UK-based biotech F2G was dealt a blow as the US’ FDA issued a complete response letter rejecting its latest new drug application (NDA).

The company was seeking approval for Olorofim, an investigational antifungal intended to treat invasive fungal infections in patients with limited treatment options.

F2G claimed in a June statement that the FDA requested additional data and analysis that extended beyond the current review period.

Going forward, F2G is continuing clinical development for Olorofim alongside partners Shionogi & Co, who have commercial responsibility for the drug in Europe and Asia Pacific. It plans to work with the FDA to plan new analyses and further develop a new application package.

Data presented was drawn from the first 100 patients enrolled in F2G’s Phase IIb, single-arm, open-label trial (NCT03583164). The study was designed to explore the efficacy of Olorofim against difficult-to-treat invasive, rare fungal mould infections such as azole-resistant aspergillosis, scedosporiosis and lomentosporiosis among others.

F2G is planning to resubmit with improved data, drawn from its recently initiated Phase III OASIS trial (NCT05101187). It is currently enrolling patients to compare Olorofim versus AmBisome followed by standard of care, against Apsergillus fungal infections.

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F2G chief executive officer Francesco Maria Lavino expressed disappointment but remained optimistic, saying: “We are confident that we can identify a regulatory path forward in the US.”

According to F2G, the FDA and EMA granted Olorofim orphan drug designation for treating a variety of fungal infections. It has already received breakthrough therapy and qualified infectious disease product designations. Despite this, it is yet to receive approval from any regulatory body.

Earlier this year, F2G received Bionow’s 2022 Investment Deal of the Year Award for its collaboration with Shionogi to develop antifungals.

This content was updated on 25 January 2024