The trial is the second phase 1 safety clinical study of XF-73, which evaluated its potential to cause dermal irritation when applied topically. Destiny Pharma has designed the drug for the prevention of post-surgical staphylococcal infections.
The phase 1 trial achieved the primary objective of a low cumulative irritancy score with high statistical significance in comparison to a placebo of distilled water.
Held in the US, the trial featured 35 volunteers who were subjected to two XF-73 nasal gel clinical formulations on intact and abraded skin at anti-Staphylococcal concentrations of 0.05% w/w and 0.2% w/w daily for 21 consecutive days.
The early-stage trial was carried out by the UK-based clinical stage biotechnology company as required under the Investigational New Drug (IND) application it filed in February 2018.
Destiny Pharma chief executive Neil Clark said: “We are very pleased with the positive outcome in this second Phase 1 study, which confirms the good safety profile of the XF-73 nasal gel formulation.
“We will now finalise plans for our 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.”
In the first phase 1 skin irritation study as well, Destiny Pharma reported positive data for the synthetic antimicrobial drug. As per the data released in July 2018, XF-73 in aqueous solution, at high concentrations, when applied daily for five days to intact and abraded skin was proved to have identical irritancy potential to water under occluded conditions.
Having cleared the two phase 1 studies, XF-73 will be moved into phase 2b clinical trials with its nasal gel formation to be examined for its nasal antibacterial activity and safety in more than 150 patients, who are prone to post-surgical infections.