REG - Destiny Pharma PLC - XF-73 Nasal final Phase 3 development plans

Destiny PharmaAnnouncement

07/12/2022 07:01

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20221207:nRSG8100Ia&default-theme=true

RNS Number : 8100I  Destiny Pharma PLC  07 December 2022

Destiny Pharma plc

("Destiny Pharma" or the "Company")

 

Destiny Pharma announces finalisation of its Phase 3 development plans for
XF-73 Nasal

 

Targeting peak sales potential of $1 billion in the major markets

 

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, is pleased to
announce that it has now finalised plans for its Phase 3 studies for its
late-stage clinical asset, XF-73 Nasal.

 

Highlights

·     Discussions held with US and EU Regulators and Clinical Key
Opinion Leaders

·    Proposing two Phase 3 studies in two major surgery types to provide
a broad surgery label for XF-73 Nasal

·     Phase 3 programme will deliver an approvable data package for both
US and EU authorities.

·     XF-73 Nasal targeting peak sales potential of $1 billion in its
major target markets

·    Phase 3 patient recruitment could start in 2024 subject to
completing a XF-73 Nasal partnering deal in 2023

 

XF-73 Nasal 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 aim of the announced Phase 3 clinical programme is to deliver
comprehensive clinical trial data demonstrating that nasal decolonisation
using XF-73 Nasal, alongside "standard of care", reduces the incidence of post
-surgical infections in patients. This meets the requirements of both the US
and EU regulators - the FDA and EMA.

 

After a detailed review, the Company has decided that the Phase 3 programme
should consist of two Phase 3 studies including patients in two well-defined
surgery models. One study will be in breast surgery as a model for general
surgery and the other will be in expedited orthopedic surgery as a model of
orthopedic surgery.

 

This Phase 3 programme is expected to include up to 2,000 patients and deliver
a comprehensive data set supporting a clinical endpoint in Surgical Site
Infection ("SSI") reduction that is clinically and statistically significant.
Successful clinical studies will therefore provide Destiny Pharma with a broad
surgery label for its XF-73 Nasal gel thereby expanding product sales targets
and maximizing the commercial opportunity. Post-surgical infections create a
significant healthcare burden on hospitals and healthcare systems costing $10
billion per year in the US.  A single MRSA post-surgical infection costs over
$160,000 to treat and adds 15 days onto a hospital stay.

 

In parallel, Destiny Pharma is considering two additional indications for
XF-73 Nasal in oncology patients and in community acquired infections. These
extra Phase studies would provide supportive data and life cycle management
opportunities for XF-73.

 

Having clarified the Phase 3 study designs, the Company is now expanding its
partnering activities on XF-73 Nasal with the aim of securing a deal in 2023.

Dr. Yuri Martina, Chief Medical Officer of Destiny Pharma, said: "Having
finalized our Phase 3 strategy for our primary indication of SSI prevention,
we are ready for the next steps in executing our well-defined and validated
strategy. I am excited to see this compound approaching its final clinical
trials and move toward market approval. If successful, XF-73 Nasal will
deliver a much needed, novel treatment to help prevent surgical site
infections through nasal decolonisation, which is best practice in hospitals
across the world and an important unmet medical need for certain patient
populations and surgeries."

 

Neil Clark, Chief Executive Officer of Destiny Pharma, added: "There is a
significant, billion-dollar, potential 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. In line with our
strategy for 2022, the clinical team has completed an extensive review, spoken
with key regulators and finalized our Phase 3 development plans for XF-73
Nasal. While we gear up for the next steps, we are actively seeking a partner
to join us in executing the Phase 3 Development plans and lead the
commercialization of this exciting new medicine."

 

 

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 (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-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
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,
including the terms "believes", "estimates", "anticipates", "projects",
"expects", "intends", "aims", "plans", "predicts", "may", "will", "seeks"
"could" "targets" "assumes" "positioned" or "should" or, in each case, their
negative or other variations or comparable terminology, or by discussions of
strategy, plans, objectives, goals, future events or intentions. These
forward-looking statements include all matters that are not historical facts.
They appear in a number of places throughout this 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 to events and depend on circumstances that
may or may not occur in the future or are beyond the Group's control.
Forward-looking statements are not guarantees of future performance. Even if
the Group's actual results of operations, financial condition and the
development of the industries in which the Group operates are consistent with
the forward-looking statements contained in this document, those results or
developments may not be indicative of results or developments in subsequent
periods.

 

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  MSCUNSNRUSUURAA