Ondine Biomedical Inc (AIM:OBI, OTC:OBIMF), the life sciences company, traded at 13.4p, up 14%, in early London trade following the release of successful phase 3 clinical trial results.
Positive topline data from the LANTERN study demonstrated the efficacy of the company's nasal photodisinfection technology in preventing surgical site infections.
Patients receiving the treatment alongside standard care experienced an estimated 40% relative reduction in surgical site infections within 30 days compared to standard care alone.
The trial met its primary efficacy endpoint and satisfied the prespecified Bayesian criterion for treatment benefit.
Clinical teams enrolled 5,188 patients undergoing major surgical procedures across 14 hospitals in the United States and four in Canada.
Participating hospitals maintained their usual infection prevention practices during the trial.
These practices included the permitted use of preoperative nasal mupirocin and presurgical antibiotics.
Researchers identified no treatment-related serious safety concerns during the topline review.
The safety profile aligns with more than a decade of previous clinical experience encompassing over 250,000 treatments administered globally.
Ondine Biomedical plans to request a pre-New Drug Application meeting with the United States Food and Drug Administration.
Management will use this meeting to discuss the trial results and outline future regulatory submissions.
Detailed study findings will feature at a major scientific meeting and undergo peer review for publication in medical journals.
The results mark a significant milestone for Ondine Biomedical and its surgical site infection prevention development programme.
Surgical site infections remain a major cause of avoidable complications following surgery.
This highlights the growing importance of non-antibiotic prevention methods amid rising antibiotic resistance.
The company expects to engage with the United States regulator to advance the technology towards market approval.
