Ondine completes enrollment for US Phase II nasal photodisinfection trial

Ondine Biomedical Inc. (LON: OBI), has recruited the final patient to its nasal photodisinfection exploratory Phase 2 trial. The trial is evaluating how effectively Ondine’s nasal photodisinfection technology eradicates pathogens – specifically Staphylococcus aureus – in the nose.

The single-center, BENEFIT-aPDT open-label study is being carried out at HCA Healthcare’s Memorial Health University Medical Center in Savannah, Georgia, and has recruited over 300 patients. Recruited patients undergo a pre-surgery nasal culture to determine the prevalence of Staphylococcus aureus, the main cause of surgical site infections.

Each patient then receives Ondine’s nasal photodisinfection (investigational product) followed by a post-treatment culture, enabling evaluation of the efficacy of nasal photodisinfection across a wide range of patients and surgery types.

Carolyn Cross, Ondine’s CEO commented “Completing patient recruitment on this Phase II trial is an important step in our clinical development, and we look forward to being able to share the trial results in due course. We appreciate HCA’s support throughout the trial, and their focus on the importance of reducing SSIs. Ours is a truly novel approach to nasal disinfection, and we believe that our technology has the potential to have a significant effect on combatting SSIs, complications, and extended hospital stays.”

SSIs are the leading cause of readmissions to hospital following surgery and a significant cause of post-surgical morbidity and mortality, with approximately 3% of patients who contract an SSI dying as a consequence. Post-operative infections occur in up to 300,000 patients per year in the United States and cost the US healthcare system tens of billions of dollars a year[i]. 

Ondine’s nasal photodisinfection is a patented platform technology involving a two-step process: the application of a light-activated agent to each nostril using a nasal swab, followed by illumination of the area with a specific wavelength of laser light for less than five minutes.

The photodisinfection process works by the light exciting the photodynamic agent, causing an oxidative burst that destroys pathogens – bacteria, viruses, and fungi. A key benefit of this approach is that pathogens do not develop resistance to the therapy. 

Ondine’s nasal photodisinfection has a CE mark for use in the EU and is approved in Canada and number of other countries under the name Steriwave™. In the United States, it has received Qualified Infectious Disease Product status and been granted Fast Track by the FDA. The Phase 2 trial is part of the US FDA regulatory application.