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Ondine Biomedical Presents Topline Results from Phase 3 LANTERN Trial

• Primary Bayesian analysis showed 40.5% lower risk of 30-day surgical site infection with a 98.2% probability of treatment benefit.
• Three standard frequentist models also reached statistical significance for the primary endpoint, with p-values between 0.016 to 0.022.
• Analysis of complete dataset ongoing, including secondary and exploratory endpoints.
• No treatment-related significant adverse events were noted.
• IMC session and live Q&A for investors and sell-side analysts to be held today at 16:30 BST to present the results.

Ondine Biomedical Inc. (AIM: OBI), a leader in light-activated antimicrobial therapies to prevent hospital infections, is today hosting an investor presentation of the topline results, including further statistical details, from its 5,188-patient Phase 3 LANTERN trial of nasal photodisinfection for the prevention of surgical site infections (“SSIs”). LANTERN was a group-randomised, standard-of-care-controlled, crossover trial conducted at 18 hospitals in the United States and Canada. It enrolled 5,188 patients undergoing a range of surgical procedures and evaluated whether preoperative nasal photodisinfection reduced the incidence of SSI within 30 days of surgery compared to standard-of-care.

The trial met its prespecified primary efficacy endpoint. The primary Bayesian analysis showed a 98.2% posterior probability that nasal photodisinfection reduced the risk of 30-day SSI compared to standard-of-care, including a permitted mupirocin nasal antibiotic regimen. The estimated risk ratio was 0.60 (95% credible interval: 0.33-0.97), corresponding to a 40.5% lower risk of SSI. No treatment-related significant adverse events were noted.

Three additional exploratory frequentist analyses were conducted, all of which supported the strength and consistency of the primary Bayesian finding. The frequentist analyses demonstrated odds ratios of 0.47 – 0.48, p=0.016 – 0.022 (95% CI’s: 0.25 – 0.88), each reaching conventional statistical significance. 

Ondine plans to request a pre-New Drug Application (“pre-NDA”) meeting with the U.S. Food and Drug Administration (“FDA”) to discuss the detailed LANTERN results and the Company’s planned future regulatory submissions. Detailed study findings will also be presented at a major scientific meeting and submitted for publication in one or more peer-reviewed medical journals.

Carolyn Cross, Chief Executive Officer of Ondine Biomedical, said:

“LANTERN has delivered strong and consistent Phase 3 topline results. LANTERN enrolled patients in a wide variety of facilities, from community hospitals to large metropolitan centers with hundreds of beds, and treated patients across many high-risk surgical categories such as neurosurgery, cardiac surgery and vascular surgery among others.

“There are more than 35 million major surgical procedures like these performed annually in the US, and surgical site infections continue to impose a substantial clinical and economic burden through avoidable complications, longer hospital stays, readmissions and higher costs of care.

“While nasal decolonization is already an established infection-prevention strategy, it primarily relies on nasal mupirocin, an antibiotic requiring 5 days of administration prior to surgery. This regimen creates practical compliance challenges and adds to concerns about antimicrobial stewardship. Ondine’s investigational nasal photodisinfection technology is designed to address these challenges through a non-antibiotic, healthcare professional-administered procedure delivered shortly before surgery. By moving nasal decolonisation into the standard hospital workflow, the approach is intended to support consistent administration at the point of care.”