Surgical site infections are serious complications that occur in a significant number of patients post-surgery and can lead to severe life-long morbidities and can even be life-threatening. In addition to the impact on health, surgical sites infections cost approximately 10 Billion USD in the US alone.
Importantly, approximately 70-90% of post-surgical infections are caused by patients’ endogenous pathogens. S. aureus causes the majority of infections, a pathogen that resides in the nose of many of the general population.
Several studies have shown that nasal decolonisation is effective in reducing the risk of post-surgical site infections and consequently the recommendation for nasal decolonisation is captured in many international guidelines.
However, current Standard of Care (SoC) is suboptimal, as it requires a long treatment before surgery, and it is associated with bacterial resistance.
XF-73 Nasal gel is fast acting, requires very few applications and it has a very low propension to develop bacterial resistance. Thus, XF-73 Nasal gel, preventing post-surgical infections, has the potential to reduce hospitalization stay, accelerate recovery and rehabilitation and improve quality of life for patients undergoing vital surgeries.
A Phase 2b clinical study, which was a multi-centre, randomized, placebo-controlled study of XF-73 Nasal gel completed recruitment at the end of 2020 and top-line results were reported in Q1 2021, as planned.
The primary efficacy endpoint of the Phase 2b study was met, with an exceptionally high statistical significance and XF-73 Nasal gel reduced the mean nasal burden of Staphylococcus aureus in patients undergoing open heart surgery by 2.5 log (CFU/ml) in the 24 hours immediately before surgery, which equates to a 99.5% reduction in Staphylococcus aureus bacterial nasal carriage. These positive results were achieved with just four doses of XF-73 nasal gel in the 24 hours before incision and the start of surgery. Importantly the effect was maintained during surgery, considered the period when the risk for infections is the highest. The XF-73 Nasal gel also demonstrated an excellent safety profile, with no treatment related adverse events reported.
For more information on the trial results, please see here.
Destiny is now actively pursuing the further development of XF-73 and it has finalized its plans for the Phase 3 pivotal development programme in alignment with the feedback received by the FDA and EMA and based on input from several global key opinion experts.
The latest developments towards the Phase 3 programme design are summarised here.