Tricida VALOR-CKD Phase 3 Trial Of Veverimer Fails To Meet Primary Goal; Stock Dips In Pre-market

Tricida, Inc. (TCDA) announced Monday that its VALOR-CKD renal outcomes clinical trial of Veverimer did not meet its primary endpoint. The clinical trial was designed to evaluate veverimer’s ability to slow CKD progression in patients with metabolic acidosis and chronic kidney disease or CKD.

In pre-market activity on Nasdaq, Tricida shares were losing around 94 percent to trade at $0.65.

The VALOR-CKD trial was an international, randomized, multicenter, double-blind, placebo-controlled trial of patients with CKD and metabolic acidosis.

The primary endpoint in the trial was defined as the time to the first occurrence of any event in the composite endpoint of renal death, end-stage renal disease or ESRD, or a confirmed greater than or equal to 40% reduction in estimated glomerular filtration rate (eGFR), also known as DD40.

The company noted that one hundred forty-nine veverimer-treated patients versus 148 placebo-treated patients experienced a DD40 primary endpoint event, representing a veverimer to placebo hazard ratio of 0.99 over the 26.7 months median duration of treatment.

In total, 2,198 patients received single-blind treatment with veverimer in Part A. Of these, 1,480 patients were randomized into Part B.

Gerrit Klaerner, Tricida’s Chief Executive Officer, and President, said, “Unfortunately, due to the higher than expected serum bicarbonate values in the placebo group, we were not able to compare an untreated acidotic population with a veverimer-treated population and were thus unable to assess veverimer’s ability to slow CKD progression. Given our past clinical experience with veverimer, and the VALOR-CKD trial design, we were surprised that there was not a greater separation in serum bicarbonate levels between the two groups. In light of the disappointing results from the trial, and our cash runway, we are evaluating next steps.”

Due to the failure on the primary endpoint, the prespecified hierarchical analysis did not permit statistical testing of the secondary endpoints, however, the nominal p-values for all of these endpoints were non-significant.

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