Destiny Pharma’s XF-73 nasal gel formulation has been classified non-irritant, in the second Phase 1 study, which confirms the good safety profile, the company said.
According to the company’s stock exchange filling, the study 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, said the company will now complete plans for its key Phase 2b study testing XF-73 nasal gel as a novel therapy for the prevention of post-surgical staphylococcal infections, including MRSA.
“This is our lead indication targeting a billion-dollar US market and there is a clear medical need for a new drug that is safe, cost-effective and addresses the global medical concerns of anti-microbial resistance,” he said.
Clark said in the press release that the 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, he said. Furthermore, the study design is under review at the FDA and it is planned to report data towards the end of 2019.
By Dino Mustafić