There are two XF-73 dermal programmes currently in development. One is being run by China Medical Systems Holdings Limited (CMS) – focused on superficial skin infections and the other is an in-house programme looking at the use of XF-73 for the prevention and treatment of serious infections associated with burns and open wounds including diabetic foot ulcers (DFUs). The company already has data supporting the efficacy in serious bacterial burn wound infection models in studies conducted in association with the US Department of Defense and the progress of this programme has greatly benefitted from a collaboration with the US government’s National Institute of Allergy and Infectious Diseases (NIAID) and has been granted Qualified Infectious Disease Product designation by the US Food and Drug Administration (FDA).
Phase 1 skin irritation studies have been completed and generated the first data supporting the use of XF-73 on damaged skin. Following this positive data, the Company is now performing further work on formulation development, in vivo models and Phase 1 study planning (potentially in patients, Phase 2a, with the target infections) with the aim of building a Phase 2/3 ready package.
The company has a strong Phase 1 clinical, pre-clinical, in vitro and in vivo infection model data set which demonstrates the efficacy of topically applied XF-73 against Gram positive and Gram negative bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), Pseudomonas aeruginosa and Acinetobacter baumannii. In some cases, unformulated XF drugs have been shown to be as active as existing, marketed antibiotics.
The data to be generated within AMR Bio’s development program for XF-73 as a new dermal drug will support a wide range of indications including bacterial infected diabetic foot ulcers, skin lacerations and candida skin/vaginal infection.