Ondine Biomedical (AIM:OBI), developer of light-activated antimicrobial therapies used to prevent hospital infections, said topline results from its LANTERN Phase 3 pivotal study are now expected within approximately six weeks.
The AIM-listed company said the delay reflects guidance from its independent data management and statistical advisers on the time needed to complete final data reconciliation and database lock, ahead of a regulatory submission.
The primary endpoint and success criteria are unchanged.
The trial tests Ondine's nasal photodisinfection technology, branded Steriwave outside the US, in reducing surgical site infections.
Conducted with HCA Healthcare and Canadian hospital partners, LANTERN enrolled 5,188 patients across 14 HCA Healthcare hospitals in the US and four Canadian sites.
"The LANTERN study includes more than 350,000 data points sourced from 18 hospitals," said Carolyn Cross, chief executive of Ondine Biomedical.
"We are encouraged by the progress being made and believe results may be available ahead of the revised schedule," she said.
Cross added that Ondine continues expanding Steriwave's use in hospitals and surgical specialities in markets where it is already approved.
