BioPorto (NASDAQ COPENHAG:BIOPOR) A/S said it has decided to continue enrolling pediatric patients for its clinical trial on moderate to severe acute kidney injury into the first half of 2022, extending data collection beyond its original goal of December 31, 2021.
The Copenhagen-listed firm said the coronavirus (COVID-19) pandemic has continued to impact hospital operations but added that the extended enrollment period does not alter its financial guidance for 2021.
“Despite our strong focus on engaging with the participating clinics, enrollment has been slower than planned as COVID-19 still affects the health care sector,” said Christopher Bird, BioPorto (NASDAQ COPENHAG:BIOPOR) chief medical officer in a statement.
“Based on actual enrollment figures and the outlook on COVID-19, we have revised our enrollment forecast and now expect to finish data collection in the first half of 2022,” he added.
The company said it wants to optimize the ongoing pediatric clinical trial’s statistical power for the upcoming submission to the US Food and Drug Administration (FDA). After enrollment is complete, BioPorto will continue to work interactively with the FDA to submit a De Novo Classification Request, as its NGAL Test maintains its Breakthrough Designation status.
The company has been aggressively marketing its proprietary NGAL Test, which provides an early risk assessment of acute kidney injury, a well-known complication that is common after surgeries such as kidney transplants and heart bypass.
BioPorto says its NGAL Test can detect acute kidney injury in critically ill patients as quickly as 2 hours.