Positive interim safety review of Phase 2b clinical trial of lead asset XF-73 in the prevention of post-surgical bacterial infections
Brighton, United Kingdom – 11 August 2020 – Destiny Pharma plc (AIM: DEST), a clinical stage biotechnology company focused on the development of novel treatments for hospital infections that address the global challenge of antimicrobial resistance (AMR), announces a positive interim safety review has been completed by an Independent Data Monitoring Committee (IDMC) of the Company’s ongoing Phase 2b study of its lead asset XF-73 in the prevention of post-surgical bacterial infections.
Further to the announcement on 27 July 2020 detailing a US Food and Drug Administration approved clinical protocol amendment to the Phase 2b study, the IDMC has reviewed safety data from the first 75 cardiac surgery patients who have completed study treatment. Adverse event data, including safety laboratory results, incidence of post-operative infections, ear, nose, and throat examinations, as well as sense of smell tests were reviewed by the IDMC. Based on their evaluation, the IDMC has recommended that the study can continue without any modifications to the protocol. Recruitment into the study remains on track to complete by the end of 2020.
Neil Clark, Chief Executive Officer of Destiny Pharma, commented:
“We are very pleased the IDMC has concluded that there are no safety concerns in the patients treated in the Phase 2b study to date and that the study can continue as planned. This is consistent with our previous experience of testing XF-73 in several clinical studies. We believe XF-73 nasal gel has the potential to become a well-tolerated, novel and effective treatment for the prevention of post-surgical Staphylococcal infections and represents a significant commercial opportunity. We are now two thirds of the way through the study and look forward to completing recruitment by the end of 2020.”
The ongoing Phase 2b trial is a multi-centre, randomised, blinded, placebo-controlled study of multiple applications of a single concentration of XF-73 nasal gel to assess the microbiological effect of XF-73 on commensal Staphylococcal aureus nasal carriage in 125 patients scheduled for surgical procedures deemed to be at high risk of post-operative Staphylococcal aureus infection.
The Phase 2b study design is closely related to the successful 2016 clinical trial, which was funded by the National Institute of Allergy and Infectious Disease (part of the US National Institute of Health) and demonstrated the clinical efficacy of XF-73 versus placebo in reducing nasal Staphylococcus aureus carriage in healthy volunteers.
- Destiny Pharma plc
- Destiny Pharma plc