F2G, a U.K.-based biotech, has secured $100 million in funding to support the late-stage development and potential U.S. launch of olorofim, a novel antifungal treatment for invasive aspergillosis. This funding comes after the FDA issued a complete response letter to F2G's initial application, requesting additional data. The financing was co-led by the AMR Action Fund and ICG, with participation from eight other investors.
Invasive aspergillosis, a severe fungal infection primarily affecting individuals with weakened immune systems, often proves fatal. Current treatments face challenges due to increasing antimicrobial resistance and variable patient response. Olorofim represents a new class of antifungals known as orotomides, which disrupt a critical enzyme in the fungal metabolic pathway. The FDA previously granted olorofim Breakthrough Therapy designation based on Phase 2b study data.
"Fungal infections are a growing threat to patients around the world and have a disproportionate impact on vulnerable populations, yet there has been a paucity of innovation in the field of antifungals," said Henry Skinner, CEO of AMR Action Fund. Skinner will also join F2G’s board of directors.
Currently, F2G is conducting a Phase 3 trial comparing olorofim to AmBisome, an approved antifungal treatment. The $100 million will support the completion of this trial, address the concerns raised by the FDA, and prepare for the potential launch of olorofim in the U.S. "The capital raised is really a testament to the potential of olorofim, and also the confidence in F2G to advance it to the market," said Ralf Schmid, CFO of F2G. "We are optimistic that we will be able to address the concerns the FDA had."
F2G has partnered with Shionogi in Europe and Asia for the commercialization of olorofim. The funding round is expected to close in the fourth quarter, with Toby Sykes, managing director of ICG Life Sciences, also joining F2G’s board.
