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
FTI
Consulting
Ben Atwell / Simon Conway
+44 (0) 203 727 1000
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 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.
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.
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