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Press Release

Tricida to Present at 36th Annual J.P. Morgan Healthcare Conference

Posted on: 21 Dec 17

Tricida, Inc. today announced that its management will be presenting at the 36th Annual J.P. Morgan Healthcare Conference on Tuesday, January 9, 2018 in San Francisco, California. The presentation is scheduled for 7:30 am PST.

About Tricida

Tricida, Inc. is a privately-held, clinical stage, biopharmaceutical company focused on the discovery and development of non-absorbed oral drug therapies. Tricida’s lead investigational drug candidate, TRC101, represents a first-in-class approach for the treatment of metabolic acidosis, a common complication of chronic kidney disease (CKD) that can result in accelerated progression of kidney disease, progressive muscle breakdown, exacerbation of bone disease, and an increased rate of mortality. In January 2016, the FDA accepted Tricida’s Investigational New Drug (IND) application for TRC101. The company has since successfully completed a Phase 1/2 double-blind, placebo-controlled study (TRCA-101) in which the safety, tolerability and efficacy of TRC101 were evaluated in subjects with CKD and low serum bicarbonate. Tricida is currently conducting a Phase 3 study (TRCA-301) of TRC101 for the treatment of metabolic acidosis associated with CKD designed to serve as the basis for the submission of a U.S. New Drug Application for TRC101 under the FDA’s accelerated approval pathway.

About TRC101

TRC101, a new chemical entity discovered by Tricida, is being developed as a first-in-class, orally administered, counterion-free, insoluble, non-absorbed polymeric drug for the treatment of metabolic acidosis in patients with CKD.

About the TRCA-301 Study

TRCA-301 is a randomized, double-blind, placebo-controlled, multicenter trial that is evaluating the efficacy and safety of TRC101 in subjects with CKD and metabolic acidosis. The trial is expected to enroll approximately 210 subjects at 54 sites and is evaluating a 12-week, once-a-day course of treatment with TRC101 compared to placebo, followed by a blinded, placebo-controlled 40-week extension study. The key efficacy endpoints of Study TRCA-301 are based on the change in blood bicarbonate from baseline to the end of treatment. The trial is expected to be completed in the second quarter of 2018.

About CKD and Metabolic Acidosis

In the United States, approximately 1 in 7 adults has CKD, a progressive and often-times debilitating disease. Patients with CKD may have a reduced ability to excrete acid generated by intrinsic and dietary metabolism, especially protein metabolism, resulting in metabolic acidosis. Metabolic acidosis results in lower blood pH and decreased blood bicarbonate levels. Chronic metabolic acidosis can lead to accelerated progression of kidney disease, progressive muscle breakdown, exacerbation of bone disease, and an increased rate of mortality. In the United States, chronic metabolic acidosis affects a significant percentage of CKD patients resulting in approximately 3 million to 4 million adults with chronic metabolic acidosis. There are no FDA-approved treatments for chronic metabolic acidosis.

Cautionary Note on Forward-Looking Statements

This press release includes forward-looking statements, including, for example, potential therapeutic capabilities, potential medical need and market size, and our expected timeline of development. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. For example, many drug candidates entering Phase 3 trials do not become approved drugs. 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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Last updated on: 21/12/2017

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