Ondine treats first patients in Phase 2 FDA trial
7 February 2022
Ondine Biomedical Inc.
("Ondine Biomedical", "Ondine" or the "Company")
Ondine Biomedical treats first patients in nasal photodisinfection US Phase 2 for the prevention of post-operative infections
· 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.[i]
Ondine Biomedical Inc. (LON: OBI), has treated the first patients in its nasal photodisinfection exploratory Phase 2 trial . The study will evaluate how effectively the treatment eradicates pathogens - Staphylococcus aureus - in the nose, and the occurrence of surgical site infections (SSIs) within 30 days of surgery.
The single-center, BENEFIT-ADPT open-label study is being carried out at HCA Healthcare's Memorial Health University Medical Center in Savannah, Georgia and will involve up to 500 surgical patients.
Carolyn Cross, Ondine's CEO commented "We are delighted to be able to initiate this important study with the team at HCA Healthcare's Memorial Health University Medical Center. We are particularly pleased to start treating patients in light of the Omicron challenges, which have strained hospital resources and impacted clinical trials around the world. We appreciate HCA's support and the importance they place on reducing SSIs. This is a truly novel approach to nasal disinfection, and we believe that our technology has the potential to have a significant effect on combatting SSIs, complications, and extended hospital stays."
SSIs are the leading cause of readmissions to hospital following surgery and a significant cause of post-surgical morbidity and mortality, with approximately 3% of patients who contract an SSI dying as a consequence.
Prior to surgery, all clinical trial patients will undergo a nasal culture to determine the prevalence of Staphylococcus aureus, the main cause of surgical site infections. Each patient will then receive Ondine's nasal photodisinfection (investigational product) followed by a post-treatment culture, enabling evaluation of the efficacy of nasal photodisinfection across a wide range of patients and surgery types. Experience in Canada has found that the procedure has resulted in no major adverse reactions being reported.
Ondine's nasal photodisinfection is a patented platform technology involving a two-step process: the application of a light-activated agent 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 photodisinfection
process works by the light exciting the photodynamic agent, causing an oxidative burst that destroys pathogens - bacteria, viruses, and fungi. A key benefit of this approach is that pathogens do not develop resistance to the therapy.
Ondine's nasal photodisinfection has a CE mark for use in the EU and is approved in Canada and number of other countries under the name Steriwave
™
. In the United States, it has received Qualified Infectious Disease Product status and been granted Fast Track by the FDA.
The Phase 2 trial is part of the US FDA
regulatory application.
**ENDS**
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 any impact on human tissue.
Ondine has a pipeline of investigational products, based on its proprietary photodisinfection platform, in various stages of development. Products include treatment of chronic rhinosinusitis, decolonization of infections in burns and wounds, disinfection of endotracheal tubes to reduce the incidence of ventilator-associated pneumonia and most recently, the development of topical antiviral therapy for the upper respiratory tract to reduce viral titres and transmission of respiratory viruses (e.g., SARS-CoV-2, influenza, RSV, etc.). Ondine's technology is approved in a number of jurisdictions and has been awarded the CE mark, as well as Qualified Infectious Disease Product and Fast Track status in the US by the FDA.
For further Information, contact:
Ondine Biomedical Inc.
Carolyn Cross, CEO
Telephone: +1 604 669 0555
Arden Partners plc
Nominated Adviser and Broker
Ruari McGirr / Antonio Bossi
Telephone: +44 (0)20 7614 5900
Media Contact:
Simon Vane Percy
Telephone: +44 (0)7710005910
Email: simon@vanepercy.com / amanda@vanepercy.com
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