Destiny Pharma announced positive data and the non-irritant classification for its XF-73 nasal gel from its second Phase 1 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 prime objective of a low cumulative irritancy score, with high statistical significance as compared to a placebo of distilled water.
Positive data also supports second clinical programme of XF-73 in dermal infection indications.
Neil Clark said: “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.”