REG - Destiny Pharma PLC - Destiny Pharma's XF-73 Nasal Awarded MHRA ILAP

Destiny PharmaAnnouncement

11/06/2024 07:00

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RNS Number : 8632R  Destiny Pharma PLC  11 June 2024

Destiny Pharma plc

("Destiny Pharma" or "the Company")

 

Destiny Pharma Awarded Innovation Passport Designation by the UK MHRA for
XF-73 Nasal for the Prevention of Post-Surgical Site Infections

 

·    Innovation Passport provides entry to the UK's Innovative Licensing
and Access Pathway (ILAP), which aims to accelerate time to market and
facilitate patient access to innovative medicines in the UK for
life-threatening or seriously debilitating conditions, or conditions for which
there is a significant patient or public health need.

 

·    XF-73 Nasal is an innovative medicine developed to prevent
post-surgical infections and is potent against all MRSA strains.

 

Brighton, United Kingdom - 11 June 2024 - Destiny Pharma (AIM: DEST), a
clinical stage biotechnology company focused on the development and
commercialisation of novel medicines to prevent and cure life threatening
infections, today announced that the UK Medicines and Healthcare products
Regulatory Agency (MHRA) has granted an Innovation Passport under the
Innovative Licensing and Access Pathway (ILAP) to XF-73 Nasal for the
prevention of post-surgical site infections.

 

ILAP is unique as it aims to accelerate the time to market and facilitate
patient access to medicines in the UK for life-threatening or seriously
debilitating conditions, or conditions for which there is a significant
patient or public health need. The pathway provides access to the MHRA and its
partner agencies: the National Institute for Health and Care Excellence
(NICE); NHS England; National Institute for Healthcare Research (NIHR); Health
Research Authority (HRA); the Scottish Medicines Consortium (SMC); and the All
Wales Therapeutic and Toxicology Centre (AWTTC); who facilitate clinical
research activities and provide practical and regulatory support which fosters
an innovative and unified relationship with regulatory authorities. The
pathway actively incorporates the patient voice to help guide and accelerate
drug development; and input from NICE leads to early discussions around market
access, enabling pricing and reimbursement considerations to be factored in at
an earlier stage.

 

The MHRA ILAP Steering Committee noted that XF-73 Nasal is already at a late
stage of development and has a well-developed Target Development Profile which
can be developed through accessing the benefits offered by the ILAP toolkit
which includes recommendations from the Patient Engagement Team; clinical
trial application and guidance, alongside advice and Conditional Marketing
Authorisation.

 

Chris Tovey, Chief Executive Officer of Destiny Pharma, said: "XF-73 Nasal and
its successful Innovation Passport application builds upon its already
existing US FDA Qualifying Infectious Disease Product status, demonstrating
the significant regulatory endorsement and recognition of XF-73 Nasal's
potential in addressing the challenges of antimicrobial resistance."

 

Dr Bill Love, Chief Scientific Officer of Destiny Pharma added: "The clinical
data underpinning the XF‑73 Nasal programme is compelling with an excellent
safety profile and efficacy against a wide range of gram-positive bacteria
especially S.aureus, including MRSA, a leading cause of surgical site
infections. The award of ILAP is vital for ensuring this treatment is
available for patients' use as soon as possible."

 

Professor Mark Wilcox OBE, National Specialty Advisor Infection Prevention
& Control and Antimicrobial Resistance at NHS England and Head of
Microbiology Research & Development at Leeds Teaching Hospitals NHS Trust
commented: "MHRA's backing of XF-73 for the innovative medicines pathway is a
key step that should enhance the clinical development of this novel
anti-staphylococcal agent. As resistance to currently available
anti-staphylococcal antibiotics continues to evolve, speeding access for
patients to a new, safe and effective alternative antimicrobial is welcome
news."

 

The Company will now collaborate with ILAP to enable further development of
its innovative clinical trial designs to ensure rapid patient access, through
acceleration of time to market and early incorporation of key endpoints for
reimbursement. XF-73 Nasal is a Phase 3 ready asset designed to prevent
post-surgical infections occurring, including MRSA.

 

For further information, please contact:

 

Destiny Pharma plc

Chris Tovey, CEO

Shaun Claydon, CFO

+44 (0)1273 704 440

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

 

FTI Consulting

Ben Atwell / Simon Conway

+44 (0) 203 727 1000

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

 

Shore Capital (Nominated Adviser and Broker)

Daniel Bush / James Thomas / Lucy Bowden

+44 (0) 207 408 4090

 

About ILAP

The UK Medicines and Healthcare products Regulatory Agency (MHRA) launched
ILAP at the start of 2021 in order to accelerate the development of, and
access to, promising medicines. The pathway, part of the UK's plan to attract
life sciences development in the post-Brexit era, features enhanced input and
interactions with MHRA and other stakeholders. Other benefits
(https://url.avanan.click/v2/___https:/www.gov.uk/guidance/innovative-licensing-and-access-pathway___.YXAxZTpzaG9yZWNhcDphOm86YTgzNTY4M2FkNmQyNzcyNmJlNWViN2U1MzU0ZjJmN2U6Njo2OWQ2OjM1MjFlNTZiMzU3ZGUyMzE3M2Q5YjhjZTk4OWE0ZmRiZDc2Y2VlOGFkYTI0M2E5MTFkZjYwZjQwZTk0MThmYTM6cDpG)
of ILAP include access to a range of development tools, such as the potential
for a 150-day accelerated Marketing Authorisation Application (MAA)
assessment, rolling review and a continuous benefit risk assessment. More
information about ILAP can be found here
(https://url.avanan.click/v2/___https:/www.gov.uk/guidance/innovative-licensing-and-access-pathway___.YXAxZTpzaG9yZWNhcDphOm86YTgzNTY4M2FkNmQyNzcyNmJlNWViN2U1MzU0ZjJmN2U6Njo2OWQ2OjM1MjFlNTZiMzU3ZGUyMzE3M2Q5YjhjZTk4OWE0ZmRiZDc2Y2VlOGFkYTI0M2E5MTFkZjYwZjQwZTk0MThmYTM6cDpG)
.

 

About XF-73 Nasal

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.

 

About Destiny Pharma

Destiny Pharma is an innovative, clinical-stage biotechnology company focused
on the development and commercialisation of novel medicines that can prevent
life-threatening infections. The Company's drug development pipeline includes
two late-stage assets XF-73 Nasal gel, a proprietary drug targeting the
prevention of post-surgical staphylococcal hospital infections including MRSA
and NTCD-M3, a microbiome-based biotherapeutic for the prevention of C.
difficile infection (CDI) recurrence which is the leading cause of hospital
acquired infection in the US.

 

For further information on the company, please visit www.destinypharma.com
(https://url.avanan.click/v2/___http:/www.destinypharma.com___.YXAxZTpzaG9yZWNhcDphOm86YTgzNTY4M2FkNmQyNzcyNmJlNWViN2U1MzU0ZjJmN2U6NjoxYWQ4OmYzMjJhZGVkMjlkZTUxYjRlYTI3M2QxNTNjYzkyYmEzZGU0ZGNlMWEzN2E2NjE3YzA5NGFkOTRkZmRjZGUyYjc6cDpG)
.

 

Forward looking statements

Certain information contained in this announcement, including any information
as to the company'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 company's results of operations,
financial condition, prospects, growth, strategies and the industries in which
the company 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
company's control. Forward looking statements are not guarantees of future
performance. Even if the company's actual results of operations, financial
condition and the development of the industries in which the company 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.

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