Armed with $100m funding, F2G prepares to refile antifungal
UK biotech F2G has raised $100 million as it prepares to refile its olorofim candidate for invasive fungal infections, which was turned down last year by the FDA.
The Manchester-based company said the new cash will help it to complete the late-stage development of olorofim, a novel oral antifungal for invasive aspergillosis and other serious fungal infections, to support the company during the regulatory review process, and prepare for a commercial launch in the US.
F2G's first attempt to win FDA approval for olorofim resulted in a complete response letter (CRL) from the agency saying there was a need for additional data that meant it would be unable to complete its review within the allotted time.
The biotech has spent the intervening period running trials to shore up the data on the drug, which it hopes could end a two-decade drought in novel therapies for invasive fungal infections in the US.
Olorofim (formerly F901318) is the first in a new class of orotomide antifungal agents intended to provide a new treatment option for serious fungal infections when the current armamentarium of azoles, echinocandins, and polyene-based medicines fail. The FDA granted F2G a breakthrough designation for olorofim in 2019.
Since the first filing, F2G has completed a phase 2b study in patients with invasive aspergillosis, scedosporiosis, lomentosporiosis, fusariosis, scopulariopsis, and coccidioidomycosis infections and limited treatment options – which was ongoing when the FDA turned down the application in June 2023.
It has also started a 225-subject phase 3 trial called OASIS, comparing treatment with olorofim to Astellas' AmBisome (liposomal amphotericin B) in invasive aspergillosis, which should generate results next year.
Invasive aspergillosis is a serious infection that typically affects people with compromised immune systems and there are rising rates of resistance to azoles and amphotericin B, the two most effective classes of treatment.
The new financing was led by the AMR Action Fund, said to be the world's largest public-private partnership investing in the development of new antimicrobial therapeutics, and backed up by existing investors Novo Holdings, Advent Life Sciences, Sofinnova Partners, Forbion, Blue Owl Healthcare Opportunities, Morningside Ventures, Brace Pharmaceuticals, and Merifin Capital.
"For decades, clinicians have relied on a handful of antifungal classes, with few mechanisms of action and significant limitations due to spectrum of activity, drug toxicities, or drug-drug interactions," said AMR Action Fund's chief executive Henry Skinner, who has joined the board of F2G.
"These therapies are increasingly failing in patients," he added. "We are thrilled to support F2G's team as they develop this urgently needed therapy and seek regulatory approval."
Olorofim is licensed in Europe and Asia to Japanese pharma Shionogi, which paid $100 million upfront for rights to the drug in 2022, with F2G retaining rights in North America. F2G's last fundraising was in a $70 million round led by Forbion and Sofinnova two years ago.
