Tricida (NASDAQ:TCDA) announces the publication of results from a Phase 3 clinical trial, TRCA-301E, evaluating lead candidate veverimer (TRC101) for the treatment of metabolic acidosis in patients with chronic kidney disease (CKD). The data are in the latest online edition of The Lancet.
The study met the primary efficacy endpoint of a statistically significant proportion of treated patients achieving at least a 4 mmol/L increase in serum bicarbonate compared to placebo. Specifically, 63% of patients receiving veverimer hit the threshold versus 38% for control (p=0.0015). Higher bicarbonate concentrations were observed at all timepoints.
The safety profile was favorable. Serious adverse events occurred in 2% of the treatment group compared to 5% in the control group. The rate of renal system adverse events also favored veverimer, 8% vs. 15%.
Veverimer is a non-absorbed polymer that binds to hydrochloric acid in the GI tract and is removed through feces excretion, thereby lowering the amount of acid in the body.
The company expects to file a U.S. marketing application in H2.
Shares are up 2% premarket on light volume.
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