Tricida's TRC101 meets in Phase III for CKD-associated metabolic acidosis

Tricida Inc. (South San Francisco, Calif.) said TRC101 met the primary and secondary endpoints in the double-blind, international Phase III TRCA-301 trial to treat metabolic acidosis associated with chronic kidney disease (CKD). The company plans to submit an NDA to FDA in 2H19 seeking accelerated approval of the candidate. TRC101 is a non-absorbed compound designed to treat electrolyte imbalances by selectively removing acid from the body.

On the 217-patient trial's primary endpoint, a significantly greater proportion of patients who received once-daily TRC101 achieved an increase in blood bicarbonate levels of at least 4 mEq/L or achieved blood bicarbonate levels in the normal range of 22-29 mEq/L after 12 weeks vs. placebo (59.2% vs. 22.5%, p<0.0001). TRC101 also met the secondary endpoint of increasing mean blood bicarbonate levels from baseline to week 12 vs. placebo (4.49 vs. 1.66 mEq/L, p<0.0001)...