Destiny Pharma plc, a clinical stage biotechnology company focused on the development of novel products to prevent life-threatening infections, has announced positive top-line results from the Phase 2b clinical study testing its XF-73 nasal gel as a new product for the prevention of post-surgical infections such as methicillin-resistant Staphylococcus aureus (MRSA). The trial demonstrated that the treatment is highly likely to be effective, with an excellent safety profile.
Staphylococcus and similar bacteria are resistant to many different antibiotics. The bacteria are carried by around a third of the population – typically in the nasal passage – and generally do not cause any harm, but present a much higher risk in the aftermath of surgical procedures, when they can multiply and cause dangerous infections while the immune system is weakened.
Four doses of XF-73 nasal gel were administered to patients in the 24 hours before incision and the start of surgery. XF-73 was shown to reduce S. aureus bacteria carried in the nose by 99.5%, a very effective reduction by accepted clinical measures. This reduction was more than 99% greater than a placebo in the same patient population, and the effect was maintained during surgery, with no treatment-related adverse effects. Full results will be published in due course in a peer reviewed journal.
There is a global need for better treatments such as XF-73 which has been awarded Qualifying Infectious Disease Product (QIDP) and Fast Track status by the US FDA. Destiny Pharma now plans to discuss possible Phase 3 clinical study designs with regulatory bodies including the US FDA. The Company believes that there is a significant commercial opportunity for XF-73 in the hospital setting which could generate peak annual product sales of up to $1 billion in the US alone.
Richard Proctor, MD, Professor Emeritus of the Department of Medical Microbiology/Immunology and Department of Medicine at University of Wisconsin School of Medicine and Public Health, and a member of the Company’s Scientific Advisory Board, said: “The completion of the Phase 2b clinical trial with XF-73 nasal gel is an important milestone in the fight against Staphylococcus aureus infections that occur in surgical patients. These infections can be reduced by decreasing the numbers of S. aureus in the nose prior to surgery.
“XF-73 nasal gel was very well tolerated and highly effective in clearing these organisms. This antibacterial drug has a new mechanism of action which appears to address bacterial resistance enabling widespread use, unlike antibiotics. This trial is an important step in the fight against this worldwide epidemic of antibiotic resistant S. aureus (including MRSA) as all attempts to date to develop a S. aureus vaccine have failed.”
Julie E. Mangino MD, FSHEA, FIDSA, Professor Emeritus at The Ohio State University College of Medicine and Chair of this Phase 2b Data Safety and Monitoring Committee, commented: “The rapid onset of XF-73’s nasal S. aureus decolonization shown in this Phase 2 study represents highly encouraging news for patients who are to undergo surgery and are at risk of post-operative staphylococcal infections as well as for hospitals working to prevent them.”
Neil Clark, Chief Executive Officer of Destiny Pharma, said: “We are delighted with these excellent results. We have delivered strong confirmation from this Phase 2b study of the potential of XF-73 to prevent post-surgical infections such as MRSA caused by the bacteria Staphylococcus aureus.
“There is a significant global commercial opportunity for XF-73 nasal gel to help prevent hospital infections and this excellent data supports the proposed target product profile for XF-73 as being a safe, fast, effective decolonising nasal gel that is cost efficient and easy to use in standard surgery protocols. Critically, XF-73’s rapid mechanism of action does not generate Antimicrobial Resistance (AMR) as demonstrated in peer reviewed publications and it can therefore help in the fight against superbugs.”
For more information visit https://clinicaltrials.gov/ct2/show/NCT03915470
Destiny Pharma conducts proprietary and contract research within the pharmaceutical R&D business sector.