F2G secures $100M for antifungal drug FDA return

U.K.-based biotechnology firm F2G has successfully raised $100 million to finalize the late-stage trials of a novel antifungal treatment and seek U.S. regulatory approval following a previous rejection last year. The AMR Action Fund, a public-private consortium focused on accelerating antimicrobial drug development, co-led the funding round with ICG, along with eight additional investors.

F2G is developing a drug known as olorofim for the treatment of invasive aspergillosis, a severe fungal infection caused by the Aspergillus mold. This condition primarily affects individuals with weakened immune systems and can be deadly. Currently, a Phase 3 clinical trial for olorofim is underway.

Invasive aspergillosis typically starts in the lungs and can spread to other body parts. It poses a significant challenge due to the increasing issues of antimicrobial resistance and the limited efficacy of existing antifungal treatments. Henry Skinner, CEO of the AMR Action Fund, emphasized the urgent need for innovation in antifungal treatments, noting the disproportionate impact fungal infections have on vulnerable populations. Skinner will also join F2G's board of directors alongside Toby Sykes, managing director of ICG Life Sciences.

Olorofim represents a new class of antifungal agents called orotomides, which function by disrupting a crucial enzyme in the fungal cells. The FDA had previously granted olorofim a Breakthrough Therapy designation in 2019, and F2G had submitted the drug for approval based on encouraging data from a Phase 2b study involving the first 100 patients. However, the FDA requested additional data, which F2G aims to provide through the ongoing Phase 3 trial.

F2G's Chief Financial Officer Ralf Schmid expressed confidence in the drug's potential and the company's ability to meet the FDA's requirements, viewing the recent capital influx as a testament to olorofim's promise. The company remains optimistic about addressing the FDA's concerns and advancing the drug towards market approval.

The Phase 3 study compares olorofim with an established antifungal treatment, AmBisome. Besides funding the clinical trials, the $100 million will also support preparations for the U.S. launch of olorofim, pending regulatory approval. 

F2G has also entered into a partnership with Japan-based pharmaceutical firm Shionogi for its operations in Europe and Asia. The funding round saw participation from notable investors including Novo Holdings, Forbion, Advent Life Sciences, Blue Owl Healthcare Opportunities, Sofinnova Partners, Brace Pharmaceuticals, Merifin Capital, and Morningside Ventures. The funding is expected to be finalized in the fourth quarter of the year.

This significant financial backing highlights the importance and potential of developing new treatments for serious fungal infections, addressing both a critical medical need and the growing issue of antimicrobial resistance.

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