ONDINE BIOMEDICAL INC. (AIM: OBI)

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

Ondine's APDT reduces SARS-CoV-2 infectivity

Ondine's nasal photodisinfection therapy (APDT) improves short-term and long-term immune response while significantly reducing SARS-CoV-2 infectivity

Ondine Biomedical Inc. (LON:OBI) announces publication of the first randomized, placebo-controlled, single-blind clinical study of Steriwave™ nasal photodisinfection in 75 predominantly vaccinated COVID-19 patients. 

The study, published in Frontiers in Cellular and Infection Microbiology,_[1] met its primary endpoint, with a highly significant decrease in viral infectivity recorded as early as two days after treatment (p<0.0001). By contrast, patients in the placebo control arm, who underwent simulated treatment without the active components being applied, were non-responsive (p=0.24). No serious adverse events were reported. 

Steriwave therapy also significantly improved the immune-protective status of treated patients, as measured by PCR testing one week after treatment (over 6 times fewer PCR-positive patients compared to controls).  These results were paralleled by significant improvement in the patient-reported symptoms of chest tightness and headache.

The study was conducted at the Clínica Universidad de Navarra, a tertiary teaching hospital in Pamplona, Spain during the highly contagious sixth Omicron (B.1.1.529) outbreak in late 2021 / early 2022. This sixth SARS-CoV-2 wave in Spain was characterized as a "perfect storm" resulting in record numbers of new infections due to the combination of fewer restrictions in place, waning immunity offered by COVID-19 vaccines and the more contagious Omicron strain. Over 90% of the patients recruited into the study were fully vaccinated.

In an important additional finding, study researchers demonstrated that Steriwave photodisinfection substantially prolonged patient immunity against SARS-CoV-2 at 20 weeks after treatment.  This effect was detectable not only in antibody-mediated immunity (short-term antibody response to infection, or to mRNA vaccines, which fades relatively quickly), but also in T-cell mediated immunity (the long-term immune system "memory" capable of rapidly responding to future viral infections). 

Lead author, Co-Principal investigator, and Head of Occupational Medicine at the Clínica Universidad de Navarra Dr. Alejandro Fernandez-Montero commented "This randomized, controlled study shows that photodisinfection could be an effective and safe novel treatment for SARS-CoV-2 carriers, significantly decreasing the infectivity period. Most exciting is the demonstration of an adaptive immune response in treated patients. This is the basis of vaccination, and it means that nasal decolonization might provide an alternative, low-cost, widely accessible, respiratory virus treatment during future pandemics. The treatment specifically helped to maintain, over time, the cell-mediated immunity, which is remarkable as this is the immune protection needed against severe disease."

Dr. José Luis Del Pozo, Head of Infectious Diseases Division and Clinical Microbiology at the Clínica Universidad de Navarra, Co-Principal Investigator, and Study Author, commented "This study expanded our understanding of SARS-CoV-2 pathogenesis, because interestingly, we showed that treatment with aPDT applied only to the nasal passages also reduced SARS-CoV-2 colonization of the nasopharyngeal region. This implies that we might be able to slow viral spread from the upper to the lower respiratory tract, reducing the extent of illness and thereby reducing pressure on hospital facilities such as the ICU.  It also means that we might be able to slow or inhibit viral spread from person to person during an outbreak, in both clinical and non-clinical settings, even when those patients have been previously vaccinated."

Carolyn Cross, Ondine Biomedical's CEO stated " The Clínica Universidad de Navarra study sheds new light on the photodisinfection treatment of respiratory viruses, where antibiotics are entirely ineffective and new anti-viral therapies are limited. As new SARS-CoV-2 variants rapidly emerge across the globe, we look forward to being able to play our part in helping our communities, hospitals, clinics, and emergency workers deal with these new threats."

About Ondine Biomedical Inc.

Ondine Biomedical Inc. is a Canadian life sciences company innovating in the field of photodisinfection therapies. Photodisinfection (also known as antimicrobial photodynamic disinfection therapy or APDT) was originally developed by Professor Michael Wilson at University College London.

Ondine has developed a patented, painless, rapid, photodisinfection technology platform which can be used in the development of prevention and treatment therapies for a broad-spectrum of pathogens -including bacterial, viral, and fungal species, multidrug-resistant strains, and emerging threats such as the virulent hospital microbe, Candida auris. Ondine Biomedical Inc. has seven products under various stages of development including treatment of chronic rhinosinusitis, treatment of 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 transmission of SARS-CoV-2.

Ondine's nasal photodisinfection technology is approved in a number of jurisdictions under the brand name Steriwave™. Steriwave has been deployed in Canadian hospitals for over ten years in the prevention of hospital-acquired infections and has been recognized with a number of awards. Steriwave has been registered with a CE mark and has been granted Qualified Infectious Disease Product designation and Fast Track status in the US by the FDA. Steriwave is not currently available in the USA.

About the Clínica Universidad de Navarra, Pamplona, Spain

With over 3,000 professionals working exclusively at its headquarters in Pamplona and Madrid, the Clínica Universidad de Navarra is a leading research hospital in Spain in the field of personalised medicine.  The Clinic is recognized for both its teaching and research work, as well as the prestige of its professionals and the diagnosis and treatment of highly complex pathologies. The Clínica Universidad de Navarra is a world-class hospital characterised by diagnostic speed and precision, multidisciplinary faculty, and acquisition of the latest technologies offering care across 48 different medical and surgical specialties.

The Clinic is ranked among the 100 best hospitals in the world, according to the World's Best Hospitals ranking, and among the 40 best oncology hospitals in the world according to the World's Best Specialized Hospitals ranking. For the eighth consecutive year, it has been named the private hospital with the best reputation in Spain (according to the Spanish healthcare reputation monitor ranking [MRS]).

For more information, please visit: https://www.unav.edu/en/research