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.”
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