- 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.
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