Destiny Pharma (DEST ), a clinical stage biotechnology company, announced the commencencement of a preclinical safety study of its new XF-73 Dermal formulation.
XF-73 is the lead drug candidate from Destiny Pharma's XF platform, initially developed for the prevention of post-surgical staphylococcal infections, such as methicillin-resistant Staphylococcus aureus (MRSA).
Destiny Pharma has developed the dermal formulation of XF-73 for the prevention of infections associated with open wounds and broken skin including diabetic foot ulcers (DFUs). Up to 25% of US diabetic patients may suffer from DFUs in their lifetime.
The XF-73 Dermal product is planned to be a fast, cost-effective treatment that kills all relevant bacteria quickly, helping the wound heal and combatting the threat of antimicrobial resistance (AMR) through its patented action.
The study is the second of two planned studies of XF-73 Dermal, and will utilise a suite of preclinical services for interventional agent assessment held by the US National Institute of Allergy and Infectious Diseases (NIAID).
The first study met its objectives and generated positive data as reported in February 2022. Following a US FDA review of the first study, Destiny Pharma completed further development, regulatory, and clinical work, clearing the path for this second and final preclincial safety study.
The second and final study is planned to complete in Q2 2023 and should then be ready to move into clinical trials.
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Destiny Pharma continues to progress its development of XF-73 and its dermal variant. XF-73 Dermal aims to address a significant unmet clinical need, driven by the increasing incidence of diabetes across the world.
In the US alone, peak product sales could reach US$0.5bn as 29 million people are diagnosed with diabetes and at risk of developing diabetic foot ulcer infections.
The second preclinical study for XF-73 Dermal should deliver a second candidate in 2023 from Destiny's XF platform, following Phase 2 clinical results generated for the XF-73 Nasal gel for the prevention of post-surgical infections.
The US FDA has now clarified Phase III and a US registration pathway for XF-73 Nasal, and the European Medicines Agency has also given good feedback on XF-73 Nasal, identifying a clear route through European approval.
Destiny Pharma is also finalising preparation for a Phase III clinical trial of its NTCD-M3 treatment for the prevention C. difficile infection (CDI) recurrence. There are 500,000 annual cases of CDI in the US alone, leading to 29,000 deaths per year. With limited treatment options, CDI instances result in an additional c. US$6bn in annual healthcare costs in the US alone. Peak global sales of NTCD-M3 have therefore been estimated at US$1bn a year.
In summary, Destiny Pharma's two late-stage clinical assets present strong potential for future revenue as the market for infectious and respiratory disease prevention and treatment continues to grow. Both NTCD-M3 and XF-73 are supported by strong Phase II clinical data and address clear clinical needs with significant commercial opportunities. To this end, US and European regulatory work is progressing at a fast pace.
The company said its board was committed to taking these late-stage treatments through final Phase 3 clinical studies, to create significant value for shareholders in the near to medium-term.
DEST shares were up 4.3% on the news in early trading.
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