Destiny Pharma PLC Destiny Pharma opens IND ahead of XF-73 US trials (8564F)
26 February 2018 - 6:01PM
UK Regulatory
TIDMDEST
RNS Number : 8564F
Destiny Pharma PLC
26 February 2018
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Destiny Pharma plc
("Destiny Pharma" or the "Company")
Destiny Pharma opens IND for its novel anti-infective drug XF-73
ahead of commencing US clinical trials
Brighton, United Kingdom - 26 February 2018 - Destiny Pharma
(AIM: DEST), a clinical stage biotechnology company focused on the
development of novel anti-microbial drugs, which address the global
problem of anti-microbial resistance (AMR), today announces that
the US Food and Drug Administration (FDA) has accepted an
Investigational New Drug application (IND) for the Company's lead
clinical drug candidate, XF-73. This is being developed for the
prevention of post-surgical staphylococcal infections such as
Methicillin Resistant Staphylococcus aureus (MRSA).
Neil Clark, Chief Executive Officer of Destiny Pharma,
commented:
"Destiny Pharma is one of only a small number of UK biotech
companies which have antibacterial drugs at the clinical stage of
development. We are pleased to open the IND and are looking forward
to starting the clinical programme and reporting the Phase 2 data
in 2019. The US is the largest potential market for this drug
candidate and XF-73 could be the first drug approved for the US
FDA's newly defined indication of "prevention of post-surgical
staphylococcal infection". We look forward to continuing to advance
XF-73 through clinical development."
XF-73 has been developed from Destiny Pharma's novel,
antimicrobial "XF" drug platform. Unlike most antibiotics, XF drugs
have not been seen to generate bacterial resistance in
industry-standard microbiology tests to date and therefore have
significant potential to address the global threat of AMR. XF-73
has been shown to kill bacteria very rapidly and therefore may be
an effective new treatment in the reduction of bacterial infections
in hospital patients, including those caused by MRSA. XF-73 is
administered topically as a nasal gel whereby it reduces the nasal
carriage of the bacteria Staphylococcus aureus which is the source
of many post-surgical bacterial infections. Approximately a third
of all patients across the world have this nasal carriage as they
enter surgery and it is has the potential to be a very valuable
market due to the millions of surgical procedures carried out each
year.
As stated at the IPO in September 2017, under the new IND,
Destiny Pharma will now complete certain standard Phase 1 studies
in the US and will also be able to finalise the study design of the
Phase 2 clinical trial. This Phase 2 study will evaluate the nasal
anti-staphylococcal efficacy and clinical safety of XF-73 compared
to placebo in pre-surgical patients at risk of infection. The study
design will be closely related to the successful 2016 clinical
trial, which was funded by the National Institute of Allergy and
Infectious Disease (part of the US National Institute of Health)
and demonstrated the clinical efficacy of XF-73 versus placebo in
reducing nasal Staphylococcus aureus carriage in healthy
volunteers.
Following a review of clinical trial data, XF-73 was awarded
Qualifying Infectious Disease Product (QIDP) status in October 2015
by the US FDA. Within the QIDP award, the US FDA also confirmed a
new US disease indication for XF-73; namely the 'Prevention of
post-surgical staphylococcal infections'. This represents a new US
market for which no existing product is approved. QIDP status
identifies XF-73 as a drug that is intended to treat serious or
life-threatening infections, including those caused by antibiotic
resistant pathogens. Destiny estimates the potential global market
for XF-73 to be over one billion US dollars.
MRSA is one of the most prominent superbugs and a major cause of
hospital associated infection and featured in the WHO's 'most
dangerous' list of superbugs published in 2017. The WHO followed US
and European guidelines in 2016 by recommending the screening and
decolonisation of MRSA and all strains of Staphylococcus aureus in
pre-surgical patients undergoing high risk surgeries in a step
designed to help prevent such infections.
For further information, please contact:
Destiny Pharma plc
Neil Clark, CEO
Simon Sacerdoti, 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 Broker)
Philip Davies / Will Goode, Corporate Finance
+44 (0)20 7894 7000
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.
XF-73 is indicated 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
This information is provided by RNS
The company news service from the London Stock Exchange
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