REG - Destiny Pharma PLC - Positive update from US FDA on XF-73 Phase 3

Destiny PharmaAnnouncement

19/07/2022 07:00

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RNS Number : 8754S  Destiny Pharma PLC  19 July 2022

Destiny Pharma plc

("Destiny Pharma" or the "Company")

 

Destiny Pharma announces positive update from US FDA on XF-73 Phase 3
development plans

 

·      FDA clarifies Phase 3 and US registration pathway for XF-73 Nasal
gel for the prevention of post-surgical staphylococcal infections

·      Feedback enables the Phase 3 study design to be simplified and is
expected to shorten the overall clinical development timelines

 

Brighton, United Kingdom - 19th July 2022 - Destiny Pharma plc (AIM: DEST), a
clinical stage biotechnology company focused on the development of novel
products to prevent life-threatening infections, is pleased to announce that
it has received positive feedback from the US Food and Drug
Administration (FDA) on the proposed XF-73 Nasal US Phase 3 study design and
development programme.

 

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.

 

The key points from the FDA's feedback are:

 

·    The FDA agreed to the proposed Phase 3 design comparing XF-73 Nasal
gel to placebo on top of standard of care for the prevention of post-surgical
staphylococcal infections following certain breast surgery operations. This
type of surgery is being proposed as patients can experience a relatively high
infection rate following the current standard of care and there is a clear
unmet medical need.

·     The FDA is open to the collection of microbiological data during the
proposed Phase 3 study that could lead to the development of a surrogate
marker for clinical efficacy in other types of surgery.

·   Based on the favourable safety profile from the clinical development
programme so far, the FDA has confirmed that no specialised nasal examinations
are needed in the Phase 3 study. In line with the above, the FDA has also
removed the previous requirement to clinically evaluate skin sensitisation.

·     The regulatory feedback will enable Destiny Pharma to simplify the
Phase 3 study design and is expected to shorten the overall clinical
development programme in the US.

 

Based on the FDA's feedback, Destiny Pharma is now focused on finalising the
US study design and biostatistical analysis to clarify the final patient
numbers required and the related costings and timeline. The Company is also
exploring the possibility of designing a global Phase 3 clinical programme,
likely to consist of two studies, that meets the requirements of both the FDA
and European Medicines Agency (EMA) and a further update on this will be made
in due course.

 

The breast surgery patient population for the Phase 3 clinical trial has been
chosen to meet FDA requirements for a "placebo plus standard of care"
comparator with the primary endpoint being statistically significant evidence
that the use of XF-73 Nasal gel results in fewer post-surgical site
infections. The Company is confident that positive Phase 3 results will mean
that XF-73 Nasal gel will be used in breast surgery and more widely in the
many other surgical procedures where decolonisation is recommended. It is
estimated that approximately one third of the global population are carriers
of S. aureus, typically in the nose, putting them at a significantly higher
risk of acquiring a post-surgical infection.  Consequently, nasal
decolonisation is recommended across many high-risk surgeries which is a very
large patient population in the US and across the world meaning that the XF-73
Nasal gel is targeting a multi-billion $ market opportunity in the hospital
setting.  The need for better anti-microbial treatments such as XF-73 Nasal
gel, is underlined by XF-73 having previously been awarded FDA Qualifying
Infectious Disease Product (QIDP) and Fast Track status.

 

In the US and worldwide, there are no approved nasal drugs for the prevention
of post-surgical staphylococcal infections. The generic antibiotic mupirocin
has been used to treat patients who carry the bacteria prior to surgery to
reduce the risk of infection. However, the use of existing preventative
treatments is severely limited by the existence, and fear of generating drug
resistant bacteria. In contrast, XF-73 Nasal gel has been shown not to
generate drug-resistant bacteria and thereby reduces the threat posed by
Anti-Microbial Resistance (AMR). Furthermore, this superior bacterial
resistance profile makes it ideally suited for widespread use in the
prevention of post-surgical infections.

 

Dr. Yuri Martina, Chief Medical Officer of Destiny Pharma, said: "Despite
numerous initiatives in the past decades, S. aureus remains a major burden in
the post-surgical setting. Nasal carriage of S. aureus is associated with a
higher incidence of infections following surgery and significant morbidity and
mortality for patients. This interaction with the FDA gives us clarity on the
US registration pathway to filing a New Drug Application for XF-73 Nasal gel.
Once approved, XF-73 Nasal gel will provide a new antimicrobial for rapidly
and effectively decolonising nasal S. aureus and significantly reducing the
patient risk and burden of the associated post-surgical infections."

 

Alexander F. Mericli M.D., F.A.C.S. Associate Professor of Plastic Surgery at
The University of Texas MD Anderson Cancer Center, noted: "If this compound is
successful, it would be a game changer and revolutionise the safety of breast
reconstruction (BR) surgery. The main complication that is most feared by
breast surgeons is an infection. So, any effort or technology that decreases
that fear, is incredibly valuable and a triumph for the field."

 

The MD Anderson Cancer Center is a centre of excellence for cancer research
and treatment, and it has been ranked the No. 1 hospital for cancer care in
the US by different surveys.

 

Neil Clark, Chief Executive Officer of Destiny Pharma, added: "There is a
significant, global commercial opportunity for XF-73 Nasal gel to help prevent
hospital infections and to effectively decolonise patients undergoing a wide
range of medical treatments. Its target product profile is to be a safe, fast
and effective decolonising nasal gel that is cost effective for hospitals and
easy to use in standard surgical protocols. The excellent progress our
clinical team is achieving in the final design stages of the planned US Phase
3 clinical trial is fully in line with our stated strategy. This regulatory
clarity will also assist us in our XF-73 Nasal gel partnering discussions."

 

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 / Manel Mateus / 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 Broker)
Geoff Nash / Kate Bannatyne / George Dollemore, Corporate Finance

Alice Lane / Nigel Birks / Harriet Ward, ECM

+44 (0) 207 220 0500

 

MC Services AG
Anne Hennecke / Andreas Burckhardt

+49-211-529252-12

 

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)

 

Forward looking statements

 

Certain information contained in this announcement, including any information
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