Olorofim gets Orphan Drug designation to treat IFD

April 4, 2020 0 By FM

F2G Ltd announced that the US FDA has granted Orphan Drug Designation (ODD) to its olorofim (formerly F901318) for treatment of invasive aspergillosis and lomentospora/scedosporium infections.

In November 2019, olorofim was granted Breakthrough Therapy designation by the FDA.

Olorofim is currently being investigated in an open-label single-arm phase 2b study in patients with the proven invasive fungal disease (IFD) or probable invasive aspergillosis (IA) with limited treatment options. 

The phase 2b study for olorofim is a global open-label study in patients who have limited treatment options for difficult-to-treat invasive fungal mould infections such as azole-resistant aspergillosis, scedosporiosis, lomentosporiosis, and other rare mould infections. 34 centres are currently open in six countries (AU, BE, ES, NL, USA, IS) and a further 12 will open in 2020. 

Olorofim is being developed both as IV and oral formulations.