Ondine Biomedical Inc. (AIM: OBI) said Wednesday its Phase 3 LANTERN trial met the primary endpoint, demonstrating that preoperative nasal photodisinfection reduced the risk of surgical site infections compared with standard care.
The group-randomized, crossover trial enrolled 5,188 patients undergoing various surgical procedures across 18 hospitals in the United States and Canada. Standard care included a permitted mupirocin nasal antibiotic regimen.
A primary Bayesian analysis yielded a posterior probability of 98.2% that nasal photodisinfection reduced the risk of 30-day surgical site infections. The estimated risk ratio was 0.60, with a 95% credible interval of 0.33 to 0.97, corresponding to a 40.5% lower risk of infection versus standard care.
Three exploratory frequentist analyses produced odds ratios ranging from 0.47 to 0.48, with p-values between 0.016 and 0.022 and 95% confidence intervals of 0.25 to 0.88.
No treatment-related significant adverse events were reported during the trial.
Ondine plans to request a pre-New Drug Application meeting with the U.S. Food and Drug Administration to review the detailed LANTERN results and planned regulatory submissions. Analysis of the complete dataset, including secondary and exploratory endpoints, remains ongoing. Detailed study findings will be presented at a scientific meeting and submitted for publication in peer-reviewed medical journals.
The company hosted an investor presentation on Wednesday at 16:30 BST via Investor Meet Company to review the topline results and statistical details.
