F2G says it will resubmit antifungal to FDA after agency rejects drug

The antifungal-focused biotech F2G has more work to do before it will be able to get its drug for invasive fungal infections approved by US regulators.

Francesco Maria Lavino

On Monday, the Manchester, UK-based biotech said that the FDA had issued a complete response letter for its experimental drug olorofim. The agency “was not able to approve olorofim at this time” and wants more data and analyses before it will act, the company said.

F2G had been pursuing an aggressive path with regulators, submitting the drug based on a partially enrolled, single-arm, open-label mid-stage study. While the agency accepted the application, the data it created weren’t enough for an approval.

“While F2G is disappointed with this outcome, we remain optimistic about olorofim’s potential to address an unmet need for patients with invasive fungal infections who have exhausted their treatment alternatives,” said CEO Francesco Maria Lavino, the former Merck and Cubist Pharmaceuticals executive who joined the company in 2021. The company said it will work with the FDA on a resubmission with more data.

“We are confident that we can identify a regulatory path forward in the US,” Lavino said in the press release.

Like bacteria, fungi can develop resistance to drugs that target them. But in comparison to antibiotics, there are relatively few distinct types of antifungal drugs, according to the US Centers for Disease Control and Prevention. The agency has repeatedly warned about treatment-resistant Candida auris, for example, and when patients develop invasive infections that are resistant to other treatments, they are left with few options.

The Phase II trial has focused on patients with invasive infections caused by Lomentospora prolificans and types of Scedosporium and Aspergillus fungi, according to ClinicalTrials.gov.

F2G is well-financed. It’s partnered with China’s Shionogi, which invested $100 million in the biotech last year, and the companies plan to continue enrolling patients in a Phase III trial, F2G said. That deal was followed by a fundraising in August of $70 million that was meant to advance its clinical work.

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