RCS - Destiny Pharma PLC - FDA/CDC highlight need for infection preventions

Destiny PharmaAnnouncement

07/12/2022 07:00

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RNS Number : 7826I  Destiny Pharma PLC  07 December 2022

Destiny Pharma plc

("Destiny Pharma" or "the Company")

 

US FDA/CDC workshop highlights the need for new approaches

for the prevention of hospital-acquired infections

 

·    Particular support for decolonisation of pathogens which is the
approach taken by its XF-73 Nasal programme

 

 

Brighton, United Kingdom, 07 December 2022 - Destiny Pharma plc (AIM: DEST), a
clinical stage innovative biotechnology company focused on the development of
novel medicines that can prevent life-threatening infections, today reports on
the publication of findings from the US Food and Drug Administration (FDA) and
US Centers for Disease Control (CDC) public workshop on considerations for the
prevention of hospital-acquired infection, which can be found here:
https://info.rescueagency.com/en-us/drug-development-consideration-virtual-public-workshop-cdc-fda
(https://info.rescueagency.com/en-us/drug-development-consideration-virtual-public-workshop-cdc-fda)

This workshop brought together representatives from key US government
regulators as well as pharmaceutical companies, infection control physicians
and patient advocates to discuss the growing issue of hospital-acquired
infections in the US and the clear need for new interventions that could
address this issue.

 

Destiny Pharma attended the discussion and was very pleased that the meeting
reinforced the Company's conviction in infection prevention as a key component
in the management of serious hospital-acquired infections. The text below is
extracted from the published notes of the meeting and provides clear support
for the Company's approach with XF-73 Nasal and NTCD-M3.

 

Dr Michael Craig, (Director of Antimicrobial Resistance) at the US CDC stated:

 

·    "Decolonization is something that is very important to us at CDC and
something that we think really holds a lot of potential in terms of saving
lives and importantly addressing the challenges of antimicrobial resistance
that we face, not only in the United States but around the world, and so from
our perspective, and I think the bottom line for us, is focusing on drugs that
could potentially prevent transmission of deadly pathogens, especially those
that are antimicrobial resistant."

 

·    "We need to have prevention modalities that can really stop the
spread of infectious diseases and deadly pathogens and so what we would like
is additional potential drugs that could be brought to bear so that we could
further reduce and maybe even eliminate the risk of that colonization becoming
an infection in an individual or that colonization spreading to others and
being transmitted in sites like nursing homes or ICUs."

 

Dr John Jernigan, (Director of HAI Prevention Research and Evaluation, CDC)
stated:

 

·    "Decolonization, by its strict definition, refers to complete
elimination of the colonizing microorganism, but for the purpose of our
conversations today, I invite you to think about decolonization in a slightly
broader context to include pathogen burden reduction or reduction in microbial
load of the colonizing pathogen."

 

·    "Reducing colonization may be a potent antibiotic resistance
prevention strategy. Furthermore, because of their potential for indirect
benefit, efforts to produce and improve and approve novel safe and effective
decolonizing agents are likely to prevent substantially more harm from
antibiotic resistance than can be prevented if we focus drug development
solely on drugs that treat infections."

 

Destiny Pharma's infection prevention programmes

 

Destiny Pharma has two infection prevention clinical programmes that have
delivered excellent Phase 2 data and are now heading towards their final Phase
3 clinical studies.

XF-73

 

XF-73 Nasal is a novel drug being developed by Destiny Pharma to eradicate S.
aureus (SA), including MRSA from the nose before surgery to prevent
post-surgical infection.  The use of this simple nasal gel before surgery
will reduce the need for antibiotic decolonization and by reducing
post-surgical infection it will also decrease the use of post-surgical
antibiotics to treat infection. There are some 20 million high-risk surgeries
and five million intensive care unit (ICU) patient admissions per year in the
US alone, a third of whom carry SA in the nose, who could benefit.

NTCD-M3

 

NTCD-M3 is a single strain biotherapeutic being developed by Destiny Pharma
for the prevention of the recurrence of infections caused by toxic strains of
the gut bacteria Clostridioides difficile (C. diff). These infections can
cause significant inflammation and damage to the gut leading to an estimated
29,000 deaths annually in the US alone (a number comparable to the yearly
deaths caused by prostate cancer).

 

Dr. Yuri Martina, CMO of Destiny Pharma, responded to the findings: "This
workshop marks an important starting point for the FDA, CDC and the
pharmaceutical industry to exchange ideas and thoughts which look at
substantially increasing the development of new drugs addressing infection
prevention. A shift in thinking is evident and it has been expressed by many
of the speakers during the workshop. This encouragement from the FDA and CDC
for new infection prevention products for the US market provides a supportive
backdrop for Destiny Pharma's approach, with its two late clinical stage
products targeting infection prevention (XF-73 and NTCD-M3) whilst addressing
the threat of antimicrobial resistance (AMR). Using the words of Dr. Craig -
'Prevention ultimately saves lives'."

 

For further information, please contact:

Destiny Pharma plc (https://www.destinypharma.com/)

Neil Clark, CEO

Shaun Claydon, CFO

pressoffice@destinypharma.com (mailto:pressoffice@destinypharma.com)

+44 (0)1273 704 440

 

Optimum Strategic Communications (https://www.optimumcomms.com/)

Mary Clark, Nick Bastin, Manel Mateus, Eleanor Cooper

DestinyPharma@optimumcomms.com (mailto:DestinyPharma@optimumcomms.com)

+44 20 3922 0891

 

finnCap Ltd (Nominated Advisor and Joint Broker)

Geoff Nash / George Dollemore, Corporate Finance

Alice Lane / Nigel Birks / Harriet Ward, Corporate Broking

+44 (0) 207 220 0500

 

Shore Capital (Joint Broker)

Daniel Bush / James Thomas / Lucy Bowden

+44 (0) 207 408 4090

 

MC Associates AG

Anne Hennecke / Andreas Burckhardt

+49-211-529252-0

 

Stern IR - US

Janhavi Mohite

+1-212-362-1200

Janhavi.Mohite@sternir.com (mailto:Janhavi.Mohite@sternir.com)

 

About Destiny Pharma

 

Destiny Pharma is a clinical stage, innovative biotechnology company focused
on the development of novel medicines that can prevent life-threatening
infections. Its pipeline has novel microbiome-based biotherapeutics and XF
drug clinical assets including NTCD-M3, a Phase 3 ready treatment for the
prevention of C. difficile infection (CDI) recurrence which is the leading
cause of hospital acquired infection in the US and also XF-73 nasal gel, which
has recently completed a positive Phase 2b clinical trial targeting the
prevention of post-surgical staphylococcal hospital infections including MRSA.
It is also co-developing SPOR-COVTM, a novel, biotherapeutic product for the
prevention of COVID-19 and other viral respiratory infections and has earlier
grant funded XF drug research projects.

 

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

 

 

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