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)
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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
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