Clinical-stage biotech company Destiny Pharma announced today (July 19) positive information from the Food and Drug Administration (FDA) regarding its Phase 3 development plans for XF-73 Nasal Gel.
The FDA has clarified the Phase 3 and US registration pathway for the gel for the prevention of postoperative staphylococcal infections, and this feedback allows for simplification of the study design and reduction of the overall clinical development time.
The Brighton-based UK company, which focuses on developing new products to prevent life-threatening infections, said it was pleased to report positive feedback from a lead drug candidate developed on its XF platform.
It was originally developed to prevent postoperative staphylococcal infections, such as methicillin-resistant Staphylococcus aureus (MRSA), which can cause significant complications and increase hospital care costs.
The FDA agreed to a proposed phase 3 design comparing XF-73 nasal gel with placebo as an adjunct to the standard of care for the prevention of postoperative staphylococcal infections after certain breast surgeries. This type of surgery is suggested because patients may face a relatively high infection rate according to the current standard of care and an obvious unmet medical need.
A surrogate marker
The FDA said it is open to collecting microbiological data during the proposed phase 3 study, which could lead to the development of a surrogate marker for the clinical effectiveness of other types of surgery.
Based on the favorable safety profile from the clinical development program thus far, the FDA has confirmed that no special nasal studies are required in the Phase 3 study. Accordingly, the FDA also removed the previous requirement for clinical evaluation of skin sensitization.
Regulatory feedback will allow Destiny Pharma to streamline its Phase 3 study design and is expected to shorten its overall US clinical development program
Yurii Martina, Chief Medical Officer of Destiny Pharma, said: “Despite many initiatives in recent decades, S. aureus (MRSA) remains a major burden in the postoperative setting. Nose carrier S. aureus is associated with a higher incidence of post-surgical infections and significant patient morbidity and mortality. This interaction with the FDA gives us clarity on the US registration path to the submission of a new drug application for XF-73 Nasal Gel. Once approved, the gel will be a novel antimicrobial agent for the rapid and effective decolonization of nasal S. aureus and a significant reduction in the risk and burden of associated post-surgical infections for the patient.”
Based on the FDA’s feedback, Destiny Pharma is now focused on finalizing the US study design and biostatistical analysis to clarify the final patient population and associated costs and timelines. The company is also exploring the possibility of developing a global phase 3 clinical program, likely to consist of two studies, that meets the requirements of both the FDA and the European Medicines Agency (EMA). .
The breast surgery patient population for the phase 3 clinical trial was selected in accordance with FDA requirements for a “placebo plus standard of care” comparison, with the primary endpoint being statistically significant evidence that the use of the gel results in fewer postoperative infections. .
The company said it is confident the positive Phase 3 results will mean the nasal gel will be used in breast surgery and more broadly in many other surgical procedures where decolonization is recommended. It is estimated that about a third of the world’s population are carriers S. aureususually in the nose, putting them at much greater risk of post-operative infection.
As such, nasal decolonization is recommended in many high-risk surgeries, which is a very large patient population in the US and worldwide, meaning the gel is targeting a multi-billion dollar market in the hospital setting. The need for better antimicrobial treatments like XF-73 Nasal Gel is highlighted by the fact that XF-73 was previously awarded FDA Qualifying Infectious Disease Product (QIDP) and Fast Track status.
At the moment, there are no approved nasal preparations for the prevention of postoperative staphylococcal infections. A common antibiotic called mupirocin was used to treat patients who carry the bacteria before surgery to reduce the risk of infection. However, the use of existing preventive treatment is severely limited by the existence and fear of drug-resistant bacteria.
In contrast, the nasal gel has been shown not to create drug-resistant bacteria, which Destiny Pharma says reduces the threat posed by AMR (antimicrobial resistance). In addition, the company says its resistance profile makes it ideal for widespread use in the prevention of post-surgical infections.
Neil Clarke, CEO of Destiny Pharma, added: “There is a significant global commercial opportunity for XF-73 Nasal Gel to help prevent hospital-acquired infections and effectively decolonize patients undergoing a wide range of medical procedures. Its intended product profile is to be a safe, rapid and effective decolonizing nasal gel that will be cost-effective for hospitals and easy to use in standard surgical protocols. The excellent progress our clinical team is making in the final stages of development of a planned US phase 3 clinical trial is fully consistent with our stated strategy. This regulatory clarity will also assist us in our partnership discussions on XF-73 Nasal Gel.”
https://www.labiotech.eu/trends-news/fda-positive-news-nasal-gel-clinical-study-mrsa/ Good news for Destiny Pharma’s infection-fighting nasal gel