Ondine reports success in MRSA clinical trial
Ondine Biomedical reported full results from its phase two ‘BENEFIT-PDT’ clinical trial on Friday, which met its primary endpoint of bacterial load reduction after nasal photodisinfection.
The AIM-traded firm explained that the nostrils are considered a primary reservoir of pathogens, including staphylococcus aureus and multidrug-resistant S. aureus (MRSA), which is 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.
The secondary endpoint was also met, demonstrating a “far lower” surgical site infection rate among treated patients, versus the United States historical national average rate at 0.6% versus 3%.
There were no treatment-related reportable adverse events, with treatment found to be safe and well tolerated.
“This study demonstrates that Ondine's photodisinfection technology robustly reduces nasal S. aureus colonisation in presurgical patients,” said Dr Simon Sinclair, non-executive director at Ondine and former medical director of Johnson & Johnson Medical Devices EMEA.
“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.”
At 1047 GMT, shares in Ondine Biomedical were down 3.014% at 24p.
Reporting by Josh White for Sharecast.com.