Ondine Biomedical Inc.

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

Ondine reports full results from Phase 2 trial

Full results confirm that a single, 5-minute treatment of nasal photodisinfection significantly reduces Staphylococcus aureus, a major cause of surgical site infections, in pre-surgical patients.

·    The nasal photodisinfection study met the primary endpoint. Staphylococcus aureus (S. aureus) was eliminated or significantly decreased in 86% of carriers (p<0.001) in the trial.

·    The study also met the secondary endpoint. Analysis of follow up data demonstrated that treated patients showed a substantially lower surgical site infection (SSI) rate than the US national average (0.6 vs 3%).

·    S. aureus is the primary pathogen associated with surgical site infections (SSIs).[1]

·    There were no treatment-related reportable adverse events.

Ondine Biomedical Inc. (LON: OBI) reports the full results of its Phase 2 BENEFIT-PDT clinical trial, which met the primary endpoint of bacterial load reduction after nasal photodisinfection. The anterior nares (nostrils) are considered a primary reservoir of pathogens including Staphylococcus aureus and multidrug-resistant S. aureus (MRSA) - the leading cause of surgical site infections.  After all patients were included in the analysis, including those enrolled but not treated due to rescheduled surgeries, Photodisinfection was found to have eliminated or significantly decreased S. aureus in 86% of carriers (p<0.01). The secondary endpoint was also met, demonstrating a far lower surgical site infection (SSI) rate among treated patients versus the US historical national average SSI rate (0.6% vs 3%).[2]  There were no treatment-related reportable adverse events; treatment was found to be safe and well tolerated.

Dr. Simon Sinclair, Non-executive Director of Ondine, and former medical director J&J Medical Devices EMEA, said: "This study demonstrates that Ondine's photodisinfection technology robustly reduces nasal S. aureus colonisation in presurgical patients. Proving that this technology works well in a safe and easy-to-apply format is a critical step in our FDA regulatory pathway, and we hope will ultimately lead to wide utility across worldwide healthcare systems."

This Institutional Review Board (IRB)-approved study of 319 treated patients over the age of 18 was conducted at HCA Healthcare's Memorial Health University Medical Center in Savannah, Georgia, USA, a 612-bed acute-care teaching hospital and Level 1 trauma centre.  Prior to the photodisinfection treatment, each patient received a baseline nasal culture to determine S. aureus carrier status. The photodisinfection treatment consisted of swabbing each nostril with a proprietary light-activated solution followed by four minutes of non-thermal red laser light painlessly illuminating the area using single-use nasal light diffusers.  A second nasal culture was collected immediately following treatment to determine treatment effectiveness.  Patients were monitored within 24 hours, and then at 14 days and 30 days to determine the incidence of adverse events and SSIs.

Lowering SSI rates has been an elusive target for hospitals for many years as SSI's are the leading cause of readmissions to hospital following surgery with approximately 3% of patients who contract an SSI dying as a consequence of these infections.² Up to 30% of the general population is nasally colonized with S. aureus, significantly increasing the risk of surgery-related infections.[3] 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.[4]

Study details (https://clinicaltrials.gov/ct2/show/NCT05090657)

The study included patients with a broad range of surgeries including breast, gynaecological, orthopaedic, general, cardiothoracic, and head and neck. Population demographics included 190 females and 132 males for a total sample size of 322 enrolled patients across a range of ethnicities. Two patients did not receive treatment because their surgery was rescheduled and one patient discontinued the study. 75% of the subject population were white, 22% were Black/African American, and the balance were other ethnicities.  Patient ages ranged from 18 to 94 with a range of body mass indices from 14 to 65.  Most patients presented for surgery with low to moderate acuity (ASA score of 3 or less).  All patients presenting for surgery to the hospital were eligible for inclusion with the exception of patients with certain allergies, those less than 18 years of age, or those with significant anatomical nasal obstructions.  The study Principal Investigator was Stephen A. Thacker, MD, Paediatric Infectious Disease, and Co-Principal Investigator was Mary Downing, MD, Internal Medicine. The sub-Principal Investigator was Christopher Senkowski, MD, Complex General Surgery / Oncology.  The study was conducted by hospital research personnel and independently monitored by Janice Elsner, Senior Clinical Research Associate (Elite Research Consulting LLC, Noblesville, IN).  Microbiological assessments were performed by Quest Diagnostics, Tucker, GA an independent national clinical laboratory.  Patient recruitment was conducted by hospital personnel as well as a centralized team of research coordinators located at HCA Healthcare Research Institute, Nashville, Tennessee, USA. 

About Nasal Photodisinfection

Ondine's nasal 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 (Watch video here:  www.ondinebio.com/technology). A key benefit of this approach, unlike with antibiotics, is that pathogens do not develop resistance to the therapy. Photodisinfection is also known in the scientific community as antimicrobial photodynamic therapy (aPDT).

Ondine's nasal photodisinfection has a CE mark for use in the EU and is approved in Canada and several other countries, including the UK, 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 US regulatory approval.

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.).

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.