Brighton, United Kingdom, 15th November 2022 – Destiny Pharma plc (AIM: DEST), a clinical stage innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections, is pleased to announce the commencement of an Investigational New Drug (IND) enabling safety study with its novel XF-73 Dermal formulation.
This study is the second of two planned preclinical safety studies of the XF-73 Dermal formulation and will utilise a suite of preclinical services for interventional agent assessment (Contract No. HHSN272201800001I/75N93023F00001) held by the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH). 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.
Destiny Pharma is developing the novel formulation of XF-73 Dermal for the prevention of infections associated with open wounds and broken skin including diabetic foot ulcers (DFUs) – up to 25% of US diabetic patients may suffer from DFUs in their lifetime and c. 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.
Destiny Pharma 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 Q2 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 programme 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 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.”
Full Press Release available here.