Destiny Pharma’s XF-73 could be the first drug approved for the US FDA’s newly defined indication of prevention of post-surgical staphylococcal infection

UK-based developer of anti-microbial drugs, Destiny Pharma, has welcomed the news from the US FDA for acceptance of an Investigational New Drug Application for its lead clinical drug candidate XF-73, which is being developed for prevention of post-surgical staphylococcal infections such as Methicillin Resistant Staphylococcus aureus (MRSA), the company said on Monday.

The company’s CEO, Neil Clark, pointed out that Destiny Pharma is one of only a small number of UK biotech companies which have antibacterial drugs at the clinical stage of development. He said that opening the IND enables to start the clinical programme and reporting the Phase 2 data in 2019. “The US is the largest potential market for this drug candidate and XF-73 could be the first drug approved for the US FDA’s newly defined indication of “prevention of post-surgical staphylococcal infection”. We look forward to continuing to advance XF-73 through clinical development,” Clark said.

Destiny explained that XF-73 has been developed from Destiny Pharma’s novel, antimicrobial “XF” drug platform. Unlike most antibiotics, XF drugs have not been seen to generate bacterial resistance in industry-standard microbiology tests to date and therefore have significant potential to address the global threat of AMR. XF-73 has been shown to kill bacteria very rapidly and therefore may be an effective new treatment in the reduction of bacterial infections in hospital patients, including those caused by MRSA, the company has noted.

As stated at the IPO in September 2017, under the new IND, Destiny Pharma will now complete certain standard Phase 1 studies in the US and will also be able to finalise the study design of the Phase 2 clinical trial. This Phase 2 study will evaluate the nasal anti-staphylococcal efficacy and clinical safety of XF-73 compared to placebo in pre-surgical patients at risk of infection.

MRSA is one of the most prominent superbugs and a major cause of hospital associated infection and featured in the WHO’s ‘most dangerous’ list of superbugs published in 2017. The WHO followed US and European guidelines in 2016 by recommending the screening and decolonisation of MRSA and all strains of Staphylococcus aureus in pre-surgical patients undergoing high risk surgeries in a step designed to help prevent such infections.