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Tricida has updated the expected date for reporting top-line results from the VALOR-CKD clinical trial of investigational drug candidate, veverimer, for chronic kidney disease (CKD) amid Ukraine crisis.
Nearly 15% of the subjects randomised in the trial are from Ukraine, the company noted.
The trial is analysing whether veverimer has the ability to decelerate the progression of chronic CKD in metabolic acidosis linked to the disease.
Veverimer is a non-absorbed, oral polymer intended to reduce CKD progression.
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With the latest development, top-line trial results are now expected early in the fourth quarter of this year.
As of 1 March, the trial had 197 subjects with positively adjudicated primary endpoint events following an average treatment period of nearly 23 months.
End-stage renal disease, or greater than or equal to a 40% reduction in estimated glomerular filtration rate and renal death were the primary endpoint events of the trial.
In a press statement, Tricida said: “Given the uncertainty around future participation of Ukrainian subjects in the trial and the potential challenges to collecting and monitoring data from Ukrainian sites, top-line data from the VALOR-CKD trial is now anticipated early in the fourth quarter of 2022, versus Tricida’s previous guidance of the third quarter of 2022.
The guidance for reporting trial data was revised by the company on analysing the present situation in the country.
Tricida expects that additional time is required to deal with predicted interruptions and/or delays in collecting data.
Furthermore, the company does not anticipate any impact on the usability of the results obtained from subjects in Ukraine.
The company believes that its financial resources will be sufficient for nearly six months after the expected reporting of top-line data from the study.
Tricida CEO and president Gerrit Klaerner said: “We are deeply concerned for the people of Ukraine, including the VALOR-CKD patients, investigators, site staff and our CRO colleagues who we have worked with for many years.
“We believe that an incremental delay of the administrative stop is prudent to obtain interpretable data from the VALOR-CKD trial with approximately the same number of events and six-months cash runway as outlined in our prior communications.”
