Destiny Pharma PLC (AIM:DEST) has unveiled what it described as “strong data” from its recent Phase 2b clinical trial of its XF-73 nasal gel.
The additional data showed that cardiac surgery patients receiving XF-73 nasal gel exhibited a valuable, sustained nasal reduction of Staphylococcus aureus (commonly referred to as “staph) bacteria after wound closure.
The results follow March’s data release, which showed the study had met its primary endpoint, demonstrating a highly significant reduction of 2.5 log (>99%) in nasal Staphylococcus aureus immediately before surgery compared to placebo (p<0.0001) after just 24 hours of XF-73 nasal gel dosing. The placebo-treated patients showed only a 0.4 log reduction in bacterial load immediately before surgery.
Analysis of the data released today shows the bacterial reductions in XF-73 treated patients were “highly statistically significant” over placebo at the one hour and two days post-surgery timepoints; as a result of the antibiotic dosing used as standard of care, the six-day time point reduction in the placebo group was equivalent to the XF-73 arm, which was expected.
Destiny said the sustained nasal microbiological effect in the period of greatest risk (pre-surgery to wound healing) of XF-73 in patients is a desirable attribute for the reduction in the risk of acquiring a post-surgical, staphylococcal infection.
“Today's new data demonstrates that XF-73 nasal gel has the potential to keep patients at a significantly low S. aureus nasal burden during the period of highest infection risk which runs from 1 hour prior to incision, during surgery itself, to the start of wound healing and out to at least 6 days post-surgery,” Destiny said.
“We are having discussions with regulators in US and Europe to enable us to design the required Phase 3 clinical study and will announce further updates later in 2021,” revealed Neil Clark, the chief executive officer of Destiny.
“XF-73 has great potential to provide a safe, fast-acting medicine that kills S. aureus in the nose prior to surgery thereby reducing patient infections whilst not generating bacterial resistance. There is a clear clinical need for such a new medicine that helps prevent post-surgical infections and there is a significant commercial opportunity,” Clark maintained.
Professor Richard Proctor, a member of Destiny’s scientific advisory board, said the new clinical data released today is an important observation for several reasons.
“First, nasal S. aureus burden directly correlates with the incidence of post-surgical wound infections. Second, reduction in S. aureus nasal colonisation is associated with decreased numbers of all staphylococcal infections," he explained.