Clinical stage biotechnology company, Destiny Pharma, has announced that the US Food and Drug Administration (FDA) has accepted its investigational new drug application (IND) for its lead clinical drug candidate, XF-73.
Investigational new drug
XF-73 is a synthetic anti-microbial active against all tested Staphylococcus aureus strains, including drug resistant strains. It works by affecting the bacterial membrane permeability and integrity, leading to cell death and has successfully gone through five clinical trials demonstrating rapid antibacterial action. It is being developed for the prevention of staphylococcal infections after surgery.
“Destiny Pharma is one of only a small number of UK biotech companies which have antibacterial drugs at the clinical stage of development. We are pleased to open the IND and are looking forward to starting the clinical programme and reporting the Phase 2 data in 2019,” stated Neil Clark, chief executive officer of Destiny Pharma. “The US is the largest potential market for this drug candidate and XF-73 could be the first drug approved for the US FDA’s newly defined indication of ‘prevention of post-surgical staphylococcal infection’. We look forward to continuing to advance XF-73 through clinical development.”
This drug candidate has been developed from the company’s antimicrobial drug platform. XF drugs have not, so far, been seen to generate bacterial resistance in microbiology tests so may be potential agents in the fight against antimicrobial resistance (AMR).
Under the IND, Destiny Pharma will now complete certain standard Phase I studies in the US and will also be able to finalise the study design of the Phase II clinical trial.