Ondine Biomedical reports successful topline data from Phase 2 nasal photodisinfection trial

Results show a single, 5-minute treatment of nasal photodisinfection significantly reduces Staphylococcus aureus, a major cause of surgical site infections, in pre-surgical patients

• Top line results met primary endpoint and showed nasal photodisinfection eliminated or significantly decreased Staphylococcus aureus (S. aureus) in 92% of carriers treated per protocol (P<0.001).
•  All of the 319 subjects received a single, 5-minute nasal photodisinfection treatment.
•  S. aureus is the primary pathogen associated with surgical site infections (SSIs).[i]
•  No reportable adverse events

VANCOUVER, BC, Sept. 6, 2022 /PRNewswire/ -- Ondine Biomedical Inc. (LON: OBI) announces that its Phase 2 BENEFIT-APDT clinical trial has met the primary endpoint of bacterial load reduction after nasal photodisinfection. Results from the study showed that nasal photodisinfection eliminated or significantly decreased S. aureus in 92% of carriers (P<0.001) immediately after treatment. There were no reportable adverse events or unexpected safety issues; treatment was found to be safe and well tolerated.

Carolyn Cross, CEO of Ondine Biomedical, commented, "As expected, photodisinfection had a strong antimicrobial outcome, which we believe, from our Canadian hospital experiences, will be beneficial to pre-surgical patients. Concluding our Phase 2 trial is a key milestone that satisfies our IPO commitment and puts us firmly on the path towards completing the US FDA regulatory process."

The single-centre, BENEFIT-APDT open-label study was carried out at HCA Healthcare's Memorial Health University Medical Center in Savannah, Georgia. A total of 319 pre-surgical patients were enrolled and tested for the presence of S. aureus in the nose. Patients were then treated with a single, 5-minute nasal photodisinfection treatment and then re-tested.

"We are pleased that the statistically significant results from the BENEFIT-APDT trial demonstrate the positive therapeutic effect of nasal photodisinfection," said Jason Hickok, VP of Clinical & Medical Affairs. "This novel therapy has the potential to be an important new treatment option to combat surgical site infections."

Lowering surgical site infection rates has been an elusive target for hospitals for many years. Up to 30% of the general population is nasally colonized with S. aureus,[ii] significantly increasing the risk of surgery-related infections. SSIs are the leading cause of readmissions to hospital following surgery, and approximately 3% of patients who contract an SSI die as a consequence of these infections.[iii] 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.[iv]

Ondine expects the full results of the Phase 2 trial to be available in November 2022.

About Ondine Biomedical Inc.

Ondine Biomedical Inc. is a Canadian headquartered company led by founder and CEO, Carolyn Cross. Ondine has developed a patented, photodisinfection technology platform used in treatment and prevention therapies for a broad-spectrum of pathogens – including multidrug-resistant strains. Photodisinfection is a targeted antimicrobial which uses non-thermal light to activate a photosensitive agent. In a few minutes, this light-based therapy destroys the pathogens through an oxidative burst without harming human tissue.

[i] Klevens RM, Edwards JR, Richards CL, et al. Estimating healthcare associated infections and deaths in US hospitals, 2002. Public Health Rep 2007; 122:160e166.

[ii] Hidron AI, Edwards JR, Patel J, Horan TC, Sievert DM, Pollock DA, et al. NHSN annual update: antimicrobial-resistant pathogens associated with healthcare- associated infections: annual summary of data reported to the National Healthcare Safety Network at the Centers for Disease Control and Prevention, 2006-2007. Infect Control Hosp Epidemiol 2008;29:996 1011.

[iii] "Surgical Site Infections. PSNet Patient Safety Network, AHRQ. 2019.

[iv] "Surgical site infections are the most common and costly of hospital infections." ScienceDaily. 2017.

SOURCE Ondine Biomedical Inc.