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Ondine reports successful US Phase 2 trial data
Ondine reports successful US Phase 2 trial data.
About this update from Ondine Biomedical, Inc.
[{"type":"text","content":"\n \n \n 6 September 2022\n \n \n Ondine Biomedical Inc.\n \n \n (\"Ondine Biomedical\", \"Ondine\" or the \"Company\")\n \n \n \n Ondine reports successful US Phase 2 trial data\n \n \n \n \n Results show a single, 5-minute treatment of nasal photodisinfection significantly reduces Staphylococcus aureus,\n \n a major cause of surgical site infections, in pre-surgical patients\n \n \n ·\n 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<0.001).\n \n \n ·\n All of the 319 subjects received a single, 5-minute nasal photodisinfection treatment.\n \n \n ·\n \n S. aureus\n \n is the primary pathogen associated with surgical site infections (SSIs).[i]\n \n \n ·\n No reportable adverse events.\n \n \n 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\n nasal photodisinfection eliminated or significantly decreased S. aureus in 92% of carriers (P<0.001)\n immediately after treatment. There were no reportable adverse events or unexpected safety issues; t\n reatment was found to be safe and well tolerated.\n \n \n Carolyn Cross, CEO of Ondine Biomedical, commented:\n \n \n \"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.\"\n \n \n The single-centre, BENEFIT-APDT open-label study\n was carried out at HCA Healthcare's Memorial Health University Medical Center in Savannah, Georgia.\n 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.\n \n \n Jason Hickok, VP of Clinical & Medical Affairs commented:\n \n \n \"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...