• TRC101 met both primary and secondary endpoints
• Partients reported improved quality of life scores
• Approximately 3 million patients in the US alone are at risk for CKD metabolic acidosis

Tricida, Inc. announced on 6/5/2018 results from its pivotal Phase 3 double-blind, randomized, placebo-controlled, multi-center Phase 3 clinical trial, TRCA-301, in 217 chronic kidney disease (CKD) patients with metabolic acidosis. TRC101 represents a first-in-class candidate for the treatment of metabolic acidosis, a common complication of CKD that can accelerate progression of kidney disease, increase the risk of muscle wasting and cause the loss of bone density.

Based on the initial topline analyses, the TRCA-301 trial met both its primary and secondary endpoints in a highly statistically significant manner (p < 0.0001 for all primary and secondary endpoints). TRC101 was well tolerated in the TRCA-301 trial. Both active (124 subjects) and placebo groups (93 subjects) had low discontinuation rates and low rates of treatment-related adverse events.

For the primary endpoint, after 12 weeks of treatment, 59.2% of subjects in the TRC101 treatment group exhibited an increase in blood bicarbonate level of at least 4 milliequivalents per liter (mEq/L) or achieved a blood bicarbonate level in the normal range of 22 to 29 mEq/L, compared with 22.5% of subjects in the placebo group (p< 0.0001). For the secondary endpoint, the mean change in blood bicarbonate from baseline to week 12, subjects in the TRC101 treatment group exhibited a mean increase in blood bicarbonate of 4.49 mEq/L, compared with 1.66 mEq/L in the placebo group (p<0.0001).

Patients also reported a statistically significant improvement in quality of life scores and a trend towards significance in a chair/stand test. The overall safety profile of TRC101 observed in the trial was consistent with that expected for the general population of patients with Stage 3 to 5 CKD and with similar non-absorbed polymer drugs with a site of action in the gastrointestinal tract.

TRC101 is a novel, non-absorbed polymer drug that is designed to bind hydrochloric acid in the gastrointestinal tract, removing it from the body with high capacity and specificity, with the objective to treat chronic metabolic acidosis associated with CKD as measured by an increase in blood bicarbonate levels.

There are more than 30 million patients in the US alone with CKD. Metabolic acidosis poses a significant health risk to approximately three million CKD patients in the United States.

In November of 2017 Tricida announced the closing of a $57.5 million series D round.