TIDMDEST
RNS Number : 2039O
Destiny Pharma PLC
28 January 2019
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Destiny Pharma plc
("Destiny Pharma" or "the Company")
Second positive Phase 1 trial data from XF-73 skin irritation
study
Primary objective achieved by both XF-73 concentrations
Next step is key Phase 2b trial for XF-73 in the prevention of
post-surgical staphylococcal infections
Positive data also supports second clinical programme of XF-73
in dermal infection indications
Brighton, United Kingdom - 28 January 2019 - Destiny Pharma
(AIM: DEST), a clinical stage biotechnology company focused on the
development of novel antimicrobial drugs, which address the global
problem of antimicrobial resistance (AMR), today announces positive
data and the non-irritant classification for its XF-73 nasal gel
from the second Phase 1 safety clinical study examining the drug's
potential to cause irritation when administered topically.
The study, required under the Investigational New Drug (IND)
application opened in February 2018, achieved the primary objective
of a low cumulative irritancy score for both concentrations (0.05%
w/w and 0.2% w/w) with high statistical significance when compared
to a placebo of distilled water.
Neil Clark, Chief Executive of Destiny Pharma, commented:
"We are very pleased with the positive outcome in this second
Phase 1 study, which confirms the good safety profile of the XF-73
nasal gel formulation. We will now finalise plans for our key Phase
2b study testing XF-73 nasal gel as a novel therapy for the
prevention of post-surgical staphylococcal infections, including
MRSA. This is our lead indication targeting a billion-dollar US
market and there is a clear medical need for a new drug that is
safe, cost-effective and addresses the global medical concerns of
anti-microbial resistance.
These positive results also support the advancement of XF-73 in
Destiny Pharma's Phase 1 dermal infection programme and reinforce
the target product profile of XF-73 for both indications. XF-73
nasal gel is planned to move into Phase 2b clinical trials under
the US Food and Drug Administration (FDA) Qualified Infectious
Disease Product (QIDP) and Fast Track designation. This study will
examine the nasal antibacterial activity and safety of the 0.2% w/w
XF-73 nasal gel in over 150 patients at risk of post-surgical
infections. The study design is under review at the FDA and it is
planned to report data towards the end of 2019."
Further information on the Phase 1 clinical study
The Phase 1 clinical study, conducted in the US, enrolled 35
volunteers who received two XF-73 nasal gel clinical formulations
at anti-Staphylococcal concentrations (0.05% w/w and 0.2% w/w)
daily for 21 consecutive days on intact and abraded skin. Both
XF-73 concentrations yielded mean cumulative irritations scores
which were significantly lower than the mean cumulative irritancy
score of distilled water (p<0.0001).
The investigators did not report any XF-73 adverse events during
the study and no XF-73 was detected in blood samples taken,
confirming earlier dermal and nasal clinical trials which also
demonstrated no XF-73 appeared in the bloodstream, and reinforcing
its excellent safety profile. These are key advantages for XF-73
for nasal administration to eradicate bacteria Staphylococcus
aureus, including Methicillin-resistant Staphylococcus aureus
(MRSA), that are a common cause of potentially lethal post-surgical
infections.
For further information, please contact:
Destiny Pharma plc
Neil Clark, CEO
Shaun Claydon, CFO
pressoffice@destinypharma.com
+44 (0)1273 704 440
FTI Consulting
Simon Conway / Victoria Foster Mitchell
destinypharma@fticonsulting.com
+44 (0) 20 3727 1000
Cantor Fitzgerald Europe (Nominated Adviser and Joint
Broker)
Philip Davies / Will Goode, Corporate Finance
Andrew Keith, Healthcare Equity Sales
+44 (0)20 7894 7000
finnCap Ltd (Joint Broker)
Geoff Nash /Kate Bannatyne, Corporate Finance
Alice Lane, Corporate Broking
+44 (0)20 7220 0500
About XF-73
XF-73 is a synthetic anti-microbial active against all tested
Staphylococcus aureus strains, including drug resistant strains. By
acting via a cell-surface mechanism it affects the bacterial
membrane permeability and integrity, leading to cell death. XF-73
has already been through five successful Phase I/IIb clinical
trials showing rapid antibacterial action. In standard microbiology
studies XF drugs have demonstrated a unique no/low resistance
profile that means that XF compounds have the potential to deliver
novel drugs that are clearly differentiated from traditional
antibiotics where resistance limits their utility.
XF-73 is being studies for the prevention of post-surgical
staphylococcal infections. In the US, there are approximately 40
million surgeries per annum alone where the patient is at risk of a
post-surgical infection. However, within this large population
there are particular groups who are at an even higher risk of
infection due to the nature of their surgery or the procedures
and/or their specific hospital environment in which they are
treated. These higher risk surgical procedures include
cardiovascular, orthopaedic and other complex surgeries. Destiny
Pharma estimates that this totals approximately 14 million US
surgeries per year, with this figure set to rise within the context
of an ageing population.
About Destiny Pharma
Destiny Pharma is an established, clinical stage, innovative
biotechnology company focused on the development of novel medicines
that represent a new approach to the treatment of infectious
disease. These potential new medicines are being developed to
address the need for new drugs for the prevention and treatment of
life-threatening infections caused by antibiotic-resistant
bacteria, often referred to as "superbugs". Tackling anti-microbial
resistance has become a global imperative recognised by the WHO and
the United Nations, as well as the G7 and the G20 countries. For
further information, please visit https://www.destinypharma.com
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END
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