F2G has bagged orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for olorofim (formerly F901318) for the treatments of invasive mold infections – invasive aspergillosis and lomentospora/scedosporium infections, and also the fungal infection – coccidioidomycosis (Valley Fever).
For the three infections, there are significant unmet medical needs.
In November 2019, F2G was granted breakthrough therapy designation to olorofim from the FDA for the treatment of the invasive mold infections.
Currently, the antifungal agent is being studied in an open-label single-arm phase 2b clinical trial in patients having proven invasive fungal disease (IFD) or probable invasive aspergillosis (IA) with limited treatment options.
Olorofim has been found to be well tolerated across more than 17 years of patient dosing days with a median therapy duration of 12 weeks. The UK- and Austria-based biotech company had submitted the preliminary efficacy and safety data from this study to the FDA as part of the ODD submission.
The orphan drug status from the FDA will help advance drug development for rare diseases.
Ian Nicholson – CEO of F2G said: “As we continue to work towards our goal of rapidly developing olorofim as a novel treatment for patients suffering from serious and life-threatening fungal infections, we are delighted to have been granted Orphan Drug Designation for the treatment of two specific fungal infections.
“Alongside the previously granted Breakthrough Therapy designation, this represents an important milestone and we look forward to continuing to work with the FDA to accelerate the development of this potentially life-saving therapy.”