F2G has raised $60.8 million to fund late-phase clinical development of its antifungal agent olorofim and prepare for commercialization. The Cowen Healthcare Investments-led round comes four years after F2G raised a similar sum to take the dihydroorotate dehydrogenase inhibitor into phase 2b.
The treatment of fungal infections last took a major step forward in the early 2000s when the FDA approved Merck’s Cancidas, the first drug in a new class of antifungals known as echinocandins. Since then, physicians have had to try to treat fungal infections using the same core therapeutic toolkit, which features three major classes of drugs, including echinocandins.
F2G wants to add to the toolkit. Olorofim, also known as F901318, is part of a new class of antifungal drugs, the orotomides. The drug inhibits the dihydroorotate dehydrogenase enzyme to disrupt the synthesis of pyrimidines, compounds that are essential to fungi.
The prospect of F2G establishing a new class of antifungal products has persuaded Cowen to lead a $60.8 million investment with the support of existing investors including Novo Holdings, Morningside Ventures, Brace Pharma Capital and Advent Life Sciences. Most of the existing investors participated in F2G’s 2016 raise, while Morningstar provided money to the biotech in 2019.
F2G used the previous financings to start an open-label phase 2b trial of olorofim in the treatment of invasive fungal infections in patients with limited treatment options. The 100-subject trial is designed to show whether olorofim can treat illnesses such as azole-resistant aspergillosis, scedosporiosis, lomentosporiosis and other rare mold infections.
The study began in 2018 and has a primary completion date of December 2020 on ClinicalTrials.gov. With a phase 2b data drop in sight, F2G has raised the additional capital to fund late-phase work and scale up its organization in anticipation of the approval and commercialization of olorofim.
If F2G brings olorofim to market, it will serve a population that lacks many other options. Astellas and Pfizer brought antifungal agent Cresemba to market in 2015, wracking up sales of $190 million in the year up to September 2019, but F2G’s trial is targeting patients with fungi that are resistant to such azoles.