Tricida Inc TCDA announced the topline results from its VALOR-CKD renal outcomes clinical trial, designed to evaluate veverimer’s ability to slow chronic kidney disease (CKD) progression.
The VALOR-CKD trial did not meet its primary endpoint, which was defined as the time to the first occurrence of any event in the composite endpoint of renal death, end-stage renal disease (ESRD), or a confirmed greater than or equal to 40% reduction in estimated glomerular filtration rate (eGFR), also known as DD40.
“In light of the disappointing results from the trial and our cash runway, we are evaluating the next steps,” said Gerrit Klaerner CEO & President.
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.
“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,” Klaerner commented.
The overall safety profile of veverimer observed in the trial was consistent with what was expected.
In May, Tricida stopped its VALOR-CKD renal outcomes trial early for administrative reasons under the existing study protocol to allow for six months of financial runway following topline results.
Price Action: TCDA shares are down 93.6% at $0.70 during the premarket session on the last check Monday.
