Destiny Pharma meets recruitment deadline for XF-73 trial

Clinical-stage biotechnology company Destiny Pharma announced on Tuesday that its XF-73 phase 2b clinical trial was fully recruited by 31 December, meeting the target timeline set for the programme.

The AIM-traded firm described XF-73 as a first-in-class drug candidate from its XF platform, initially being developed for the prevention of post-surgical staphylococcal infections, such as methicillin-resistant staphylococcus aureus (MRSA), which cause “significant” complications and increased healthcare costs in the hospital setting.

It was awarded both qualifying infectious disease product (QIDP) and fast track status by the US Food and Drug Administration (FDA).

The phase 2b trial was 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 staphylococcus aureus nasal carriage in up to 125 patients scheduled for open heart surgery.

Destiny said the trial design was closely related to the successful 2016 clinical trial, which was funded by the US National Institute of Allergy and Infectious Disease, and demonstrated the efficacy of XF-73 versus placebo in reducing staphylococcus aureus nasal carriage in healthy volunteers.

Previous clinical and scientific data supported XF-73 as having a novel mechanism of action and being a safe, fast and targeted anti-infective agent, the directors said.

In microbiological studies it was also shown to not generate antimicrobial resistance, and this had the potential to have a “clear advantage” over older antibiotic treatments that can lead to the generation of drug resistant ‘superbugs’, according to the company’s board.

“We are very pleased to have completed enrollment in our phase 2b clinical trial testing XF-73 nasal gel as a novel product preventing the incidence of post-surgical infections such as MRSA,” said chief executive officer Neil Clark.

“We previously reported excellent interim safety data in mid-2020 and are now looking forward to announcing the full results of this study and planning the Phase 3 clinical programme.

“There is a global need for better treatments to prevent post-surgical infections in hospitals as recognised in the fast track status awarded to XF-73 by the FDA.”

Clark said there was also a “significant” commercial opportunity for XF-73 in the hospital setting, which the company estimated could generate peak annual product sales of $1bn in the US alone.

“2020 was a transformational year for Destiny Pharma as we accelerated our strategy to build a world leading anti-infection company with a robust pipeline.

“We established a biotherapeutic/microbiome pipeline alongside our existing XF platform and are now co-developing SPOR-COV as a novel, preventive treatment for Covid-19.”

Clark noted that the firm also raised £10.4m to acquire NTCD-M3 - a phase 3 ready biotherapeutic treatment for the prevention of C. difficile infection recurrence.

“The news today on our XF-73 phase 2b study is another major milestone for the company, and we continue to look forward to announcing the study results in the first quarter of 2021.”

At 1214 GMT, shares in Destiny Pharma were up 5.86% at 73.04p.