Destiny Pharma has revealed data showing its drug reduced Staphylococcus aureus in the nasal passage of pre-op cardiac surgery patients.
Destiny Pharma is a clinical stage biotechnology company focused on the development of novel medicines to prevent life threatening infections. The data was published in the journal Infection Control & Hospital Epidemiology.
The paper was published by Julie Mangino (Professor Emeritus, Division of Infectious Diseases, at The Ohio State University, U.S.) who is the lead author and a member of the data safety monitoring committee for the clinical trial.
The paper is entitled, ‘Exeporfinium Chloride (XF-73) Nasal Gel Dosed over 24 Hours Prior to Surgery Significantly Reduced Staphylococcus aureus Nasal Carriage in Cardiac Surgery Patients: Safety and Efficacy Results from a Randomized Placebo-Controlled Phase 2 Study.’
Destiny Pharma said the study primary endpoint was achieved: XF-73 showed a 99.5% reduction in S. aureus bacterial nasal carriage, which is a clinically relevant reduction in nasal carriage.
Data showed 83.7% of XF-73 nasal gel treated patients were completely decolonized of nasal S. aureus or exhibited a ≥99% reduction one hour ahead of surgery compared to just 25% in the placebo group. The positive results were achieved with three doses of XF-73 nasal gel in the 24 hours before the surgical incision.
XF-73 decolonization of S. aureus was maintained throughout the perioperative period, which is considered to be when the risk of infection is highest.
Mangino said: “XF-73 provides a rapidly effective and safe new agent to complement the armamentarium of skin/whole body decolonization to prevent Staphylococcus aureus surgical site infections (SSI). Prevention is primary to avoid the morbidity and mortality of SSIs.”
Destiny Pharma says gel is a game changer
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 U.S. infection control journal, will mean that the exceptional ability of our product to decolonize 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 discussed with regulators options for the final phase 3 clinical development stage to obtain approval for the XF-73 nasal gel product in the U.S. and Europe.
Last year, The FDA clarified the phase 3 and U.S. registration pathway for the gel for the prevention of post-surgical staphylococcal infections. The company also started an oral mucositis trial utilizing XF-73.
The company added it is actively seeking partners for the XF-73 nasal program.