Destiny Pharma (DEST ), a clinical stage biotechnology company, issued a note detailing an increased focus on infection prevention by the US CDC and FDA regulators as well as the medical community at large, following recent announcements and publications in leading medical journals.
Destiny released the note as context for its XF-73 Nasal candidate for the prevention of post-surgical infections. XF-73 Nasal is Destiny's flagship candidate, being developed for the prevention of post-surgical staphylococcal infections, such as MRSA. In 2022 Destiny defined a US and EU Phase 3 clinical development plan for XF-73 Nasal and is currently running a partnering campaign.
The US Center for Disease Control (CDC) released a Broad Agency Announcement on December 28, underlining the need for new decolonisation agents that have been largely missing from the US public health portfolio in recent years. The CDC has made a call to simplify the pathway to regulatory approval for decolonisation agents and established the need for new surrogate endpoints.
Review papers in leading US medical journals published in support of decolonisation
Two recently published papers in the Journal of American Medical Association (JAMA) and the New England Journal of Medicine (NEJM) have also made the case for increased focused on decolonisation:
The JAMA review points to the large number of patients experiencing post-surgical infections, often with severe morbidity and complications. The paper explains that surgical site infections are among the most prevalent health care-acquired infections, resulting in significant costs of up to US$10bn a year.
The 0paper identifies nasal decolonisation as being particularly effective in treating surgical site infections, especially in high-risk surgeries like orthopaedic and cardiothoracic procedures.
The NEJM review focuses on periprosthetic joint infection and discusses the importance of prevention to reduce the burden of PJI and its impact on the healthcare system.
PJI is a serious complication of orthopaedic surgery with an average frequency of 2.3%. It is costly and burdensome for the patient and healthcare system, with an estimated additional cost of US$391k for a PJI of the hip. PJI is associated with extended hospital stays, decreased quality of life, pain, and high mortality.
The NEJM paper concludes that a major impact on reducing PJI incidence can be achieved by implementing proper decolonisation protocols.
Dr. Yuri Martina, Chief Medical Officer of Destiny Pharma, commented: "The Centre for Disease Control's announcement clearly recognizes the need for new and effective decolonization agents and their importance for public health. They have made a clear call to simplify the pathway to regulatory approval and suggested the need for establishing new surrogate endpoints. Destiny Pharma views this as a very encouraging shift in the agency's thinking that could be very supportive to our clinical development of XF-73 Nasal."
View from Vox
In summary, the US CDC and the medical community have begun to recognise the importance and value of effective decolonisation agents in preventative care and maintaining public health. Naturally, the rationale for this is that prevention is better and cheaper than care. The move by the CDC adds further support to Destiny Pharma's Phase 3 clinical strategy for its flagship XF-73 nasal gel candidate, which targets nasal decolonisation prior to surgery.
Destiny has now finalised its Phase 3 development programme for XF-73 Nasal. After discussions with the US FDA and EU EMA, the company has proposed studies in two major surgery types (breast cancer and orthopedic surgery) to provide a broad surgery label for XF-73 Nasal, targeting a peak sales potential of US$1bn in its major markets.
The Phase 3 programme will deliver an approvable data package for US and EU authorities with recruitment due to start in 2024, data potentially available in 2025, and filings for approval expected in 2026.
Before that, Destiny is targeting a partnering deal for Phase 3 development and commercialisation of XF-73 Nasal, planned for 2023.
XF-73 Nasal aims to address a significant unmet clinical need. Post-surgical infections create a considerable healthcare burden on hospitals and healthcare systems, costing US$10bn per year in the US. A single MRSA post-surgical infection costs over US$160k to treat and adds 15 days to a hospital stay.
XF-73 Nasal is already supported by strong Phase 2 clinical data as is Destiny's other major asset NTCD-M3 for the prevention of CDI recurrence. Both late-stage clinical assets address clear clinical needs and present strong potential for future revenue as the market for infectious and respiratory disease prevention and treatment continues to grow.
Follow News & Updates from Destiny Pharma: