Destiny Pharma PLC (AIM:DEST, OTC:DTTYF) has decided the phase 3 trial for its new anti-infective XF-73 Nasal will comprise two studies in different surgery types after consultations with the US Food and Drug Administration (FDA) and European regulators.
Aim-listed Destiny added it is now exploring partnering options for XF-73 Nasal with the aim of securing a deal in 2023.
The trial will aim to establish that nasal decolonisation using XF-73, alongside 'standard of care', reduces the incidence of post-surgical infections in patients, which was the requirement of both sets of regulators.
One study will be in breast surgery as a model for general surgery and the other will be in expedited orthopaedic surgery.
Up to 2,000 patients will be enrolled to deliver a comprehensive data set supporting a clinical endpoint in surgical site infection reduction.
In parallel, Destiny Pharma said it is considering two additional indications for XF-73 Nasal in oncology patients and in community-acquired infections.
Yuri Martina, chief medical officer, added: “If successful, XF-73 Nasal will deliver a much-needed, novel treatment to help prevent surgical site infections through nasal decolonisation, which is best practice in hospitals across the world and an important unmet medical need for certain patient populations and surgeries."
Neil Clark, Destiny's chief executive, added: “While we gear up for the next steps, we are actively seeking a partner to join us in executing the Phase 3 Development plans and lead the commercialization of this exciting new medicine."
Separately, Destiny also highlighted a new workshop it was involved in on how to prevent hospital-acquired infection that was organised by the US FDA and Centers for Disease Control (CDC) (full details here).
This provided a lot of encouragement for the company’s approach, it said.
Martina noted: “This workshop marks an important starting point for the FDA, CDC and the pharmaceutical industry to exchange ideas and thoughts which look at substantially increasing the development of new drugs addressing infection prevention.
“A shift in thinking is evident and it has been expressed by many of the speakers during the workshop.
“This encouragement from the FDA and CDC for new infection prevention products for the US market provides a supportive backdrop for Destiny Pharma's approach."
Post-surgical infections cost US$10bn per year in the US alone with an average case costing US$160,000 to treat with a patient staying an extra 15 days in hospital.