Tricida, Inc. announced results from its Phase 1/2 clinical study for its lead investigational drug candidate, TRC101, in 135 patients with chronic kidney disease (CKD) and metabolic acidosis. TRC101 represents a first-in-class approach to the treatment of metabolic acidosis, a common complication of CKD that can result in increased mortality, accelerated progression of kidney disease, progressive muscle breakdown and exacerbation of bone disease. TRC101 is a new chemical entity discovered and under development by Tricida. The non-absorbed, orally-administered polymer is designed to remove acid from the body with high capacity and specificity, with the objective to treat chronic metabolic acidosis associated with CKD as measured by an increase of patients’ serum bicarbonate levels. The double-blind, placebo-controlled study (TRCA-101, NCT02809183) evaluated the safety and efficacy of TRC101. All primary and secondary endpoints were met. Each of the three doses (3, 6 and 9 g) and both dosing regimens (once-daily and twice-daily) of TRC101 increased serum bicarbonate from baseline to the end of treatment (Day 15) in a highly statistically significant, which is consistent with a non-absorbed drug acting primarily within the gastrointestinal tract. No dose response was observed for any adverse event. Based on these results, Tricida plans to initiate a Phase 3 program to evaluate the safety and efficacy of TRC101 as a potential treatment for chronic metabolic acidosis associated with CKD.