REG - Destiny Pharma PLC - XF-73 advances to clinically enabling safety study

Destiny PharmaAnnouncement

15/11/2022 07:01

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RNS Number : 3259G  Destiny Pharma PLC  15 November 2022

Destiny Pharma plc

("Destiny Pharma" or "the Company")

 

XF-73 Dermal infection project advances into clinically enabling safety study
as part of ongoing agreement with US Government's NIAID

 

Brighton, United Kingdom, 15th November 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 the commencement of an Investigational New Drug (IND) enabling safety
study with its novel XF-73 Dermal formulation.

 

This study is the second of two planned preclinical safety studies of the
XF-73 Dermal formulation and will utilise a suite of preclinical services for
interventional agent assessment (Contract No.
HHSN272201800001I/75N93023F00001) held by the National Institute of Allergy
and Infectious Diseases (NIAID), part of the US National Institutes of Health
(NIH). The first study met its objectives and generated positive data as
announced in February 2022. Following a US Food and Drug Administration (FDA)
review of the first study, Destiny Pharma has completed further work
developing both the dermal formulation and potential regulatory and clinical
plans, which has cleared the path for progression into this second and final
preclinical safety study.

Destiny Pharma is developing the novel formulation of XF-73 Dermal for the
prevention of infections associated with open wounds and broken skin including
diabetic foot ulcers (DFUs) - up to 25% of US diabetic patients may suffer
from DFUs in their lifetime and c. 13% have active ulcers. The XF-73 Dermal
product is planned to be a fast, cost-effective dermal treatment that kills
all relevant bacteria quickly, helping the wound heal and combatting the
threat of Antimicrobial Resistance (AMR) through its novel, patented action.

Destiny Pharma will continue to work with NIAID to complete this preclinical
safety package which will support future clinical development of XF-73 Dermal
in serious wound infections. The study is planned to complete in Q2 2023 and
should then be ready to move into clinical trials.

Neil Clark, CEO of Destiny Pharma, said: "We are very pleased with the
continuing progress of our novel XF-73 Dermal infection programme which is
targeted at meeting a clear clinical need driven by the increasing incidence
of diabetes across the world. There are 29 million people diagnosed in the
United States alone who are at risk of developing diabetic foot ulcer
infections and peak product sales could reach half a billion US dollars. The
start of this second preclinical study means that this programme is well
placed to deliver a second clinical candidate in 2023 from our XF platform
following the excellent Phase 2 clinical results generated for the XF-73 Nasal
gel for the prevention of post-surgical infections caused by Staphylococcal
aureus."

 

For further information, please contact:

 

Destiny Pharma plc

Neil Clark, CEO

Shaun Claydon, CFO

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

+44 (0)1273 704 440

 

Optimum Strategic Communications

Nick Bastin, Manel Mateus, Eleanor Cooper

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

+44 20 3922 0891

 

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

Alice Lane / Nigel Birks / Harriet Ward, ECM

+44 (0) 207 220 0500

MC Associates AG

Anne Hennecke / Andreas Burckhardt

+49-211-529252-0

 

Stern IR - US

Janhavi Mohite

+1-212-362-1200

 

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™, 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)

 

About XF-73

 

XF-73 is the lead drug candidate from Destiny Pharma's XF platform, initially
being developed for the prevention of post-surgical staphylococcal infections,
such as methicillin-resistant Staphylococcus aureus (MRSA), which cause
significant complications and increased healthcare costs in the hospital
setting. XF‑73 has been awarded both Qualified Infectious Disease Product
(QIDP) and Fast Track status by the US FDA.

 

Dermal Infections

 

XF-73 is being developed as a new treatment for serious dermal infections such
as diabetic foot ulcer infections (DFUs) to target a market which is estimated
to be a $0.5 billion global sales opportunity based on the incidence of such
infections, the costs of the associated medical care and a realistic product
pricing of XF-73 in this new market. Driven by the growing number of diabetics
and associated complications such as infected DFUs, this represents a
significant market opportunity for XF-73. It is estimated that twenty-nine
million people in US have a diagnosis of diabetes and of these 13% have active
DFUs.

As with all anti-infectives, AMR is also a concern within this market. There
is no dominant treatment for DFUs, and specialist physicians are therefore
working to find better treatment options, including topical formulations. In
addition, the target product profile of XF-73 tested favourably with dermal
clinicians looking for better treatments for the smaller market for
burns/wound infections and venous leg ulcers.

Destiny's China partner CMS is also running a programme for XF-73 in
superficial skin infections
(https://www.destinypharma.com/wp-content/uploads/2021/09/Destiny-Pharma-plc-Expansion-of-clinical-pipeline-27-September-2021.pdf)
.

 

Forward-looking statements

Certain information contained in this announcement, including any information
as to the Group's strategy, plans or future financial or operating
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Directors concerning, among other things, the Group's results of operations,
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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
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