RCS - Destiny Pharma PLC - US Center for Disease Control review paper

Destiny PharmaAnnouncement

25/01/2023 07:00

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RNS Number : 7503N  Destiny Pharma PLC  25 January 2023

Destiny Pharma plc

("Destiny Pharma" or the "Company")

 

 US Center for Disease Control (CDC) and two major medical journals cite the
importance of decolonization in preventing surgical site infections

 

Brighton, United Kingdom - 25 January 2023 - Destiny Pharma plc (AIM: DEST), a
clinical stage biotechnology company focused on the development of novel
products to prevent life-threatening infections, notes an increased focus on
the importance of infection prevention by the Center for Disease Control
("CDC"), Food and Drug Administration ("FDA"), and the medical community in
general, following a series of announcements and two publications in leading
medical journals in recent weeks.

 

Destiny is developing its novel XF-73 Nasal gel for the prevention of
post-surgical infections. XF-73 is the lead drug candidate developed from
Destiny Pharma's XF platform and it is initially being developed for the
prevention of post-surgical staphylococcal infections, such as
methicillin-resistant Staphylococcus aureus (MRSA), which can cause
significant complications and increased healthcare costs in the hospital
setting.

 

Dr. Yuri Martina, Chief Medical Officer of Destiny Pharma, said: "The Centre
for Disease Control's announcement clearly recognizes the need for new and
effective decolonization agents and their importance for public health. They
have made a clear call to simplify the pathway to regulatory approval and
suggested the need for establishing new surrogate endpoints. Destiny Pharma
views this as a very encouraging shift in the agency's thinking that could be
very supportive to our clinical  development of XF-73 Nasal.

 

"Furthermore, it is important to note the two new papers in such respected
journals as the Journal of the American Medical Association and the New
England Journal of Medicine, which have both underlined the importance of
decolonization in preventing post-surgical infections and complications. Both
papers have also elaborated on the substantial impact of post-surgical
infections for patients and the potential for long-term debilitation and
life-threatening consequences. At Destiny Pharma, we are committed to
progressing the Phase 3 clinical development of our XF-73 Nasal gel targeting
nasal decolonization and delivering a new product to prevent post-surgical
infections and the resulting complications for patients in hospitals around
the world."

 

CDC announcement underlines the need for new decolonization agents

 

On 28th December 2022, the CDC released a Broad Agency Announcement, following
up on a CDC-FDA workshop held in August 2022, that clearly underlines the need
for new decolonization agents, which have largely been missing in recent
years, leading to an important gap in the public health portfolio of infection
prevention. The Company believes this adds further support to its Phase 3
clinical strategy for XF-73 Nasal gel targeting nasal decolonization prior to
surgery and indicates that regulators are increasingly aware of the importance
and value of decolonization to help prevent infections. Prevention is better
than cure.

 

Two major review publications supporting decolonization published

 

In January 2023, two important review papers on the key role of decolonization
were published, by The Journal of the American Medical Association ("JAMA")
and The New England Journal of Medicine ("NEJM").

 

The Journal of the American Medical Association

The JAMA review was authored by Dr. Deverick J. Anderson and colleagues at
Duke Center for Antimicrobial Stewardship and Infection Prevention of the Duke
University School of Medicine. In this review, the authors underline the
following key points:

 

-      A large number of patients experience post-surgical infections,
often with severe morbidity and complications.

-      Surgical site infections are among the most prevalent health
care-acquired infections and result in significant costs, potentially reaching
US$10 billion per year.

-      Approximately 70-95% of surgical sites infections are caused by
the patient's endogenous flora. Among these, S. aureus is the most common
cause of infection.

-      Several risk factors are associated with surgical site infection.
Some can be modified, but others cannot be impacted.

-      Nasal decolonization has shown a substantial reduction in surgical
site infections and especially in high-risk surgeries like orthopaedic and
cardiothoracic procedures.

-      Nasal decolonization should be achieved as close to surgery as
possible, as this is the time when it is most effective.

-      The current standard of care requires a fairly long procedure and
consequently a significant amount of coordination.

 

The New England Journal of Medicine

The NEJM review was authored by Dr. Robin Patel from the Division of Clinical
Microbiology, Department of Medicine at the Mayo Clinic, and focuses on the
topic of periprosthetic joint infection (PJI). In this paper, Dr. Patel
discusses the importance of prevention to reduce the burden of PJI and its
impact on the healthcare system and the patients. Importantly, Dr. Patel
underlines the following critical points:

 

-      PJI is a serious complication of orthopaedic surgery with an
average frequency of 2.3%.

-      PJI complication is costly and burdensome for the patient and the
healthcare system. The author estimates additional cost of US$391,000 for a
PJI of the hip.

-      PJI is associated with extended hospital stay, less-than-ideal
success rates, decreased quality of life, pain, and high mortality.

-      Reducing risks factors is not always possible and some risk
factors cannot be influenced.

-      A major impact on reducing PJI incidence can be achieved by
implementing proper decolonization protocols.

 

 

For further information, please contact:

 

Destiny Pharma plc
Neil Clark, CEO

Shaun Claydon, CFO

+44 (0)1273 704 440
pressoffice@destinypharma.com
(https://www.destinypharma.com/2022/05/26/26-may-2022-destiny-pharma-plc-board-changes/blank)

 

Optimum Strategic Communications  (https://www.optimumcomms.com/)
Mary Clark / Nick Bastin / Eleanor Cooper

+44 (0) 203 922 0891
DestinyPharma@optimumcomms.com
(https://www.destinypharma.com/2022/05/26/26-may-2022-destiny-pharma-plc-board-changes/blank)

 

finnCap Ltd (Nominated Advisor and Joint Broker)
Geoff Nash / George Dollemore, Corporate Finance

Alice Lane / Nigel Birks / Harriet Ward, ECM

+44 (0) 207 220 0500

Shore Capital (Joint Broker)

Daniel Bush / James Thomas / Lucy Bowden

+44 (0) 207 408 4090

MC Services AG
Anne Hennecke / Andreas Burckhardt

+49-211-529252-12

Stern IR - US

Janhavi Mohite

+1-212-362-1200

Janhavi.Mohite@sternir.com (about%3Ablank)

 

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-COV(TM), 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 on the company, please visit www.destinypharma.com
(https://www.destinypharma.com)

 

Notes to editors

 

·      On 28(th) December 2022, CDC released a Broad Agency Announcement
calling for alternative clinical outcomes and/or surrogate endpoints to
facilitate clinical trials for decolonization drugs

·    On the 17(th) of January 2023, a paper published in The Journal of
American Medical Association (JAMA) underlines the importance of
decolonization and nasal decolonization from S. aureus to prevent
post-surgical site infection

·    On the 19(th) of January 2023, the New England Medical Journal (NEJM)
published a paper discussing the issue of periprosthetic joint infection
(PJI), its outcomes and implications and its prevention through the reduction
of risk factors and proper decolonization protocols

 

 

 

Forward looking statements

 

Certain information contained in this announcement, including any information
as to the Group's strategy, plans or future financial or operating
performance, constitutes "forward-looking statements". These forward-looking
statements may be identified by the use of forward-looking terminology,
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announcement and include statements regarding the intentions, beliefs or
current expectations of the Directors concerning, among other things, the
Group's results of operations, financial condition, prospects, growth,
strategies and the industries in which the Group operates. The directors of
the company believe that the expectations reflected in these statements are
reasonable but may be affected by a number of variables which could cause
actual results or trends to differ materially. Each forward-looking statement
speaks only as of the date of the particular statement. By their nature,
forward-looking statements involve risks and uncertainties because they relate
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operations, financial condition and the development of the industries in which
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