Destiny Pharma (DEST ) said it has received positive feedback from the European Medicines Agency (EMA) following a review of Destiny’s proposed Phase 3 clinical programme design.
Destiny, a clinical stage innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections, said this ‘pivotal’ programme is expected to lead to the registration of its XF-73 nasal gel product as a new drug in Europe.
XF-73, Destiny’s lead drug candidate from its XF platform, is initially being developed to prevent post-surgical staphylococcal infections, such as methicillin-resistant Staphylococcus aureus (MRSA), which cause complications and increased healthcare costs in hospitals.
Today, Destiny has received positive scientific advice from the EMA stating that a ‘ simple, microbiological primary endpoint’ is acceptable for European approval of its XF-73 nasal gel.
The EMA stated that the XF-73 gel will measure the percentage of patients demonstrating decolonisation to a level of eradication. This is consistent with the primary endpoint used in the previous successful Phase 2b clinical study that reported ‘outstanding’ results in 2021.
The EMA’s advice also includes an agreement that the patient population that enrol in the Phase 3 trials will be those who are nasal carriers of S. aureus (around a third of all patients) undergoing surgeries that put them at risk of a post-surgical S. aureus or MRSA infection.
This is also consistent with the patient population enrolled in the successful Phase 2b trial.
It has also been agreed by the EMA’s stated advice that in Europe, the 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.
Additionally, the EMA outlined that it is in agreement with the proposed XF-73 Nasal gel product pack approach for Phase 3 and its commercial suitability for the European market.
Destiny Pharma said the EMA’s positive advice ‘identifies a clear route through European approval of XF-73 Nasal gel as a ground-breaking hospital infection prevention product.’
The Company said it is also in discussions with the US 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. To date, XF-73 has been awarded both Qualified Infectious Disease Product and Fast Track status by the US Food & Drug Administration.
Destiny said external findings of this research show XF-73 is seen as ‘a very promising alternative to the current standard of treatment, mupirocin, by both clinicians and payers.’
The company highlighted to investors that by addressing the unmet needs associated with mupirocin’s continued use, Destiny’s 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,’ it said.
The company added that the XF-73 nasal gel also has activity against a wider spectrum of Staphylococcal strains including MRSA strains while mupirocin resistance is increasing.
Neil Clark, CEO 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 the US.”
He added: “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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