F2G raises $100M to bring antifungal drug back to FDA

U.K.-based biotechnology company F2G has raised $100 million to complete late-stage testing of a new kind of antifungal treatment and bring it back to U.S. regulators’ desks after they rejected it last year.

AMR Action Fund, a public-private group working to accelerate antimicrobial drug development, co-led the fundraising with ICG. A slate of eight other investors joined.

F2G is studying a drug called olorofim for treating invasive aspergillosis, a serious fungal infection caused by the Aspergillus species of mold. A Phase 3 trial is currently ongoing.

Invasive aspergillosis is a severe form of aspergillosis infection that starts in the lungs before spreading to other parts of the body. It typically occurs in people with weakened immune systems and can be fatal. Initial treatment generally involves existing antifungal medications, but antimicrobial resistance can make infections harder to manage. Some people also don’t respond well to those medications.

“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, in a statement. Alongside the funding, Skinner will join F2G’s board of directors.

F2G’s candidate, olorofim, is a new type of treatment. Known as an orotomide antifungal, it works to kill the fungus by disrupting a key enzyme. The Food and Drug Administration granted olorofim a Breakthrough Therapy designation back in 2019 and F2G later submitted it for approval based on data from the first 100 patients enrolled in a Phase 2b study.

But the FDA rejected F2G’s application, asking for more data that the company hopes to obtain via its ongoing Phase 3 test. The agency’s letter gave the company substantial guidance, company CFO Ralf Schmid told BioPharma Dive, and the company remains confident in the drug’s prospects.

“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 Schmid. “We are optimistic that we will be able to address the concerns the FDA had.”

F2G’s Phase 3 study pits olorofim against an approved antifungal treatment called AmBisome. The $100 million the company raised will also be used to prepare for launching the drug in the U.S., should it receive an approval “in the not so distant future,” Schmid said.

F2G has partnered with Japan-based pharmaceutical company Shionogi in Europe and Asia.

Along with Skinner, Toby Sykes, managing director of ICG Life Sciences, will join F2G’s board. Novo Holdings, Forbion, Advent Life Sciences, Blue Owl Healthcare Opportunities, Sofinnova Partners, Brace Pharmaceuticals, Merifin Capital and Morningside Ventures were also involved in the funding, which is expected to close in the fourth quarter.

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