Ondine Biomed Regulatory News (OBI)

6 September 2022

Ondine Biomedical Inc.

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

Ondine reports successful US Phase 2 trial data

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

· 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.

Ondine Biomedical Inc. (LON: OBI) announces that its Phase 2 BENEFIT-APDT clinical trial 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 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.

Jason Hickok, VP of Clinical & Medical Affairs commented:

"We are pleased that the statistically significant results from the BENEFIT-APDT trial demonstrate the positive therapeutic effect of nasal photodisinfection. 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]

Nicolas Loebel, Ph.D, President of Ondine, commented:

"Preventing SSIs with the use of a single, 5-minute treatment that is safe, non-toxic, and non-antibiotic immediately prior to surgery is a completely new paradigm for hospitals.".

Ondine's nasal photodisinfection has a CE mark for use in the EU and is approved in Canada and several other countries under the name Steriwave™. In the US, it has received Qualified Infectious Disease Product designation and Fast Track status from the FDA and is currently undergoing clinical trials for regulatory approval.

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

For more information, please visit: www.ondinebio.com or contact: 

About Photodisinfection

Ondine's photodisinfection comprises a two-step process: the application of a proprietary light-activated solution 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 light exciting the photodynamic solution, causing an oxidative burst that is lethal to pathogens. A key benefit of this approach is that pathogens do not develop resistance to the therapy.

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.

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 several jurisdictions and has been awarded the CE mark, as well as Qualified Infectious Disease Product designation and Fast Track status in the US by the FDA.

The information contained within this announcement is deemed to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014, which is part of UK law by virtue of the European Union (Withdrawal) Act 2018. Upon the publication of this announcement, this inside information is now considered to be in the public domain.