This follows the FDA’s acceptance in February 2018 of an Investigational New Drug (IND) Application by the Company for the potentially ground-breaking drug.
Fast Track Designation is one of a package of measures and incentives available under the FDA’s Qualifying Infectious Disease Product (QIDP) programme, set up to encourage development of novel ant-infective drugs. XF-73 was awarded QIDP status in October 2015.
Fast Track designation is intended to expedite the potential availability of a drug to patients which, in the view of FDA, has promise in treating a serious or life-threatening condition and to fulfil an unmet medical need.
Destiny Pharma CEO Neil Clark said: “We are pleased to have received Fast Track designation from the FDA for XF-73. This represents a further recognition of the potential for the drug and the need for an effective prevention for post-surgical staphylococcal infections, such as MRSA, that can result in significant complications for patients and significantly increased costs for hospitals.
“ On our analysis of published data, there are approximately 40 million surgeries per annum, in the USA alone, where the patient is at risk of a post-surgical infection, We look forward to continuing our clinical development of XF-73 which remains on track and we expect Phase II data in 2019.”
XF-73 has been developed from Destiny Pharma’s novel, antimicrobial “XF” drug platform. Unlike traditional antibiotics, XF drugs have not been seen to generate bacterial resistance in industry-standard microbiology tests conducted 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.
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. XF-73 is targeted to address this important clinical need.