23th September 2019– Destiny Pharma issued an announcement, which is summarized as follows:
Phase 2b clinical trial: XF-73 nasal gel for prevention of post-surgical infections
– XF-73 (exeporfinium chloride) nasal gel Phase 2b trial has started enrolling 200 surgical patients in sites in the US and Europe
– European site set-up on schedule but US sites slower than expected. Consequently, recruitment expected to complete in early 2020 with results announced later in mid-2020 (previously recruitment was planned to end in Q4 2019)
– Interim safety, efficacy and futility analysis of Phase 2b trial, performed by independent safety monitoring board, planned for end of 2019
– Prototype XF-73 nasal gel pack for the final marketed product is being developed to deliver an easy-to-use, single dose, nasal gel tube to enable precise delivery and reduce wastage
– “Non-irritant” classification awarded to XF-73 nasal gel following positive results from a Phase 1 safety clinical study examining the drug’s potential to cause irritation when administered topically. This classification supports lead nasal programme and use in Phase 1 dermal infection project
Neil Clark, CEO of Destiny Pharma, commented:
“Destiny Pharma has made good progress in the first half of the year and we are very pleased to have started recruitment of patients into the important Phase 2b study of our lead drug candidate, XF-73, for the prevention of post-surgical hospital infections. This is a major milestone for the Company and we look forward to reporting results in mid-2020 with patient recruitment planned to complete in Q1 2020.
We remain very positive on the clinical need and commercial opportunity for XF-73 in the hospital setting which we estimate in the US alone to be peak annual product sales of $1 billion. Our discussions with potential US hospital clinical trial sites and new, independent US studies confirm the increase in the decolonisation of nasal carriers of Staphylococcal aureus in the US as “best practice” ahead of major surgeries.
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