Ondine Biomedical, a Canadian company specializing in life sciences, has declared that it is stepping up the final preparations to kick off its key US Phase 3 clinical trial in Q4 2024. This acceleration comes in the wake of a successful fundraiser that totalled Cdn $16 million (US $11m), attracting substantial support from existing institutional shareholders and a roster of new shareholders, among which is M&G Investment Management Limited. Additionally, conversations are in progress with a leading American healthcare group in regard to a potential investment of approximately Cdn $5.5 million (US $4m).
Ondine Biomedical is spearheading the development of light-activated antimicrobials, economical solutions capable of exterminating all categories of pathogens – viruses, bacteria, and fungi – within minutes without fostering the development of pathogenic resistance. Presently, the company is emphasizing on nasal decolonization prior to surgery to curtail hospital-associated infections. This endeavour utilizes its proven Steriwave® technology, a unique, painless infection control therapy.
Exceptional benefits have been observed in hospitals employing Ondine’s Steriwave technology, with marked dwindling in surgical site infection rates, patient readmissions, length of stay, as well as antibiotic usage. Ondine’s Steriwave technology is in active use in numerous hospitals across Canada and several NHS hospitals in the UK, such as Mid Yorks, Leeds Teaching Hospitals, and King’s College London. The company’s future plans include extending its product reach beyond North America through its newly inked distribution partnership with Mölnlycke Health Care.
Celebrating the successful funding, Carolyn Cross, Ondine’s CEO, has expressed her excitement over moving forward with the key Phase 3 clinical trial in the USA for FDA approval. She also mentions that the capital procured will bolster their stride towards treating the first patient in December 2024. She credits strong interest in the technology as a critical driver for the successful fundraiser, attributing it to the innovative light-activated antimicrobial technology, especially set against the backdrop of an escalating death toll due to antimicrobial resistance (AMR).
For the impending Phase 3 trial, Ondine is collaborating closely with HCA Healthcare, the premier healthcare provider in the United States. The study comprising 5,000 patients will be performed at 14 HCA hospital sites. The trial aims to compare standard-of-care infection prevention practices with Ondine’s nasal photodisinfection (marketed as Steriwave® outside the US). The recruitment of the first patient is targeted for the end of 2024, and the final patient is expected mid-2025, with initial data readouts predicted for Autumn 2025.