Brighton, UK-based Destiny Pharma has announced a positive interim safety review of its ongoing Phase IIb study of its lead antibiotic asset XF-73.
Destiny Pharma is focused on the development of novel treatments for hospital infections that tackle the global threat of antimicrobial resistance (AMR).
The company’s proprietary XF drug platform acts via an ultra-rapid action that kills targeted bacteria, including antibiotic resistant strains, and also makes bacteria unable to mount a resistance.
Destiny’s lead asset is currently being studied in a Phase IIb, multi-centre, randomised, blinded and placebo-controlled trial for the prevention of post-surgical bacterial infections, including Staphylococcal aureus.
An Independent Data Monitoring Committee (IDMC) has now reviewed safety data from the first 75 cardiac surgery patients who have completed study treatment.
Adverse event data, which includes 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.
The IDMC recommended that the study can continue without any modifications to the protocol after the review, finding no concerning safety issues. According to Destiny, study recruitment is on track and is set to complete by the end of 2020.
“We are very pleased the IDMC has concluded that there are no safety concerns in the patients treated in the Phase IIb 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,” said Neil Clark, Chief Executive Officer of Destiny Pharma.
“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,” he added.
