There are two XF-73 dermal programmes currently in development. One is being run by our China partner and shareholder – 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 such as diabetic foot ulcers (DFUs). The latter programme is in collaboration with the US government’s National Institute of Allergy and Infectious Diseases (NIAID).
Phase 1 skin irritation studies completed in 2019 were the first data supporting the use of XF-73 on damaged skin. Following these 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.
Destiny Pharma plans to develop XF-73 as a new dermal drug for the prevention/treatment of infections associated with foot ulcers. The data that will be generated from this programme over the next two years will support a wide range of indications including impetigo, acne, atopic dermatitis, bacterial infected skin lacerations, infected diabetic foot ulcers, candida skin/vaginal infection and treatment of bacterial burn wound infections.
CMS will look at opportunities in the China regional market for the prevention and/or treatment of superficial skin infections which are different to Destiny Pharma’s focus on infections related to deeper wounds and burns.
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.