UK-based biopharmaceutical company F2G today announced a $100 million financing round to advance late-stage development and commercialization of olorofim, a novel oral antifungal therapy for invasive aspergillosis and other invasive fungal infections.
Olorofim is the leading candidate from the orotomide class of antifungals, which work through a different mechanism of action than existing antifungal medications. It's currently being investigated in a phase 2b study in patients who have limited treatment options for rare and difficult-to-treat invasive fungal mold infections such as azole-resistant aspergillosis. Olorofim has received orphan drug status from the European Medicines Agency and the US Food and Drug Administration (FDA) and has been granted Qualified Infectious Disease Product designation by the FDA.
"This is a pivotal period for the company as we conclude the final stages of development and preparation for commercialization of olorofim in the US and elsewhere," F2G CEO Francesco Maria Lavino, MBA, said in a company press release. "If approved, olorofim is expected to be the first of a new class of antifungal agents with a novel, differentiated mechanism of action and will address genuine unmet needs in conditions with high morbidity and mortality."
An 'urgently needed' therapy
The financing round is being led by the AMR Action Fund, which was launched in 2020 with the aim of investing $1 billion to bring new antibiotics and antifungals to the market. AMR Action Fund CEO Henry Skinner, PhD, will join the F2G board of directors.
"For decades, clinicians have relied on a handful of antifungal classes, with few mechanisms of action and significant limitations due to spectrum of activity, drug toxicities, or drug-drug interactions," Skinner said. "These therapies are increasingly failing in patients. We are thrilled to support F2G’s team as they develop this urgently needed therapy and seek regulatory approval."