Extending the clinical pipeline

Their pipeline of novel antimicrobials include eight so far tested of those classed as urgent threats by the World Health Organisation and Centers for Disease Control (CDC), including MRSA (methicillin-resistant Staphylococcus aureus). 

 

DEST is progressing its lead program for Prevention of post-surgical Staph infection with intra nasal candidate XF-73 and is on track to commence Phase IIb studies later this year. The company has also extended its clinical pipeline by adding a new program for high unmet need in treatment and / or prevention of skin infections in diabetic foot ulcers (DFU’s) and in burns wounds. High unmet need in DFU and burns gives a global peak annual sales potential of up to $500m, and with XF-73 already shown to be active against the predominant pathogens associated with infection in these indications. 

 

A Phase IIb study for a gel formulation of XF-73 in the new FDA indication for prevention of post-surgical Staphylococcus aureus infection, is due to be launched on completion of a second standard safety study of the gel formulation of XF-73 in H2’18. Existing safety data in 166 subjects suggest that this is a relatively low risk hurdle to achieve. The timeline for the Phase IIb study completion remains on track and is anticipated in H2’19. 

 

DEST has also started Phase I studies of XF-73 in two additional indications, for Diabetic Foot Ulcer DFUs and burns wounds. This follows on from Phase I study results showing that XF-73 is a suitable treatment for longer term treatment. This will be confirmed during additional Phase I studies planned in 2019, targeting the completion of a Phase II ready package in during 2020. This demonstrates the potential versatility of the drug being tested, for both preventative and treatment approaches.

 

The group reported a healthy cash balance of £15.1m at June 2018 – sufficient to run the ongoing planned studies of XF-73 – taking the cash runway into H2’20 on our forecasts including funding to complete a Phase II ready package for XF-73 dermal program.