Positive data supports product opportunities for XF-73 in dermal infection indications
Custom Synthesis, Destiny Pharma’s first of two Phase 1 safety clinical studies of testing XF-73’s potential to cause dermal irritation, as Destiny’s lead candidate for the prevention of post-surgical staphylococcal infections, brought good news with positive results, which support the potential of XF compounds in dermal infection indications and also reinforce the target product profile of XF-73 in advance of it entering a Phase 2 clinical trial under the US Food and Drug Administration (FDA) Qualified Infectious Disease Product (QIDP) and Fast Track designations, Destiny announced on Thursday.
According to the company, the Phase 2 study will examine a nasal gel formulation of the drug for the prevention of post-surgical infections, which is on plan to report data in second half of 2019.
Destiny reminded that the Phase 1 clinical study, completed in the US under an Investigational New Drug (IND) from the FDA, showed that XF-73 in aqueous solution, at high concentrations, when applied daily for five days to intact and abraded skin (by tape stripping) has a similar irritancy potential to water under occluded (covered) conditions in a shorter version of an industry standard cumulative irritancy dermal safety study.
Neil Clark, Chief Executive of Destiny Pharma, said that he’s happy to see the confirmation of the safe profile shown in all other XF-73 clinical studies. He also said: “We are also excited that the abraded skin data supports the potential for the XF platform in treating difficult skin infections and we will now assess our drug development options in that therapeutic area.”
Destiny Pharma said that a second Phase 1 study with the XF-73 nasal gel formulation will be completed later in 2018 in a similar skin irritation potential safety volunteer trial.
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