Clinical stage biotech company, Destiny Pharma, announced today (July 19) a positive update from the U.S. Food and Drug Administration (FDA) on its XF-73 nasal gel phase 3 development plans.
The FDA has clarified the phase 3 and U.S. registration pathway for the gel for the prevention of post-surgical staphylococcal infections, and this feedback enables the study design to be simplified and the overall clinical development times to be shortened.
The Brighton, UK-based company focuses on the development of novel products to prevent life-threatening infections, said it was pleased to announce the positive feedback from the lead drug candidate developed from its XF platform.
It is initially being developed for the prevention of post-surgical staphylococcal infections, such as methicillin-resistant staphylococcus aureus (MRSA), which can cause significant complications and increased healthcare costs in the hospital setting.
The FDA agreed to the proposed phase 3 design comparing XF-73 nasal gel to the placebo on top of standard of care for the prevention of post-surgical staphylococcal infections following certain breast surgery operations. 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.
The FDA said it is 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 favorable safety profile from the clinical development program so far, the FDA has confirmed that no specialized nasal examinations are needed in the phase 3 study. In line with this, the FDA has also removed a previous requirement to clinically evaluate skin sensitization.
The regulatory feedback will enable Destiny Pharma to simplify the phase 3 study design and is expected to shorten the overall clinical development program in the U.S.
Yuri Martina, chief medical officer of Destiny Pharma, said: “Despite numerous initiatives in the past decades, S. aureus (MRSA) remains a major burden in the post-surgical setting. Nasal carriage of S. aureus is associated with a higher incidence of infections following surgery and significant morbidity and mortality for patients. This interaction with the FDA gives us clarity on the U.S. registration pathway to filing a new drug application for XF-73 nasal gel. Once approved, the gel will provide a new antimicrobial for rapidly and effectively decolonizing nasal S. aureus and significantly reducing the patient risk and burden of the associated post-surgical infections.”
Based on the FDA’s feedback, Destiny Pharma is now focused on finalizing the U.S. study design and biostatistical analysis to clarify the final patient numbers required and the related costings and timeline. The company is also exploring the possibility of designing a global phase 3 clinical program, likely to consist of two studies, that meets the requirements of both the FDA and European Medicines Agency (EMA) and a further update on this will be made in due course.
The breast surgery patient population for the phase 3 clinical trial has been chosen to meet FDA requirements for a “placebo plus standard of care” comparator with the primary endpoint being statistically significant evidence that the use of the gel results in fewer post-surgical site infections.
The company said it is confident positive phase 3 results will mean the nasal gel will be used in breast surgery and more widely in the many other surgical procedures where decolonization is recommended. It is estimated that approximately one third of the global population are carriers of S. aureus, typically in the nose, putting them at a significantly higher risk of acquiring a post-surgical infection.
Consequently, nasal decolonization is recommended across many high-risk surgeries which is a very large patient population in the U.S. and across the world meaning that the gel is targeting a multi-billion dollar market opportunity in the hospital setting. The need for better anti-microbial treatments such as XF-73 nasal gel, is underlined by XF-73 having previously been awarded FDA Qualifying Infectious Disease Product (QIDP) and Fast Track status.
At the moment there are no approved nasal drugs for the prevention of post-surgical staphylococcal infections. A general antibiotic called mupirocin has been used to treat patients who carry the bacteria before they undergo surgery to reduce the risk of infection. However, the use of existing preventative treatment is severely limited by the existence and fear of generating drug resistant bacteria.
In contrast, the nasal gel has shown that it does not generate drug-resistant bacteria which Destiny Pharma says reduces the threat posed by AMR (anti-microbial resistance). To add to this, the company says the resistance profile makes it ideally suited for widespread use in the prevention of post-surgical infections.
Neil Clark, CEO at Destiny Pharma, added: “There is a significant, global commercial opportunity for XF-73 nasal gel to help prevent hospital infections and to effectively decolonize patients undergoing a wide range of medical treatments. Its target product profile is to be a safe, fast and effective decolonizing nasal gel that is cost effective for hospitals and easy to use in standard surgical protocols. The excellent progress our clinical team is achieving in the final design stages of the planned US phase 3 clinical trial is fully in line with our stated strategy. This regulatory clarity will also assist us in our XF-73 nasal gel partnering discussions.”