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Tricida begins phase 3 study of TRC101 to treat metabolic acidosis associated with chronic kidney disease

Published 29 September 2017

Tricida announced that the first subject was enrolled in TRCA-301, a phase 3 study evaluating TRC101 in chronic kidney disease (CKD) patients with metabolic acidosis.

Tricida plans to report topline results from this study in the second quarter of 2018.

If successful, TRCA-301 will serve as the pivotal trial for the submission of a U.S. New Drug Application (NDA) for TRC101 under the FDA’s accelerated approval pathway. A confirmatory post-marketing study for TRC101 following the completion of the TRCA-301 Phase 3 study is also planned.

“We are excited for the initiation of our pivotal Phase 3 study, TRCA-301,” said Klaus Veitinger, M.D., Ph.D., Chairman of Tricida.

 “Based upon the results of our successful TRCA-101 Phase 1/2 study and given that TRCA-301 has a similar design with a longer treatment period of 12 weeks versus 2 weeks, we are confident that subjects treated with TRC101 will show clinically meaningful increases in blood bicarbonate in the TRCA-301 study.”

"Chronic metabolic acidosis associated with CKD is a serious medical condition and represents a significant unmet medical need as there are no FDA-approved therapies,” said Gerrit Klaerner, Ph.D., Chief Executive Officer and President of Tricida.

 “We believe that a confirmatory post-marketing study following the TRCA-301 trial will demonstrate that the increases in blood bicarbonate in subjects treated with TRC101 will translate into clinical benefit, specifically the slowing of CKD progression.”

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

TRCA-301 is a randomized, double-blind, placebo-controlled, multicenter trial that will evaluate the efficacy and safety of TRC101 in subjects with chronic kidney disease and metabolic acidosis. The trial is expected to enroll approximately 210 subjects at 54 sites.

TRCA-301 will evaluate 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 are based on the change in blood bicarbonate from baseline to the end of treatment.

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 metabolism of food, especially protein, 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, an increased rate of mortality, progressive muscle breakdown and exacerbation of bone disease. 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.

Tricida, Inc. is a privately-held, clinical stage, biopharmaceutical company focused on the discovery and development of non-absorbed therapies.

Tricida’s lead investigational drug candidate, TRC101, represents a first-in-class approach to the treatment of metabolic acidosis, a common complication of chronic kidney disease (CKD) that can result in accelerated progression of kidney disease, an increased rate of mortality, progressive muscle breakdown and exacerbation of bone disease.

In January 2016, the FDA accepted Tricida’s Investigational New Drug (IND) application for TRC101 and the company has since successfully completed a Phase 1/2 double-blind, placebo-controlled study in which the safety, tolerability and efficacy of TRC101 were evaluated in subjects with chronic kidney disease and low serum bicarbonate.

Source: Company Press Release