After F2G’s first attempt to get a brand-new class of antifungal to market was derailed by the FDA, the U.K.-based biotech has secured $100 million in fresh funding to bankroll another push towards commercialization next year.
The asset in question is olorofim, part of a new class of antifungal drugs called orotomides. The Shionogi-partnered candidate inhibits the dihydroorotate dehydrogenase enzyme to disrupt the synthesis of pyrimidines, compounds that are essential to fungi.
F2G has already requested approval from the FDA once, but in June 2023 the regulator said it required further data and analyses before it could reconsider the approval request.
This morning, the biotech announced it has secured $100 million in a series H funding round, with the money earmarked for completing the late-stage development of olorofim in invasive aspergillosis, as well as seeking regulatory approval and preparing for commercialization in the U.S.
Following “multiple productive meetings” between the biotech and the FDA, they have “aligned on a plan for resubmission using the existing phase 2 data, and we’re planning to submit towards the end of next year,” a spokesperson told Fierce Biotech.
New investor AMR Action Fund—a Big Pharma-backed initiative formed in collaboration with the World Health Organization and others—co-led the round with Intermediate Capital Group. Previous backers Novo Holdings, Advent Life Sciences, Sofinnova Partners, Forbion, Blue Owl, Morningside Ventures, Brace Pharmaceuticals and Merifin Capital all returned.
“We are delighted to attract this additional capital investment into F2G, and we are thrilled to be working with the AMR Action Fund, an important player in the antimicrobial space, and ICG, a leading alternative asset manager,” F2G’s CEO Francesco Maria Lavino said in the release.
“This is a pivotal period for the company as we conclude the final stages of development and preparation for commercialization of olorofim in the U.S. and elsewhere,” the CEO added. “If approved, olorofim is expected to be the first of a new class of antifungal agents with a novel, differentiated mechanism of action and will address genuine unmet needs in conditions with high morbidity and mortality.”
F2G submitted its initial approval application with data from the first 100 patients enrolled in a phase 2b study of the drug in various invasive fungal infections due to different resistant fungi. F2G's resubmitted application will take account of data from all 200 participants in the trial, the spokesperson said.
“While we don't need to generate new data, the timing of the resubmission reflects the time it will take to collect and package the updated historical control data,” they added.
The biotech also has a phase 3 study ongoing that is comparing olorofim to the approved antifungal AmBisome to treat invasive aspergillus.