Ondine enrols first patient in phase three clinical trial

The AIM-traded company said the trial, which would involve around 5,000 patients across 14 hospitals, started with the enrollment of the first patient at Centennial Medical Center in Nashville, Tennessee, on 27 December.

It said the study was being conducted in collaboration with US healthcare provider HCA Healthcare, and would evaluate Ondine's non-antibiotic nasal photodisinfection technology, known as ‘Steriwave’ outside the United States.

The randomised crossover study would compare standard infection prevention practices with and without the technology in patients undergoing major surgical procedures, including cardiac, orthopedic, and neurosurgical operations.

Ondine said the trial was expected to finish enrollment by the middle of 2025, with preliminary results anticipated in the autumn.

It described its nasal photodisinfection as a five-minute, non-invasive procedure that eliminates pathogens from the nose without the use of antibiotics, reducing the risk of antimicrobial resistance.

The process involved applying a photosensitive agent to the nostrils, followed by illumination with red light to activate an oxidative burst that destroys bacteria, viruses, and fungi.

It said that approach was aligned with recommendations from the World Health Organization and the Society for Healthcare Epidemiology of America.

“Our US phase three trial initiation is an exciting milestone towards making photodisinfection technology available to healthcare professionals who want to rapidly eliminate a broad spectrum of infection-causing pathogens without fuelling drug resistance or relying on patient compliance as is the case with topical antibiotics,” said chief executive officer Carolyn Cross.

At 0824 GMT, shares in Ondine Biomedical were up 5.59% at 8.98p.

Reporting by Josh White for Sharecast.com.