Ondine's LANTERN Phase III Trial Hits Primary Endpoint With 41% Reduction in Surgical Site Infections
核心洞察
Ondine Biomedical (搜索)'s phase III LANTERN trial met its prespecified primary efficacy endpoint, estimating a 41% reduction in surgical site infection risk within 30 days.
The primary Bayesian analysis showed a 98% probability of treatment benefit over standard care, including a permitted nasal antibiotic regimen.
Three exploratory statistical analyses also reached conventional significance, with p-values ranging from 0.016 to 0.022, across 5,188 patients at 18 hospitals.
Ondine Biomedical (搜索) Inc (AIM:OBI, OTC:OBIMF) reported that its phase III LANTERN trial met its prespecified primary efficacy endpoint for reducing surgical site infections (搜索), sending the company's shares up 5% to 11.50p. The main analysis estimated a 41% reduction in surgical site infection risk within 30 days.
The primary Bayesian analysis showed a 98% probability of treatment benefit over standard care, which included a permitted nasal antibiotic regimen. Three exploratory statistical analyses also reached conventional significance, with p-values ranging from 0.016 to 0.022, reinforcing the primary result.
Trial Design and Population
LANTERN enrolled 5,188 surgical patients across 18 hospitals in the United States and Canada. No treatment-related significant adverse events were reported in the trial.
The investigational treatment uses light-activated nasal disinfection administered shortly before surgery, offering a non-antibiotic approach delivered by healthcare professionals within the hospital workflow.
Positioning Against Nasal Antibiotic Prophylaxis
Chief executive Carolyn Cross contrasted the investigational approach with nasal antibiotic mupirocin, which she said requires five days of administration before surgery, creating practical challenges for patients following the regimen.
Next Steps and Regulatory Path
Analysis of secondary and exploratory endpoints is continuing. Ondine said it will present topline findings and next steps to investors at 16:30 BST today, and now plans to seek a pre-application meeting with the US Food and Drug Administration (搜索) to review the LANTERN findings and discuss future regulatory submissions.