REG - Destiny Pharma PLC - Clinical development update

Destiny PharmaAnnouncement

31/01/2024 07:00

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RNS Number : 4371B  Destiny Pharma PLC  31 January 2024

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 (mailto: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
amputation(1). 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 patients(2).

 

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
(http://www.destinypharma.com)

 

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