Destiny Pharma PLC (AIM:DEST) said it has received sign-off for the design of its phase III study of a nasal gel designed to prevent postoperative infections caused by staphylococcal infections such as the hospital superbug, MRSA.
The agreement with the European Medicines Agency has set the main goal for the clinical assessment as the percentage of people where the infection has been eradicated by Destiny’s XF-73 treatment.
This would mirror the successful phase IIb trial, the company pointed out.
Researchers will only recruit patients who are nasal carriers of S. aureus, which is around a third of the population.
Finally, the agreement of the EMA stipulates that XF-73 will be compared with the current standard of care, a dermal antibiotic called mupirocin.
Destiny also said it is also in discussions with the Food & Drug Administration over plans for a phase III evaluation in the US, where its nasal gel has fast track and qualified infectious disease product status designed to get it onto the pharmacists’ shelves quicker.
“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, said chief executive Neil Clark.
In the same release, the company shared market research that suggested XF-73 has the potential to supplant the current standard of care by addressing certain unmet needs.
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, Destiny said.
XF-73 also has activity against a wider spectrum of staphylococcal strains, including MRSA, while mupirocin resistance is increasing, it 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,” said CEO Clark.
Destiny estimates peak sales could exceed US$ 1bn in the US alone.