Destiny Pharma
plc
("Destiny
Pharma" or "the Company")
Clinical development
update
Positive Results from XF-73
Dermal Safety Study
XF-73 Dermal to be progressed
towards clinical evaluation for the treatment of Diabetic Foot
Infections and serious burn wound infections
Update on NTCD-M3 programme
partnered with Sebela Pharmaceuticals
Brighton,
United Kingdom - 31 January 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 provides a
clinical development update on two of its programmes.
XF-73 Dermal
The Company is pleased to announce positive
data from a pivotal preclinical safety study of XF-73 Dermal, a
novel dermal formulation for the treatment of antibiotic resistant
skin infections associated with open wounds and broken skin.
Conducted as part of a non-clinical evaluation agreement with the
National Institute of Allergy and Infectious Diseases
(NIAID)1, the in
vivo safety study met all endpoints. The study examined the
potential toxicity of XF-73 Dermal following one, two and three
doses of XF-73 Dermal applied to broken skin and wounds weekly for
up to five weeks.
The product was well tolerated with no
significant impact on any clinical or safety parameters and had no
apparent negative impact on wound healing. Importantly, XF-73 was
retained locally at the site of wound application with negligible
amounts seen in the bloodstream, further supporting the safety
profile of this product. Subject to regulatory approval, these
positive safety results enable the progression of XF-73 Dermal into
clinical studies for evaluation in a wide range of serious infected
skin and wound conditions.
Following this positive study outcome, Destiny
Pharma intends initially to progress XF-73 Dermal towards clinical
evaluation for the treatment of Diabetic Foot Infections (DFI) and
serious burn wound infections, two areas with a clear unmet need
and large patient populations. The Company is confident in the
potential positive impact that XF-73 Dermal can provide in these
settings and will now explore the most appropriate route to move
the product forward in these indications.
NTCD-M3
In line with plans disclosed at the interim
results announced on 20 September 2023, the Company's management
has reviewed the Chemistry, Manufacturing and Controls (CMC)
programme for NTCD-M3, its product candidate for the prevention of
Clostridioides difficile
infection (CDI) recurrence. Following this review, the Company,
along with its partner, Sebela Pharmaceuticals ("Sebela"), has now
changed its contract development manufacturing organisation for
NTCD-M3 in order to strengthen manufacturing for clinical trial
material and improve future commercial supply. In doing so, this
supports the transition of NTCD-M3 from a liquid to a solid dose
formulation, which, based on market research is the preferred
formulation, and therefore further strengthens the competitive
profile of NTCD-M3.
These improvements to CMC, which are under the
remit of Destiny Pharma, mean that the company now expect drug
product for the next stage of clinical development to be available
in H2 2024. Sebela, who is responsible for the clinical development
plan, is assessing the impact of these changes on the development
plan. This may include a further Phase 2 study to de-risk Phase 3
study. As previously announced, Sebela has the right, at its own
cost, to complete any further trials.
Dr Bill Love,
Chief Scientific Officer of Destiny Pharma
said: "I
would like to thank NIAID for their support and collaboration
throughout the preclinical safety study in XF-73 Dermal and I am
delighted to announce this positive dataset. With these results, we can move XF-73
Dermal into the clinic with the confidence that it has the
potential to meaningfully improve outcomes in these two painful,
prevalent and potentially deadly conditions."
Chris Tovey,
Chief Executive Officer of Destiny Pharma,
added: "The
data from this XF-73 Dermal study are highly encouraging. There is
a significant unmet need in DFI and serious burn wound infections,
and we look forward to progressing our XF-73 Dermal product into
the clinic. Our research
across the XF-73 drug platform has demonstrated potency of XF-73
against thousands of different strains across Staphylococcus,
including MRSA, which are prolific in causing DFI and serious burn
wound infections. By moving forward with this asset, we will
broaden our pipeline in an area of significant market potential,
further validating the potential of the XF drug
platform to
reduce the emergence and impact of drug-resistant pathogens. I look
forward to providing further updates in due
course."
"For any drug
programme, the CMC elements of a development plan are critical to
its success and one of my first jobs has been to review the
integrity and robustness of the CMC for all our programmes and make
enhancements where they will add value for our
assets."
1 Part of the US
government's National Institutes of Health (NIH)
- END -
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
Shore
Capital (Nominated Adviser
and Broker)
Daniel Bush / James Thomas / Lucy
Bowden
+44 (0) 207 408 4090
About diabetic
foot infection and serious burn wound infections
Each year 18.6 million people worldwide are
affected by a diabetic foot ulcer, (1.6 million in the US) with 50
to 60% becoming infected. About 20% of moderate to severe DFI lead
to a lower extremity amputation and the five year mortality rate
for sufferers is 30% and exceeds 70% for those with a major
amputation1. Although burn wound infections are less
frequent, the consequences of infection are equally serious. Of
patients who experience greater than 20% body surface area burns,
up to 30% of these will go on to develop sepsis, a life-threatening
infection of the blood which represents the most common cause of
death in burn patients2.
References:
1. Armstrong DG, et al., (2023): Diabetic foot ulcers:
A review, Journal of the American
medical Association, Jul 3: 3; 330 (1): 62-75
2. Devorah JE et al. (2021) Review of sepsis in burn
patients in 2020, Surgical
Infection: 22:37-43
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 product, a
proprietary drug that is designed for the prevention of
post-surgical staphylococcal hospital infections (including MRSA),
and NTCD-M3, the world's most advanced live biotherapeutic
product (LBP) for the prevention of C. difficile infection (CDI) which is
the leading cause of hospital acquired infection in the US.
For further information on the company, please
visit www.destinypharma.com