28th January 2019 – Destiny
Pharma issued an announcement, which is summarized as follows:
Primary objective achieved by both XF-73 concentrations
Next step is key Phase 2b trial for XF-73 in the
prevention of post-surgical staphylococcal infections
Positive data also supports second clinical
programme of XF-73 in dermal infection indications
Destiny Pharma today announces positive data and the non-irritant classification for its XF-73 nasal gel from the second Phase 1 safety clinical study examining the drug’s potential to cause irritation when administered topically.
The study, required under the Investigational New Drug (IND) application opened in February 2018, achieved the primary objective of a low cumulative irritancy score for both concentrations (0.05% w/w and 0.2% w/w) with high statistical significance when compared to a placebo of distilled water.
Neil Clark, Chief Executive of Destiny Pharma, commented: “XF-73 nasal gel is planned to move into Phase 2b clinical trials under the US Food and Drug Administration (FDA) Qualified Infectious Disease Product (QIDP) and Fast Track designation. This study will examine the nasal antibacterial activity and safety of the 0.2% w/w XF-73 nasal gel in over 150 patients at risk of post-surgical infections. The study design is under review at the FDA and it is planned to report data towards the end of 2019.”
Original website link：
https://otp.tools.investis.com/clients/uk/destiny_pharma_ltd/rns/regulatory-story.aspx?cid=2241&newsid=1229034