Destiny Pharma announces encouraging results of US clinical trial

Biopharmaceutical developer Destiny Pharma Ltd has announced positive results from a US clinical trial of its novel preventive anti‐bacterial drug exeporfinium chloride (XF‐73), which has the potential to kill hospital 'superbugs', reports The Sunday Times. The trial is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health, and was conducted at the NIAID Clinical Trials Unit at Case Western Reserve University in Cleveland and at Anaheim Clinical Trials in California.

XF-73 is designed to be applied as a nasal spray, to protect patients at risk of post-surgical infections including MRSA - an antibiotic-resistant strain of Staphylococcus aureus (SA) bacteria. In the US alone, it is estimated that the annual cost of SA infection is $14.5bn, and that drug-resistant forms of SA, such as MRSA, result in 19,000 deaths per year. A report in The Lancet in December 2015 estimated that between 38% and 51% of bacteria that cause post-surgical infections are resistant to  traditional antibiotics, and that a 30% reduction in antibiotic effectiveness could result in 120,000 additional post-surgical and chemotherapy-related infections in the US each year.

The two‐stage clinical trial studied the treatment's safety, tolerability, and efficacy, and included a double-blinded, placebo-controlled study in healthy volunteers with colonised nasal SA bacteria. XF-73 was deemed safe and well-tolerated in concentrations of both 0.5 and 2mg/g, and no drug was detected in the bloodstream. Crucially for a preventive treatment, a similar safety profile was observed in both subjects treated with XF-73 and a placebo. In general, XF-73 demonstrated a rapid anti‐staphylococcal effect after 1 day, with the 2mg/g gel showing a statistical difference against the placebo, which was sustained throughout dosing.

In October 2015, the US Food & Drug Administration (FDA) recognised XF-73 as a Qualifying Infectious Disease Product (QIDP), and confirmed a new medical indication for the drug, namely for the 'Prevention of Post‐Surgical Staphylococcal Infections'. Compared to antibiotics, XF-73 has a novel structure and mechanism of action, killing SA bacteria rapidly without appearing to generate resistance. These features make it an ideal candidate for the prevention of post‐surgical SA infection.

Dr Bill Love, CEO of Destiny Pharma 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 of 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."