The Phase 1 skin irritation studies completed in 2018 and 2019 are the first data supporting the use of XF-73 on damaged skin. Following this positive data the Company is now planning to undertake further work on formulation development, in in vivo models and Phase 1 studies (potentially in patients with the target infections) with the aim of being ready to start Phase 2 studies in 2020. Destiny Pharma has the funding to complete the work required to build this Phase 2 ready package, which is now the second clinical programme in the Company’s pipeline.
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 drugs against gram‑positive and gram-negative bacteria, including 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 diabetic foot ulcers. The data that will be generated from this program over the next two years could also support a wide range of indications including impetigo, acne, atopic dermatitis, bacterial infected skin lacerations, candida skin/vaginal infection and treatment of serious bacterial burn wound infections.
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.