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Destiny Pharma PLC on Wednesday said it has finalised development plans for phase three testing of its late-stage clinical asset, XF-73 Nasal, which aims to prevent post-surgical staphylococcal infections.
Destiny Pharma is a Brighton, England-based clinical-stage biotechnology company, focused on the development of novel medicines that can prevent life-threatening infections.
XF-73 Nasal is the company’s lead drug candidate from its XF platform. It is being developed for the prevention of post-surgical staphylococcal infections, such as methicillin-resistant staphylococcus aureus, or MRSA.
Following discussions with US and EU regulators, Destiny Pharma has decided that the phase three programme will consist of two studies, including patients in two well-defined surgery models.
One study will be in breast surgery as a model for general surgery, and the other will be in expedited orthopaedic surgery.
The programme, for which recruitment would start in 2024, pending a partnering deal, will include up to 2,000 patients.
Destiny Pharma said that successful clinical studies would give it a broad surgery label for its Nasal gel, thereby expanding product sales targets and maximizing commercial opportunities.
The company is targeting peak sales potential for the product of $1 billion.
‘There is a significant, billion-dollar, potential global commercial opportunity for XF-73 Nasal gel to help prevent hospital infections and to effectively decolonise patients undergoing a wide range of medical treatments,’ said Chief Executive Officer Neil Clark.
‘In line with our strategy for 2022, the clinical team has completed an extensive review, spoken with key regulators and finalised our Phase 3 development plans for XF-73 Nasal. While we gear up for the next steps, we are actively seeking a partner to join us in executing the Phase 3 development plans and lead the commercialisation of this exciting new medicine.’
Destiny Pharma shares closed 3.0% higher at 34.00 pence each in London on Wednesday.
By Holly Beveridge; Alliance News reporter
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