Phase 3 can use similar primary endpoint to the very successful Phase 2b clinical study
New European report underpins clinical need and market opportunity of XF-73 Nasal
Destiny Pharma today announces it has received positive Scientific Advice from the European Medicines Agency (EMA) following its review of Destiny Pharma’s proposed Phase 3 clinical programme design. This pivotal Phase 3 programme is expected to lead to the registration of the XF-73 nasal gel as a new drug in Europe.
The Company also announces findings from a recently commissioned, independent market research study which reinforces the clinical support and market potential of XF-73 Nasal gel in Europe.
XF-73 is the lead drug candidate from Destiny Pharma’s XF platform, initially being developed for the prevention of post-surgical staphylococcal infections, such as methicillin-resistant Staphylococcus aureus (MRSA), which cause significant complications and increased healthcare costs in the hospital setting.
The key highlights of the EMA advice are as follow:
– A simple, microbiological primary endpoint is acceptable for European approval of the XF-73 nasal gel. It will measure the percentage of patients demonstrating decolonisation to a level of eradication. This is consistent with the primary endpoint used in the very successful Phase 2b clinical study that reported outstanding results in 2021.
– Agreement that the patient population to enroll in the Phase 3 trials will be those who are nasal carriers of aureus (approximately a third of all patients) undergoing surgeries that put them at risk of a post-surgical S. aureus or MRSA infection. This is consistent with the patient population enrolled in the successful Phase 2b.
– It has been agreed that in Europe XF-73 Nasal gel would be compared to a “standard of care” mupirocin treatment in the Phase 3 programme; mupirocin is the old dermal antibiotic widely used across the world for nasal decolonisation.
– Agreement with the proposed XF-73 Nasal gel product pack approach for Phase 3 and its commercial suitability for the European market.
This positive advice is welcomed by the Company as it identifies a clear route through European approval of XF-73 Nasal gel as a ground-breaking hospital infection prevention product.
The Company is also in discussions with the FDA on a study design suitable to gain US approval which, combined with the EMA feedback, will finalise the global Phase 3 clinical strategy for the XF-73 Nasal gel product. XF-73 has been awarded both Qualified Infectious Disease Product (QIDP) and Fast Track status by the US Food & Drug Administration (FDA).
Qualitative market research
The external, independent findings of this research show that XF-73 Nasal gel is seen as a very promising alternative to the current standard of treatment, mupirocin, by both clinicians and payers. By addressing the unmet needs associated with mupirocin’s continued use, the study suggests XF-73 has the potential to replace the current standard of treatment as the preferred pre-surgical nasal decolonisation agent. Key to this is its one-day dosing which would improve patient compliance, enable use in emergency surgery and reduce pre-surgical preparation time for elective surgeries. XF-73 also has activity against a wider spectrum of Staphylococcal strains including MRSA strains while mupirocin resistance is increasing.
Neil Clark, Chief Executive Officer of Destiny Pharma, said: “We are very pleased with the detailed feedback received from EMA on the Phase 3 clinical trial plans for our XF-73 Nasal gel product. These studies will be the final step before registration in Europe. We are also continuing our discussions with the FDA to discuss our proposal for Phase 3 designs in US. This is a very exciting time for the XF-73 Nasal gel product since finalising these study designs will provide clarity on the clinical trial size and costs, which are key to securing partners for the programme. The Company remains very confident in the significant value of the XF-73 Nasal gel programme based on the excellent clinical data produced to date and the clear clinical need and significant market opportunity indicated by external, independent market experts. The Company estimates that peak sales could exceed US$ 1 billion in the US alone.”
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