Destiny Pharma has disclosed data showing a reduction in its drug Staphylococcus aureus in the nasal passages of preoperative cardiac surgery patients.
Destiny Pharma is a clinical-stage biotechnology company focused on developing new drugs to prevent life-threatening infections. The data is published in a journal Hospital Infection Control & Epidemiology.
This paper was published by Julie Mangino (Professor Emeritus, Division of Infectious Diseases, at The Ohio State University, USA) who is the lead author and member of the data safety monitoring committee for clinical trials.
Paper titled, ‘Exeporfinium Chloride (XF-73) Nose Gel Dosed 24 Hours Before Surgery Significantly Reduced Staphylococcus aureus Nasal Carriage in Cardiac Surgery Patients: Safety and Efficacy Results from a Phase 2 Randomized Placebo-Controlled Study.’
Destiny Pharma says study main end point reached: XF-73 shows 99.5% reduction S aureus bacterial nasal carriers, which is a clinically relevant reduction in nasal carriers.
Data showed 83.7% of patients treated with XF-73 nasal gel either completely decolonized nasal S. aureus or showed ≥99% reduction one hour before surgery compared to only 25% in the placebo group. Positive results were achieved with three doses of XF-73 nasal gel within 24 hours before the surgical incision.
Decolonization of XF-73 from S aureus maintained during the perioperative period, which is considered when the risk of infection is highest.
Mangino said: “XF-73 provides a fast effective and safe new agent to complement the armamentarium of skin/whole body decolonization to prevent Staphylococcus aureus surgical site infection (SSI). Prevention is key to avoiding SSI morbidity and mortality.”
Destiny Pharma says the gel is a game changer
Bill Love, Destiny Pharma’s chief scientific officer, said: “This is certainly the most important paper we have published on XF-73 nose gel. Peer-reviewed and published in a leading US infection control journal, means that the extraordinary ability of our products to quickly and effectively decolonize patients before surgery, will be shared and made available to those in the hospital infection control field. XF-73 nasal gel is a potential game changer in the fight to reduce the risk of postoperative infections from hospital superbugs.
Destiny Pharma recently discussed with regulators the options for a late phase 3 clinical development stage to gain approval for its XF-73 nasal gel product in the US and Europe.
Last year, the FDA clarified its phase 3 and US registration pathways for gels for the prevention of postoperative staphylococcal infections. The company is also starting an oral mucositis trial using XF-73.
The company added that it is actively seeking partners for the XF-73 nose program.