Our investigational drug, TRC101 is a novel, non-absorbed polymer that is designed to treat metabolic acidosis by binding hydrochloric acid in the gastrointestinal tract and removing it from the body through excretion in the feces, thereby decreasing the total amount of acid in the body and increasing blood bicarbonate. TRC101 is administered orally as a suspension in water. It was specifically designed to combine high capacity and high selectivity for binding and removing hydrochloric acid. Importantly, TRC101 does not deliver sodium or other counter-ions, potentially allowing for chronic treatment of metabolic acidosis in chronic kidney disease (CKD) patients with common comorbidities such as hypertension, cardiovascular disease, heart failure or edema.
Tricida has successfully completed a pivotal Phase 3, double-blind, placebo-controlled trial of TRC101 in 217 CKD patients with metabolic acidosis (TRCA-301) that evaluated the safety, tolerability and efficacy of TRC101 in CKD patients with metabolic acidosis. The primary and secondary efficacy endpoints of the TRCA-301 trial were based on the change in blood bicarbonate from baseline to the end of treatment (12 weeks) in TRC101-treated subjects compared to placebo. The trial met these endpoints with high statistical significance (p < 0.0001). The trial also showed significant improvement versus placebo (p < 0.0001) in patient reported physical functioning and a trend towards improvement on an objective measure of muscle function, which were pre-specified exploratory endpoints. TRC101 was well-tolerated in the TRCA-301 trial. Both the TRC101 and placebo groups had low discontinuation rates and low rates of treatment-related adverse events. Eligible subjects that completed the TRCA-301 trial were invited to participate in a 40-week safety extension trial, TRCA-301E.
Previously, we completed a successful 135-subject, double-blind, randomized, placebo-controlled Phase 1/2 trial, TRCA-101, and the results from this trial were published in an article, titled “Randomized, Controlled Trial of TRC101 to Increase Serum Bicarbonate in Patients with CKD,” by Bushinsky et al., in the Clinical Journal of the American Society of Nephrology (CJASN).
The results of the TRCA-301 trial along with results from our Phase 1/2 trial and our ongoing safety extension trial, TRCA-301E, are intended to serve as the basis for the submission of a U.S. New Drug Application (NDA) for TRC101 under the Accelerated Approval Program of the U.S. Food and Drug Administration (FDA). Pursuant to the Accelerated Approval Program, we plan to conduct a confirmatory postmarketing trial, VALOR-CKD (TRCA-303), to assess the effect of TRC101 on the slowing of CKD progression. *
*Please review our Forward Looking Statements for information regarding the risks and uncertainties related to these statements.