Positive Results for CKD Compound

Full access

Tricida, a privately held company based in South San Francisco, announced positive results from its most recent trial, a Phase 3 study of TCRA-301 to examine the drug’s effects on metabolic acidosis in patients with chronic kidney disease (CKD). Tricida also filed for $150 million in an initial public offering to fund kidney drug approval.

Tricida’s new compound TRC101, a novel, non-absorbed polymer, is designed to bind hydrochloric acid in the gastrointestinal tract and remove it from the body through fecal excretion, thereby decreasing the total amount of acid in the body and increasing blood bicarbonate.

The TRCA-301 trial met its primary and secondary endpoints in a statistically significant manner (p <0.0001 for all primary and secondary endpoints) when compared with placebo, based on the initial analyses.

After 12 weeks, 59.2% of subjects in the TRC101 treatment group exhibited an increase in blood bicarbonate level of at least 4 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.

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).

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, the company reported.

Save