Ondine Biomedical Inc. Ondine Phase 2 results presented at ECCMID 2023

TIDMOBI

Ondine Biomedical Inc.

18 April 2023

ONDINE BIOMEDICAL INC.

("Ondine Biomedical", "Ondine" or the "Company")

Ondine Phase 2 results presented at ECCMID 2023

Ondine Biomedical Inc. (LON: OBI) is presenting detailed results from its US Phase 2 BENEFIT-aPDT clinical trial to the 33(rd) European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Copenhagen, Denmark. The results indicate that patients who underwent Ondine's nasal photodisinfection prior to surgery experienced 66% fewer surgical site infections (SSIs) than the US national average. The Centers for Disease Control and Prevention (CDC) estimates that over 110,000 SSIs occur in the US each year, costing the healthcare system approximately $3.3 billion.([1])

Moreover, the study results show that Ondine's nasal photodisinfection eliminated or significantly reduced Staphylococcus aureus, including MRSA, in 88% of carriers immediately after treatment. Of the 313 patients who underwent the treatment prior to surgery, 21% were found to have S. aureus colonization in their nose. The nose is a well-known reservoir of infection-causing pathogens.([2])

Roger Andersen, MD, MPH, Ondine Biomedical's VP, Regulatory and Medical Affairs said:

"Our US Phase 2 trial met its primary endpoint last year, and these results confirm that a single, 5-minute treatment of nasal photodisinfection pre-surgically significantly reduces Staphylococcus aureus, a primary pathogen causing surgical site infections. These exciting results demonstrate the capabilities of this advanced infection prevention. Universal treatment with nasal photodisinfection before surgery could have a transformative effect on preventing SSIs and potentially lead to substantial cost savings for the US healthcare system."

All patients in the study were treated with a single, 5-minute treatment of Ondine's nasal photodisinfection, which eliminates infection-causing bacteria, viruses and fungi in the nose. Ondine's nasal photodisinfection is a patented technology which uses a proprietary, non-antibiotic photosensitizer to destroy pathogens. When illuminated with a specific wavelength of light, the photosensitizer is activated, causing an oxidative burst that is lethal to all types of pathogens.

The findings of the Phase 2 study were consistent with previously reported research from Vancouver General Hospital (VGH) showing that pre-surgical nasal photodisinfection resulted in a 78% reduction in SSIs among spine surgery patients.([3])

Ondine's nasal photodisinfection system has a CE mark and is approved in Canada and several other countries under the name Steriwave(TM). It has been used in numerous Canadian hospitals for over ten years, with no serious adverse events reported.

Ondine is currently preparing for a US Phase 3 trial of its nasal photodisinfection, with further details to be announced later this year.

 
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About the Phase 2 study

Ondine Biomedical's Phase 2 BENEFIT-APDT clinical trial was an IRB-approved study of 313 patients over the age of 18, conducted at HCA Healthcare's Memorial Health University Medical Center, Savannah Georgia, a 612-bed acute-care teaching hospital and Level 1 trauma centre. The study initiated on February 3, 2022 and ended September 7, 2022. The study met its primary endpoint of bacterial load reduction after nasal photodisinfection. There were no treatment-related reportable adverse events; treatment was found to be safe and well tolerated.

Please note that the number of participants in the study has been updated from 322 to 313 since the headline read-out in December 2022, which accounts for minor differences in the reported percentage results.

About Nasal Photodisinfection

Ondine's nasal photodisinfection is a patented technology using a proprietary photosensitiser (non-antibiotic, light-activated solution) to destroy pathogens. The photodisinfection treatment is carried out by a trained healthcare professional, and is an easy to use, painless, two-step process. The photosensitiser is applied 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 light activates the photosensitiser, causing an oxidative burst that is lethal to all types of pathogens. A key benefit of this approach, unlike with antibiotics, is that pathogens do not develop resistance to the therapy.

Nasal decolonisation with antibiotics is already standard practice in many hospitals prior to surgery, as pathogens in a patient's nasal cavities are a major cause of surgical site infections (SSIs). However, there is a growing need to reduce antibiotic use and find non-antibiotic methods of nasal decolonisation as resistance rates have been reported as high as 81%.[4]

Ondine's nasal photodisinfection system has a CE mark and is approved in Canada and several other countries under the name Steriwave(TM). It has been used in Canada for over ten years, with no serious adverse events reported. In the US, it is currently undergoing clinical trials for regulatory approval.

About Ondine Biomedical Inc.

Ondine Biomedical Inc. is a Canadian headquartered company innovating in the field of photodisinfection therapies. Ondine has a pipeline of investigational products, based on its proprietary photodisinfection platform, in various stages of development. Products beyond nasal photodisinfection include therapies for a variety of medical indications such as chronic sinusitis, ventilator-associated pneumonia, burns, and other indications.

[1] https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf

[2] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2908500/

[3] Daniel Banaszek, Tom Inglis, Tamir Ailon, Raphaële Charest-Morin, Nicolas Dea, Charles G. Fisher, Brian K. Kwon, Scott J. Paquette, John Street. The efficacy and cost-effectiveness of photodynamic therapy in prevention of surgical site infection,The Spine Journal, Volume 19, Issue 9, Supplement, 2019, Page S138, https://doi.org/10.1016/j.spinee.2019.05.299.

[4] Journal of Antimicrobial Chemotherapy, Volume 70, Issue 10, October 2015, Pages 2681-2692, https://doi.org/10.1093/jac/dkv169

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April 18, 2023 06:00 ET (10:00 GMT)