Destiny Pharma, a UK-based clinical stage biotechnology company focused on the development of novel medicines to prevent life threatening infections, has published landmark XF-73 clinical data in the US peer reviewed journal Infection Control & Hospital Epidemiology.
The paper was published by Dr. Julie Mangino (Professor Emeritus, Division of Infectious Diseases, at The Ohio State University, US) who is the lead author and a member of the Data Safety Monitoring Committee for the clinical trial.
The study achieved its primary endpoint: XF-73 showed a 99.5% reduction in S. aureus bacterial nasal carriage, which is a clinically relevant reduction in nasal carriage. This equates to a reduced nasal burden of S. aureus in patients undergoing open heart surgery by 2.5 log (CFU/ml) in the 24 hours immediately before surgery, a highly statistically significant result, (p<0.0001).
83.7% of XF-73 nasal gel treated patients were completely decolonised of nasal S. aureus or exhibited a ≥99% reduction one hour ahead of surgery compared to just 25% in the placebo group.
These positive results were achieved with three doses of XF-73 nasal gel in the 24 hours before the surgical incision.
XF-73 decolonisation of S. aureus was maintained throughout the perioperative period, which is considered to be when the risk of infection is highest.
Dr Julie Mangino, Professor of Infectious Disease at The Ohio State University, said: “XF-73 provides a rapidly effective and safe new agent to complement the armamentarium of skin/whole body decolonisation to prevent Staphylococcus aureus surgical site infections (SSI). Prevention is primary to avoid the morbidity and mortality of SSIs.”
Dr Bill Love, Chief Scientific Officer of Destiny Pharma, said: “This is certainly the most important paper that we have published on XF-73 nasal gel. Peer-reviewed and published in a leading US infection control journal, will mean that the exceptional ability of our product to decolonise patients rapidly and effectively before surgery, will be shared and available to those in the field of hospital infection control. XF-73 nasal gel is a potential game changer in the fight to reduce the risk of post-surgical infections from hospital superbugs.”
Destiny Pharma has recently completed detailed interactions with the regulators and identified options for the final Phase III clinical development stage to obtain approval for the XF-73 nasal gel product in the US and Europe. The company is actively seeking partners for the XF-73 nasal programme.