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 of 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 proven invasive fungal disease (IFD) or probable invasive aspergillosis (IA) with limited treatment options.
Preliminary efficacy and safety data from this study were provided to the FDA as part of the ODD submission.
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.