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.
Ondine Biomedical Inc.
+001 (604) 838
Angelika Vance, Corporate Communications 2702
Singer Capital Markets (Nominated Adviser
and Joint Broker)
+44 (0)20 7496
Aubrey Powell, Asha Chotai, Sam Butcher 3000
RBC Capital Markets (Joint Broker)
+44 (0)20 7653
Rupert Walford, Kathryn Deegan 4000
Vane Percy & Roberts (Media Contact)
+44 (0)77 1000
Simon Vane Percy, Amanda Bernard 5910
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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