Manchester, UK-based biotech F2G is celebrating news that its lead clinical candidate, the antifungal F901318, has been awarded Orphan drug designation in Europe.
The drug, the first member of a novel class of systemic antifungal agents called orotomides, is being developed for the treatment of invasive Aspergillosis and rare mould infections caused by Scedosporium species.
The orotomides are active against Aspergillus and other rare and resistant moulds and act via a completely different mechanism than currently marketed antifungals. Due to a new mechanism of action, this class of drugs is active against fungal infections resistant to current therapies, a growing problem globally, the firm noted.
"Given the global acknowledgement of increasing resistance of moulds to the azole antifungal class, we are delighted that the EMA has granted orphan drug status to F901318. We believe this agent will offer important therapeutic options to clinicians treating these deadly infections," said F2G's chief medical officer Dr John Rex.
Both oral and intravenous formulations of F901318 are being tested by the firm, and Phase II trials are scheduled for mid-2017.
Orphan designation means that F901318 will get up to ten years' market exclusivity following its authorisation in the European Union.