US Center for Disease Control (CDC) and two major medical journals cite the importance of decolonization in preventing surgical site infections
pharmafile | January 25, 2023 | News story | Business Services |
Brighton, United Kingdom – 25 January 2023 – Destiny Pharma plc (AIM: DEST), a clinical stage biotechnology company focused on the development of novel products to prevent life-threatening infections, notes an increased focus on the importance of infection prevention by the Center for Disease Control (“CDC”), Food and Drug Administration (“FDA”), and the medical community in general, following a series of announcements and two publications in leading medical journals in recent weeks.
Destiny is developing its novel XF-73 Nasal gel for the prevention of post-surgical infections. XF-73 is the lead drug candidate developed from Destiny Pharma’s XF platform and 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.
Dr. Yuri Martina, Chief Medical Officer of Destiny Pharma, said: “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.
“Furthermore, it is important to note the two new papers in such respected journals as the Journal of the American Medical Association and the New England Journal of Medicine, which have both underlined the importance of decolonization in preventing post-surgical infections and complications. Both papers have also elaborated on the substantial impact of post-surgical infections for patients and the potential for long-term debilitation and life-threatening consequences. At Destiny Pharma, we are committed to progressing the Phase 3 clinical development of our XF-73 Nasal gel targeting nasal decolonization and delivering a new product to prevent post-surgical infections and the resulting complications for patients in hospitals around the world.”
CDC announcement underlines the need for new decolonization agents
On 28th December 2022, the CDC released a Broad Agency Announcement, following up on a CDC-FDA workshop held in August 2022, that clearly underlines the need for new decolonization agents, which have largely been missing in recent years, leading to an important gap in the public health portfolio of infection prevention. The Company believes this adds further support to its Phase 3 clinical strategy for XF-73 Nasal gel targeting nasal decolonization prior to surgery and indicates that regulators are increasingly aware of the importance and value of decolonization to help prevent infections. Prevention is better than cure.
Two major review publications supporting decolonization published
In January 2023, two important review papers on the key role of decolonization were published, by The Journal of the American Medical Association (“JAMA”) and The New England Journal of Medicine (“NEJM”).
The Journal of the American Medical Association
The JAMA review was authored by Dr. Deverick J. Anderson and colleagues at Duke Center for Antimicrobial Stewardship and Infection Prevention of the Duke University School of Medicine. In this review, the authors underline the following key points:
- A large number of patients experience post-surgical infections, often with severe morbidity and complications.
- Surgical site infections are among the most prevalent health care-acquired infections and result in significant costs, potentially reaching US$10 billion per year.
- Approximately 70-95% of surgical sites infections are caused by the patient’s endogenous flora. Among these, S. aureus is the most common cause of infection.
- Several risk factors are associated with surgical site infection. Some can be modified, but others cannot be impacted.
- Nasal decolonization has shown a substantial reduction in surgical site infections and especially in high-risk surgeries like orthopaedic and cardiothoracic procedures.
- Nasal decolonization should be achieved as close to surgery as possible, as this is the time when it is most effective.
- The current standard of care requires a fairly long procedure and consequently a significant amount of coordination.
The New England Journal of Medicine
The NEJM review was authored by Dr. Robin Patel from the Division of Clinical Microbiology, Department of Medicine at the Mayo Clinic, and focuses on the topic of periprosthetic joint infection (PJI). In this paper, Dr. Patel discusses the importance of prevention to reduce the burden of PJI and its impact on the healthcare system and the patients. Importantly, Dr. Patel underlines the following critical points:
- PJI is a serious complication of orthopaedic surgery with an average frequency of 2.3%.
- PJI complication is costly and burdensome for the patient and the healthcare system. The author estimates additional cost of US$391,000 for a PJI of the hip.
- PJI is associated with extended hospital stay, less-than-ideal success rates, decreased quality of life, pain, and high mortality.
- Reducing risks factors is not always possible and some risk factors cannot be influenced.
- A major impact on reducing PJI incidence can be achieved by implementing proper decolonization protocols.
