¡¾Destiny Pharma-Product XF-73¡¿Secondary Endpoint Analysis from Phase 2b Trial
2021-08-02 16:47

2nd August, 2021 - Destiny Pharma issued an announcement, which is summarized as follows: 

Update on secondary endpoint analysis from recent positive Phase 2b trial

Cardiac surgery patients receiving XF-73 nasal gel exhibited a valuable, sustained nasal reduction of Staphylococcus aureus

Destiny Pharma today announces additional, strong data from its recent Phase 2b clinical trial. The additional data shows that XF-73 dosed patients can also benefit from a sustained bacterial reduction at the three post-surgical sample time points after wound closure of 1 hour, 2 and 6 days demonstrating 2.5 log, 2.4 log and 2.8 log reductions, respectively, and sustaining the drop of over 99% in S. aureus nasal burden. The placebo treated patients reported 0.4 log, 1.5 log and 2.5 log reductions at the same time points. The bacterial reductions in XF-73 treated patients were shown to be highly statistically significant over placebo at the 1 hour and 2 days post-surgery timepoints (p<0.0001 and p<0.003, respectively). As a result of the antibiotic dosing used as standard of care, the 6-day time point reduction in the placebo group were equivalent to the XF-73 arm which was expected as it is known that pre- and post-surgical systemic anti-staphylococcal antibiotic dosing elicits a slow, gradual reduction in nasal bacterial carriage.

This 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.

Neil Clark, CEO of Destiny Pharma, said: ¡°We are very pleased to announce this additional, positive data from the successful Phase 2b study of XF-73 as a novel drug to reduce the incidence of post-surgical infections such as MRSA. 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. 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.¡±

Scientific Advisory Board member, Professor Richard Proctor, said: ¡°This new clinical data from the Phase 2b trial wherein XF-73 produces a sustained reduction in nasal burden of S. aureus out to at least 6 days 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 colonization is associated with decreased numbers of all staphylococcal infections.¡±

Original website Link:

https://www.destinypharma.com/2021/08/02/02-august-2021-secondary-endpoint-analysis-from-phase-2b-trial/