Novo-backed $61m fundraising helps F2G prep for antifungal launch

Anglo-Austrian biotech F2G has raised $60.8 million in venture financing to help it bring a drug for life-threatening fungal infections through late-stage development and onto the market.

While these infections remain fairly rare, there is still a pressing need for new antifungals to provide treatment options when established therapies fail, and F2G is one of only a small number of companies working on new antifungal drug development.

The current armamentarium of azoles, echinocandins and polyene-based medicines sometimes lack efficacy and have dosing and tolerability issues. Meanwhile, rising levels of resistance to some of these drugs among fungal pathogens – particularly azoles – is on the rise because they are also used in agriculture.

F2G will use the cash injections from new and existing investors to fund registration trials of olorofim (F901318), the first in a new class of orotomide antifungal agents – as well as to prepare for marketing applications and commercialisation.

Orotomides target the fungal enzyme dihydroorotate dehydrogenase (DHODH), a different mechanism from that of the currently marketed therapies giving them fungicidal activity against a broad range of rare and resistant infections, according to F2G.

Olorofim is currently in a phase 2b trial looking at its potential to treat systemic fungal infections such as invasive aspergillosis, scedosporiosis, lomentosporiosis, fusariosis, scopulariopsosis, and coccidioidomycosis in patients who don’t have other treatment options. Data from that study is due around the end of this year or in early 2021.

The biotech claimed a breakthrough designation from the FDA last year for olorofilm, and says its drug is the only antifungal agent ever to have been awarded this status based on early tolerability and efficacy data, and that could lead to an accelerated review from the US regulator.

It also has orphan status as a treatment for coccidioidomycosis – also known as Valley Fever – a rare infection seen in US states like California and Arizona that is caused by inhaling dust laden with spores. The disease seems to be on the increase, for reasons that aren’t clear.

Meanwhile, there are also reports that invasive fungal infections like aspergillosis are being seen in some COVID-19 patients on ventilators.

The company is being incubated by Novo Nordisk’s venture capital arm Novo Ventures, and following the new financing round one of Novo Ventures’ partners – Naveed Siddiqi – has joined F2G’s board of directors in place of Martin Edwards, who is retiring.

If approved, olorofim could be the first drug in a new antifungal class in almost two decades, according to Novo Ventures, and “represents a very significant market opportunity in excess of $6 billion, in an area of high unmet clinical need.”

Novo was joined by Cowen Healthcare in the latest funding round, along with existing investors Morningside Ventures, Brace Pharma Capital and Advent Life Sciences.