Tricida reaches the end of the road

The abject failure of the Valor-CKD trial, which tested Tricida’s veverimer in metabolic acidosis, shows that the FDA was right to refuse the project accelerated approval two years ago. Back then, the agency had concerns about the reproducibility of the the earlier TRCA-301/301E study, as well as wider worries about the surrogate biomarker being used to justify veverimer’s efficacy. Serum bicarbonate is a measure of blood acidity that Tricida maintains is a risk factor for the progression of chronic kidney disease. Today’s results arguably validate both the FDA's fears. Patients switched from drug to placebo unexpectedly maintained high serum bicarbonate levels, so no treatment effect could be found versus the active arm on any endpoint, primary or secondary, including hard measures like time to end stage renal disease and death. Executives were at a loss to explain the placebo results, ruling out the residual effects of a run-in period in which all patients got veverimer. Why the readings differed from TRCA-301/301E could also not be explained. What Tricida has shown is damning: that it cannot establish a predictable baseline patient group against which to compare veverimer. The 94% plunge in Tricida’s stock shows that investors are calling this the end of the road.