Destiny Pharma said it received positive feedback from the US Food and Drug Administration (FDA) on the proposed XF-73 Nasal US Phase 3 trial design and development programme.
XF-73 is initially being developed for the prevention of post-surgical staphylococcal infections, such as MRSA.
Destiny said the FDA has agreed to the proposed Phase 3 design comparing XF-73 nasal gel to placebo on top of standard of care to prevent staphylococcal infections after breast surgery.
This type of surgery is being proposed as patients can experience a relatively high infection rate following the current standard of care and there is a clear unmet medical need, said a statement.
Destiny added the FDA is also open to the collection of microbiological data during the proposed Phase 3 study that could lead to the development of a surrogate marker for clinical efficacy in other types of surgery.
Based on the favourable safety profile from the clinical development programme so far, the FDA has confirmed that no specialised nasal examinations are needed in the Phase 3 study.
In line with the above, the FDA has also removed the previous requirement to clinically evaluate skin sensitisation.
That means the Phase 3 study design can be simplified, said Destiny and can shorten the overall US clinical development programme.
Work is underway on finalising the US study design and biostatistical analysis to clarify the final patient numbers required and the related costings and timeline.
A primary endpoint for the trial will be statistically significant evidence that the use of XF-73 nasal gel results in fewer post-surgical site infections in breast surgery.
The AIM-listed group added it is also looking at a global Phase 3 programme that would consist of two studies and meet the requirements of both the FDA and European Medicines Agency (EMA).
Yuri Martina, Chief Medical Officer of Destiny Pharma, said: "Despite numerous initiatives in the past decades, S. aureus remains a major burden in the post-surgical setting.
“This interaction with the FDA gives us clarity on the US registration pathway to filing a New Drug Application for XF-73 Nasal gel.
Once approved, XF-73 Nasal gel will provide a new antimicrobial for rapidly and effectively decolonising nasal S. aureus and significantly reducing the patient risk and burden of the associated post-surgical infections."
"If this compound is successful, it would be a game changer and revolutionise the safety of breast reconstruction (BR) surgery" Alexander F Mericli, Associate Professor of Plastic Surgery at The University of Texas MD Anderson Cancer Center, said.
“The main complication that is most feared by breast surgeons is an infection. So, any effort or technology that decreases that fear is incredibly valuable and a triumph for the field."
In the US and worldwide, there are no approved nasal drugs for the prevention of post-surgical staphylococcal infections