F2G secures $100M for second try at launching new antifungal class

F2G, a U.K.-based biotech company, is making strides toward bringing a new class of antifungal medication, olorofim, to market. After an initial setback with the U.S. Food and Drug Administration (FDA), the company has now secured $100 million in funding to advance its efforts for commercialization in the next year.

Olorofim belongs to a novel category of antifungal drugs known as orotomides, which target the dihydroorotate dehydrogenase enzyme. By inhibiting this enzyme, olorofim disrupts the synthesis of pyrimidines, compounds critical to fungal cells. Although F2G had previously applied for FDA approval, the agency requested additional data and analyses in June 2023 before reconsidering the request. 

The recent influx of $100 million, acquired through a series H funding round, will enable F2G to finalize the late-stage development of olorofim, specifically for treating invasive aspergillosis. Additionally, the funds will support the pursuit of regulatory approval and the preparation for U.S. commercialization. The funding round was co-led by AMR Action Fund—a collaborative initiative involving the World Health Organization and various pharmaceutical companies—and Intermediate Capital Group. Existing investors such as Novo Holdings, Advent Life Sciences, Sofinnova Partners, Forbion, Blue Owl, Morningside Ventures, Brace Pharmaceuticals, and Merifin Capital also participated.

A spokesperson for F2G noted that the company has had several productive meetings with the FDA, resulting in an aligned plan for resubmission of their approval application. The resubmission will utilize existing data from a phase 2b study, which initially included 100 patients suffering from various invasive fungal infections caused by resistant fungi. The updated application will incorporate data from all 200 participants in the trial. Although no new data generation is required, the process will take some time to gather and organize the historical control data for submission. The company aims to submit this updated data by the end of the next year.

F2G’s CEO, Francesco Maria Lavino, expressed his excitement about the new investment, emphasizing the importance of collaboration with AMR Action Fund and Intermediate Capital Group. He described this phase as crucial for the company as they conclude the final stages of development and move towards commercialization. Lavino also highlighted that if approved, olorofim would be the first in its class with a unique mechanism of action, addressing significant unmet needs in treating severe fungal conditions with high morbidity and mortality rates.

In addition to the phase 2b study, F2G is currently conducting a phase 3 study that compares olorofim with AmBisome, an already approved antifungal treatment, specifically for invasive aspergillus. This ongoing research further underscores the potential of olorofim to become a groundbreaking treatment option in the field of antifungal medications.

F2G’s journey towards getting olorofim approved and commercialized highlights the challenges and perseverance often required in drug development. Despite initial obstacles, the company’s ability to secure substantial funding and align strategically with regulatory bodies places it in a promising position to bring a much-needed antifungal treatment to market.

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