications
IR@Tricida.com
Source: Tricida, Inc.
FAQ
What is the VALOR-CKD trial about and when are the results expected?
The VALOR-CKD trial is a Phase 3 clinical trial evaluating veverimer's effectiveness in slowing chronic kidney disease progression in patients with metabolic acidosis. Top-line results are expected in October 2022.
Who is presenting the VALOR-CKD trial results at ASN Kidney Week 2022?
Dr. Navdeep Tangri, M.D., Ph.D., will present the trial results at the ASN Kidney Week 2022.
When will the VALOR-CKD trial be presented at ASN Kidney Week 2022?
The presentation is scheduled for November 4, 2022.
What is veverimer and its significance in chronic kidney disease treatment?
Veverimer is an investigational drug designed to slow CKD progression in patients with metabolic acidosis, addressing a significant unmet need as no FDA-approved therapies currently exist for this condition.
