RCS - Destiny Pharma PLC - FDA grants XF-73 Dermal QIPD for burn wound

Destiny PharmaAnnouncement

28/08/2024 08:15

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RNS Number : 8957B  Destiny Pharma PLC  28 August 2024

Destiny Pharma and
("Destiny Pharma" or "the Company")

Destiny Pharma Announces Qualified Infectious Disease Product Designation
Granted by US FDA for XF-73 Dermal Gel for Treatment of Burn Wound Infections

 

 

Brighton, United Kingdom - 28 August 2024 - Destiny Pharma, a clinical stage
biotechnology company focused on the development and commercialisation of
novel medicines to prevent and cure life threatening infections, is pleased to
announce that the US Food and Drug Administration (FDA) has granted Qualified
Infectious Disease Product (QIDP) designation to its XF-73 Dermal Gel for the
treatment or prevention of Staphylococcal (including MRSA) infections in burn
wounds.

 

Globally, (Greenhalgh (https://pubmed.ncbi.nlm.nih.gov/31189038/) et al
(https://pubmed.ncbi.nlm.nih.gov/31189038/) ., 2019
(https://pubmed.ncbi.nlm.nih.gov/31189038/) ) it is estimated that there are
approximately 9 million burn cases per year. Burn injuries contribute to over
250,000 fatalities (Moeini (https://pubmed.ncbi.nlm.nih.gov/32059889/) et al.
(https://pubmed.ncbi.nlm.nih.gov/32059889/) , 2020
(https://pubmed.ncbi.nlm.nih.gov/32059889/) ) with infections identified as
the cause of 61% of post-burn deaths (Gomez
(https://pubmed.ncbi.nlm.nih.gov/19317995/) et al
(https://pubmed.ncbi.nlm.nih.gov/19317995/) ., 2009
(https://pubmed.ncbi.nlm.nih.gov/19317995/) ). Recent reports show the
incidence of sepsis in burn patients ranges from 8% to 42% with related
mortality from 28-65% (Cabral (https://pubmed.ncbi.nlm.nih.gov/28454850/) et
al. (https://pubmed.ncbi.nlm.nih.gov/28454850/) , 2017
(https://pubmed.ncbi.nlm.nih.gov/28454850/) ). Staphylococcus aureus,
(including MRSA), is a common cause of post-burn infection; Alebachew
(https://pubmed.ncbi.nlm.nih.gov/23209356/) et al.
(https://pubmed.ncbi.nlm.nih.gov/23209356/) , 2012
(https://pubmed.ncbi.nlm.nih.gov/23209356/) reported that patients with burns
had a prevalence of S. aureus of 57.8%.

 

Under the US GAIN (Generating Antibiotic Incentives Now) Act, QIDP status
confers FDA priority review, eligibility for fast-track status, and an
additional five-year extension of US patent exclusivity when approval is
granted.

 

The FDA grants QIDP designations to drugs intended to treat serious or
life-threatening infections, caused by "qualified pathogens". These pathogens
include the hospital superbug, MRSA, which can cause devastating infection in
burn wounds, and can lead to life-threatening blood infection, (sepsis).

 

In the USA, XF-73 Dermal Gel development has been supported and funded by the
National Institute of Allergy and Infectious Diseases (NIAID), part of the
National Institutes of Health (NIH), with the recent successful completion of
a large-scale preclinical safety study,
https://www.destinypharma.com/2024/08/05/xf-73-prevents-bacterial-invasion-of-bloodstream/
(https://www.destinypharma.com/2024/08/05/xf-73-prevents-bacterial-invasion-of-bloodstream/)

 

The Company has previously been successful in gaining QIDP status for its
XF-73 Nasal medicine for the prevention of post-surgical staphylococcal
(including MRSA) infections.

 

Dr Bill Love, Chief Scientific Officer of Destiny Pharma, commented: "The QIDP
designation further underlines that medicines based on our breakthrough
antibiotic XF-73 are recognised as being urgently required to prevent and
treat life-threatening infections caused by hospital superbugs. We believe
this award will assist in earmarking XF-73 Dermal Gel as a potential
breakthrough medicine in the area of burn wound treatment."

 

Chris Tovey, Chief Executive Officer of Destiny Pharma, said: "XF‐73
Dermal's successful US FDA Qualifying Infectious Disease Product application
builds on the previously successful US FDA QIDP grant for XF-73 Nasal and
further reinforces the significant regulatory endorsement and recognition of
XF‐73 potential in addressing the challenges of antimicrobial resistance
along with highlighting the significant commercial potential."

 

The Company previously resolved to appoint Stephen Cork and Mark Smith of Cork
Gully LLP as Joint Administrators with effect from 21 August. The Joint
Administrators continue to work alongside the Board of Directors and staff to
progress discussions with potential investors, partners and interested parties
with a view to achieving an optimal outcome. Any additional parties who have
not already been in contact with the administration team are encouraged to
contact them via the contact details provided below.

 

For further information, please contact:

 

Cork Gully LLP

Stephen Cork, Joint Administrator

Mark Smith, Joint Administrator

+44 (0)20 7268 2150

destiny@corkgully.com

 

 

About Destiny Pharma

Destiny Pharma is an innovative, clinical-stage biotechnology company focused
on the development and commercialisation of novel medicines that can prevent
life-threatening infections. The Company's drug development pipeline includes
two late-stage assets XF-73 Nasal gel, a proprietary drug targeting the
prevention of post-surgical staphylococcal hospital infections including MRSA
and NTCD-M3, a microbiome-based biotherapeutic for the prevention of C.
difficile infection (CDI) recurrence which is the leading cause of hospital
acquired infection in the US.

 

For further information on the Company, please visit www.destinypharma.com
(http://www.destinypharma.com)

 

Forward looking statements

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