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(Sharecast News) - Biotechnology developer Destiny Pharma announced the start of an investigational new drug (IND)-enabling safety study with its novel 'XF-73 Dermal' formulation.
The AIM-traded firm said the study would be the second of two planned preclinical safety studies of the XF-73 Dermal formulation, and would use a suite of preclinical services for interventional agent assessment held by the US National Institutes of Health (NIH).
It said the first study met its objectives and generated positive data, as it announced in February.
Following a US Food and Drug Administration (FDA) review of the first study, Destiny completed further work developing both the dermal formulation and potential regulatory and clinical plans, which cleared the path for progression into the second and final preclinical safety study.
Destiny said it was developing the novel formulation of XF-73 Dermal for the prevention of infections associated with open wounds and broken skin, including diabetic foot ulcers, which up to 25% of US diabetic patients could suffer in their lifetime, with 13% having active ulcers.
The XF-73 Dermal product was planned to be a "fast, cost-effective dermal treatment" that kills all relevant bacteria quickly, helping the wound heal and combating the threat of antimicrobial resistance through its novel, patented action.
Destiny said it would continue to work with the NIH to complete the preclinical safety package, which would support future clinical development of XF-73 Dermal in serious wound infections.
The study was expected to complete in the second quarter of 2023, at which point it should then be ready to move into clinical trials.
"We are very pleased with the continuing progress of our novel XF-73 Dermal infection programme which is targeted at meeting a clear clinical need driven by the increasing incidence of diabetes across the world," said chief executive officer Neil Clark.
"There are 29 million people diagnosed in the United States alone who are at risk of developing diabetic foot ulcer infections and peak product sales could reach half a billion US dollars.
"The start of this second preclinical study means that this programme is well placed to deliver a second clinical candidate in 2023 from our XF platform following the excellent phase 2 clinical results generated for the XF-73 Nasal gel for the prevention of post-surgical infections caused by staphylococcal aureus."
At 1144 GMT, shares in Destiny Pharma were up 5.71% at 37p.
Reporting by Josh White for Sharecast.com.
