Destiny Pharma receives positive results from XF-73 Dermal safety study
(DEST ) has reported positive data from the first of two preclinical safety studies of its lead XF-73 dermal formulation which it is developing for the prevention of infections associated with open wounds and broken skin including diabetic foot ulcers.
The biotechnology company, which is focused on developing medicines that can prevent life threatening infections for patients, is conducting the two studies as part of a non-clinical evaluation agreement with the National Institute of Allergy and Infectious Diseases (NIAID).
The NIAID forms part of the US National Institutes of Health, the primary federal agency of the United States government responsible for conducting biomedical and public health research.
Destiny confirmed that the first study met its objectives and generated positive data, therefore ‘clearing the path for its progression into the second and final clinically‑enabling regulatory safety study.’ Both studies are being conducted through NIAID’s suite of preclinical services.
The company said it will continue to work alongside the NIAID to complete this preclinical safety package that is intended to support future clinical development of XF-73 Dermal in serious wound infections, adding that the study is planned to be completed in 2022.
Neil Clark, Chief Executive Officer of Destiny Pharma, said: “We are very pleased with the encouraging data from our novel XF-73 dermal formulation which is aimed at meeting a clear clinical need in a large market where peak product sales could reach half a billion US dollars.
He added: “This programme is well placed to deliver a second clinical candidate 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.”
Last week, Destiny Pharma said a new study had confirmed the potential of its therapeutic NTCD-M3 as a novel treatment to prevent the recurrence of Clostridioides difficile infections.
The new study, which was reported by the US Department of Veterans Affairs, had also indicated that NTCD-M3 could be used alongside all standard-of-care antibiotic treatments.
The research confirmed NTCD-M3's ability to colonise the gut after antibiotic administration. Destiny told investors that this confirmation strengthens the market opportunity of the therapeutic because it supports its use following commonly used antibiotic treatments.
The study was undertaken with the Edward Hines, Jr. VA Hospital in Illinois, which conducts advanced research into the diagnosis, epidemiology, prevention, and treatment of CDI.
In addition, Destiny has reported findings from North American and European market research which it said reinforce the clinical support and market potential of NTCD-M3.
Destiny explained that Clostridioides difficile occurs in the gut when oral antibiotics kill beneficial bacteria in the gut, causing unintentional and harmful collateral damage.
CDI, which releases toxins which cause disease, is the leading cause of hospital acquired infection in the United States, and current treatments can lead to significant recurrence.
In the United States, there are around 500,000 cases of CDI each year; many of these initial cases then recur leading to 29,000 deaths per year. It is estimated that CDIs result in an additional US$6 billion in healthcare costs per year in the US alone, Destiny told investors.
Destiny said the results provide further support and rationale for the use of NTCD-M3 as an adjunct to both current standard-of-care treatments for the prevention of CDI recurrence.
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