The second of two planned preclinical safety studies has started for Destiny Pharma’s XF-73 dermal formulation.
The company announced the start of an investigational new drug (IND) today (November 15) and is developing the formulation for the prevention of infections associated with open wounds and broken skin including diabetic foot ulcers (DFUs).
This second study will utilize a suite of preclinical services for interventional agent assessment held by the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH).
Destiny Pharma starts IND
The first study met its objectives and generated positive data as announced in February 2022. Following a US Food and Drug Administration (FDA) review of the first study, Destiny Pharma has completed further work developing both the dermal formulation and potential regulatory and clinical plans, which has cleared the path for progression into this second and final preclinical safety study.
Destinity Pharma says up to 25% of US diabetic patients may suffer from DFUs in their lifetime and around 13% have active ulcers. The XF-73 Dermal product is planned to be a fast, cost-effective dermal treatment that kills all relevant bacteria quickly, helping the wound heal and combatting the threat of antimicrobial resistance (AMR) through its novel, patented action.
The company will continue to work with NIAID to complete this preclinical safety package which will support future clinical development of XF-73 Dermal in serious wound infections. The study is planned to complete in the second quarter of next year (2023) and should then be ready to move into clinical trials.
Neil Clark, CEO of Destiny Pharma, said: “We are very pleased with the continuing progress of our novel XF-73 Dermal infection program, which is targeted at meeting a clear clinical need driven by the increasing incidence of diabetes across the world.
“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 U.S. dollars.
“The start of this second preclinical study means that this program is well placed to deliver a second clinical candidate in 2023 from Destiny Pharma’s 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.”