Regulatory Affairs

FDA accepts Destiny Pharma's IND for XF-73 clinical drug candidate

PBR Staff Writer Published 27 February 2018

The US Food and Drug Administration (FDA) has accepted Destiny Pharma’s investigational new drug application (IND) for its anti-infective clinical drug candidate, XF-73.

XF-73 is being developed to prevent post-surgical staphylococcal infections such as Methicillin Resistant Staphylococcus aureus (MRSA).

XF-73 is a synthetic anti-microbial agent, which is active against all tested Staphylococcus aureus strains, including drug resistant strains.

It affects the bacterial membrane permeability and integrity by acting via cell-surface mechanism, helping to cause cell death.

Based on the firm’s XF drug platform, the novel XF-73 was demonstrated to kill bacteria, making it to be considered as an effective new treatment to reduce bacterial infections in hospital patients.

XF-73 is administered topically as a nasal gel to reduce the nasal carriage of the bacteria Staphylococcus aureus, which is responsible for multiple post-surgical bacterial infections.

The acceptance of IND will allow Destiny Pharma to complete certain standard Phase 1 studies in the US and finalize the study design of the Phase 2 clinical trial for XF-73.

The phase 2 study is being designed to assess the nasal anti-staphylococcal efficacy and clinical safety of XF-73 compared against placebo in pre-surgical patients at risk of infection.

The study design will be based on successful 2016 clinical trial that showed the clinical efficacy of XF-73 against placebo in reducing nasal Staphylococcus aureus carriage in healthy volunteers.

Destiny Pharma CEO Neil Clark said: “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.

“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.”