Destiny Pharma’s XF-73 anti-bacterial drug delivers encouraging data in US clinical trial

The National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health, sponsored the two-stage study, which was carried out at the NIAID Clinical Trials Unit at Case Western Reserve University in Cleveland and at Anaheim Clinical Trials in California.

The safety, tolerability, and efficacy of intra-nasally applied exeporfinium chloride gels was evaluated in the study.

The first stage generated safety data in eight volunteers and enabled progression to second stage in 48 healthy volunteers with colonised nasal Staphylococcus aureus (SA) bacteria.

The double-blinded, placebo controlled, second stage assessed two exeporfinium chloride concentration gels (0.5 & 2.0mg/g) and two viscosities (2% and 4%) applied into the nostrils for five days.

Both concentrations were deemed safe and well-tolerated, and no drug was identified in the bloodstream.

Destiny Pharma said there was a similar safety profile seen in exeporfinium chloride and placebo-treated subjects, which is important because the product will be used in a preventive manner.

In general, exeporfinium chloride showed a quick, anti-staphylococcal effect after one day, with the 2.0mg/g gel demonstrating a statistical difference against placebo, which was sustained throughout dosing.

Destiny Pharma CEO Bill Love said: “We are delighted with these results, which demonstrate that exeporfinium chloride is safe and well tolerated and has the potential to deliver the FDA/QIDP awarded US indication for the prevention post-surgical SA infection.

“The support from NIAID made this study possible and we plan to progress this important new drug into the next stage of development and thereon to market.”