* New US indication QIDP designated by FDA, October 2015
# Gram negative (Acinetobacter baumannii and Pseudomonas aeruginosa) and Gram positive (Staphylococcus aureus) bacteria
The Destiny Pharma pipeline is composed of clinical and preclinical assets for the prevention and treatment of bacterial infections.
The patented XF drugs, exemplified by XF-73, possess a unique array of features that lend themselves to the treatment and prevention of bacterial infections. The combination of the rapid bactericidal action, activity in biofilms and the lack of observed resistance development give them particular utility in indications where emerging antibiotic resistance threatens current treatment options.
The XF Drug Platform includes both the XF drug series and the related DPD drug series and incorporates an array of compounds based around a di-cationic porphyrin ring structure and is protected by a series of global patents and agreements.
CLINICAL STAGE PRODUCTS:
Prevention of Post-Surgical Staphylococcal Infections:
XF-73 (exeporfinium chloride) the Company’s lead drug is in clinical development for a new, QIDP designated, US indication of The Prevention of Post-surgical Staphylococcal Infections.
A clinical trial agreement between the Company and the National Institute of Allergy & Infectious Disease (NIAID), has enabled the opening of an Investigational New Drug (IND) to evaluate XF-73 in a Phase I study. This study has successfully completed and was reported in September 2016. Further Phase 1 studies are underway and a Phase 2b is on track to be completed in 2019.
XF-73 has completed four successful Phase I /IIa studies in Europe.
These trials have provided the foundation data outlined below;
- Excellent clinical safety profile
- Well tolerated at multiple doses
- No systemic exposure
- Clear Anti- aureus efficacy data verses placebo
- Rapid Anti- aureus action
Dermal infection treatments:
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 topical 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.
PRE-CLINICAL STAGE PRODUCTS:
Respiratory infection prevention:
The properties of XF-73 could be extended into the area for the prevention of staphylococcal respiratory infections such as hospital and ventilator associated pneumonia (HVAP), where there is a growing understanding of the role of Staphylococcus aureus carriage and lung infections.
Clearly other respiratory treatment opportunities are available to pursue for XF drugs including inhaled product for the treatment of antibiotic resistant strains of Gram positive pathogens, including those where biofilm involvement may exacerbate the infection.
Biofilm Product Opportunities:
XF Drugs have demonstrated activity against staphylococci within formed biofilms. This is a potentially advantageous feature as many antibiotics cannot act against such bacteria within biofilms.
Bacterial biofilms are implicated in chronic and recurring infection and there is a growing understanding of their role and the value in developing strategies/products which can address this issue in tissue and medical device related infections. For example, bacterial biofilm is implicated in chronic lung infection in conditions such as cystic fibrosis where Staphylococcus aureus, including MRSA and Pseudomonas aeruginosa are the most common pathogens in this condition.
The Company was granted its US Biofilm patent in May 2016 having already obtained grant in the EU and will continue to develop products in this exciting new area. XF Drugs have shown the ability to act against S. aureus within formed biofilms which are protective against traditional antibiotics.