Ondine Biomedical Inc (AIM:OBI, OTC:OBIMF) rose 5% to 11.50p after its phase III LANTERN trial met the primary efficacy target for reducing surgical site infections.
The biotech's LANTERN trial met its prespecified primary efficacy endpoint, with the main analysis estimating a 41% reduction in surgical site infection risk within 30 days.
Giving weight to the trial's success, the primary Bayesian analysis showed a 98% probability of treatment benefit over standard care, including a permitted nasal antibiotic regimen.
Backing up those results, three exploratory statistical analyses also reached conventional significance, with p-values ranging from 0.016 to 0.022.
Across 18 hospitals in the United States and Canada, the trial enrolled 5,188 surgical patients, with no treatment-related significant adverse events reported.
The investigational treatment uses light-activated nasal disinfection shortly before surgery, offering a non-antibiotic approach administered by healthcare professionals within the hospital workflow.
By comparison, chief executive Carolyn Cross said nasal antibiotic mupirocin requires five days of administration before surgery, creating practical challenges for patients following the regimen.
As analysis of secondary and exploratory endpoints continues, Ondine will present topline findings and next steps to investors at 16:30 BST today.
Ondine now plans to seek a pre-application meeting with the US Food and Drug Administration to review the LANTERN findings and discuss future regulatory submissions
