Ondine Biomedical's LANTERN Phase 3 Trial Meets Primary Endpoint, Showing 40% Reduction in Surgical Site Infections
核心洞察
Ondine Biomedical (搜索)'s LANTERN Phase 3 pivotal trial met its primary efficacy endpoint, with nasal photodisinfection plus standard of care associated with an estimated 40% relative reduction in 30-day surgical site infections (搜索) versus standard of care alone.
The study enrolled 5,188 patients across 18 hospitals in the United States and Canada, with no treatment-related serious safety concerns identified in the topline review.
Ondine plans to request a pre-New Drug Application meeting with the FDA and will present detailed findings at a scientific meeting and in peer-reviewed journals.
Ondine Biomedical (搜索) Inc. (AIM: OBI) has announced positive topline results from its LANTERN pivotal Phase 3 clinical trial, demonstrating that its non-antibiotic nasal photodisinfection technology significantly reduced surgical site infections (搜索) (SSIs) when added to standard of care. The trial met its primary efficacy endpoint, with the primary analysis estimating a 40% relative reduction in 30-day SSIs compared with standard of care alone.
The LANTERN (Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections (搜索)) study is a multicentre, cluster-randomised, crossover, controlled Phase 3 superiority study evaluating nasal photodisinfection in addition to standard of care versus standard of care alone for the prevention of surgical site infections. The trial enrolled a broad population of 5,188 patients undergoing major surgical procedures across 14 hospitals in the United States and four in Canada. Hospitals continued their usual standard of care infection-prevention practices, including permitted use of preoperative nasal mupirocin, presurgical antibiotics and other routine measures.
The primary analysis met the trial's prespecified Bayesian criterion for treatment benefit. The safety profile observed in LANTERN was consistent with more than a decade of prior clinical experience with nasal photodisinfection, including more than 250,000 patient treatments performed outside the United States. No treatment-related serious safety concerns were identified in the topline review; these findings remain subject to completion of detailed efficacy, safety, subgroup and other analyses.
Carolyn Cross, Chief Executive Officer of Ondine Biomedical (搜索), said: "The LANTERN results represent an important milestone for Ondine and for our development programme in surgical site infection prevention. Surgical site infections (搜索) remain a major cause of avoidable complications following surgery, while increasing antibiotic resistance makes prevention using non-antibiotic approaches increasingly important."
Cross added: "We are deeply grateful to the patients, investigators, clinical research teams and healthcare professionals at HCA Healthcare Research Institute and at four Canadian hospitals, whose joint participation made this large study possible. Our prior work in Canada and other countries over more than a decade has supported the potential benefits of nasal photodisinfection for patients and healthcare providers, and we look forward to engaging with the FDA through the regulatory process to bring this technology into the United States."
The Burden of Surgical Site Infections
Surgical site infections (搜索) remain one of the most serious complications of surgery, causing substantial patient morbidity, hospital readmissions, prolonged hospital stays and deaths. More than 300 million surgical procedures are performed globally each year, including more than 35 million major surgical procedures annually in the United States.
U.S. data have estimated that patients who develop an SSI face a two- to 11-fold increased risk of death compared with surgical patients without an infection. The economic burden is also substantial, with published U.S. estimates putting the annual healthcare cost of SSIs at approximately $3.5 billion to $10 billion. The CDC reports that an SSI can extend a patient's hospital stay by approximately 9.7 days and increase hospitalisation costs by more than $20,000 per admission.
How Nasal Photodisinfection Works
Ondine's nasal photodisinfection technology is a light-activated antimicrobial therapy designed to rapidly eliminate potentially pathogenic microorganisms in the nose, a major reservoir from which pathogens can spread to surgical sites and other parts of the body. Applied by a healthcare professional before surgery, the treatment uses a proprietary photosensitising agent activated by a specific wavelength of red light to produce a rapid antimicrobial effect through oxidative mechanisms.
Because the mechanisms are non-antibiotic and act through multiple oxidative pathways, nasal photodisinfection is designed to have a low potential for development of microbial resistance.
Regulatory Path Forward
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.
Ondine's lead product, branded as Steriwave outside the United States, is authorised for nasal decolonisation in Canada, the UK, and certain other international markets. In the United States, the technology has been granted Qualified Infectious Disease Product designation and Fast Track status by the FDA. The Company's nasal photodisinfection technology is not approved by the FDA and is not commercially available for sale in the United States, where it is limited by federal law to investigational use only.
The Company has a pipeline of additional photodisinfection products in various stages of development for application in areas including chronic sinusitis, ventilator-associated pneumonia, burns and other indications.