Update on US Phase 3 Pivotal Study
Phase 3 LANTERN study endpoint adjudication complete; top-line results expected within one to two weeks.
- LANTERN study patients enrolled 5,188
- HCA Healthcare hospitals (US) 14
- Canadian study sites 4
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Ondine Biomedical Inc. (AIM: OBI), a leader in light-activated antimicrobial therapies to prevent and treat hospital infections, today provides an update on its LANTERN Phase 3 pivotal study evaluating the Company's non-antibiotic nasal photodisinfection technology (branded as Steriwave® outside the US).
Endpoint adjudication has been completed, all queries resolved, and site principal investigators are signing all case books which is a required administrative step towards database lock. This is expected to complete within the coming week, and once complete, the locked dataset will be transferred to statistical analysis in accordance with the Statistical Analysis Plan ("SAP"). The Company expects to report top-line results within one to two weeks thereafter.
The LANTERN (Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections) study is designed to evaluate the safety and efficacy of Ondine's nasal photodisinfection technology in reducing the rate of surgical site infections ("SSIs"). Conducted in collaboration with HCA Healthcare and select Canadian hospitals, the study enrolled 5,188 patients across 14 HCA Healthcare hospitals in the United States and four sites in Canada.
About Ondine Biomedical Inc.
U.S. Regulatory Status and Clinical Data Disclaimer
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