Ondine Biomedical to start phase three Steriwave clinical trial

The AIM-traded firm said the trial was being launched on the back of the US Food and Drug Administration’s (FDA) acceptance of its investigational new drug (IND) amendment, with no objections raised during the 30-day statutory review period.

Preparations for the pivotal study were nearing completion, with 14 hospital sites selected and two backup sites identified.

Ondine said it had already initiated four sites, and started staff training to ensure readiness for patient enrolment.

Recruitment was now underway, and would continue into early 2025, with the final patient expected to enrol by mid-2025.

Early trial results were anticipated in autumn 2025.

The phase three trial, conducted in collaboration with HCA Healthcare, would involve around 5,000 surgical patients undergoing cardiac, orthopedic, vascular, neuro, or radical mastectomy procedures.

Ondine said the group-randomised crossover study would compare current infection prevention practices with and without its nasal photodisinfection technology.

The company described the technology as a five-minute, non-invasive nasal decolonisation procedure that rapidly eliminates infection-causing pathogens without antibiotics, avoiding contributions to antimicrobial resistance (AMR).

It said the process involves applying a photosensitive agent to the nostrils, followed by exposure to a specific wavelength of red light.

The light activates the agent, triggering an oxidative burst that destroys bacteria, viruses, and fungi in a single treatment.

Nasal decolonization is recommended in the World Health Organization’s 2016 guidelines for preventing surgical site infections, and by the Society for Healthcare Epidemiology of America, which updated its recommendations in May 2023 to include major surgical procedures.

“The significant recent funding has been pivotal in enabling us to move forward with the launch of our US phase three trial before the end of the year,” said chief executive officer Carolyn Cross.

“This critical study marks a key milestone in our pursuit of FDA approval for our nasal photodisinfection technology.

“We're thrilled by the strong engagement from our clinical trial investigators and hospital research teams and are excited to commence the trial with the support of our clinical trial partner, HCA Healthcare.”

At 1300 GMT, shares in Ondine Biomedical were up 0.65% at 7.8p.

Reporting by Josh White for Sharecast.com.