(Sharecast News) - Clinical-stage biotechnology company Destiny Pharma said on Tuesday that it has received positive scientific advice from the European Medicines Agency (EMA), following its review of its proposed phase 3 clinical programme design.
The AIM-traded firm said the pivotal programme was expected to lead to the registration of the XF-73 nasal gel as a new drug in Europe.
It also announced findings from a recently-commissioned independent market research study, which it said reinforced the clinical support and market potential of XF-73 masal gel in Europe.
Destiny described XF-73 as the lead drug candidate from its 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 hospitals.
The company said the EMA indicated that a "simple, microbiological primary endpoint" would be acceptable for European approval, which would measure the percentage of patients demonstrating decolonisation to a level of eradication.
That would be consistent with the primary endpoint used in the "very successful" phase 2b clinical study, that reported "outstanding results" in 2021.
It was agreed that in Europe, XF-73 nasal gel would be compared to a 'standard of care' mupirocin treatment in the phase 3 programme, given mupirocin is the old dermal antibiotic widely used across the world for nasal decolonisation.
Destiny also confirmed the EMA had agreed to 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 board said in its statement.
Destiny was also in discussions with the United States Food and Drug Administration (FDA) on a study design suitable to gain US approval which, combined with the EMA feedback, would finalise the global phase 3 clinical strategy for the product.
XF-73 was previously awarded both Qualified Infectious Disease Product (QIDP) and Fast Track status by the FDA.
"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," said chief executive officer Neil Clark.
"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."
Clark described a "very exciting time" for the XF-73 nasal gel product, explaining that finalising the study designs would provide clarity on the clinical trial size and costs, which would be 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 $1bn in the US alone."
At 1418 GMT, shares in Destiny Pharma were up 2.61% at 90.3p.
Destiny Pharma. (DEST)18 Apr 2024 14:17