F2G Secures $100M Funding for Second Attempt at FDA Approval for Novel Antifungal Drug Olorofim

Funding:
F2G has raised $100 million in funding to support its second attempt at getting its novel antifungal drug, olorofim, approved by the FDA.

Previous Attempt:
The first attempt was derailed by the FDA, which issued a Complete Response Letter (CRL) in June 2023, prompting F2G to prepare for a resubmission with additional data from its Phase 2b study.

Olorofim:
Olorofim is a member of the orotomide antifungal class, targeting fungal dihydroorotate dehydrogenase (DHODH) involved in pyrimidine synthesis. It has broad microbiologic activity against several important invasive molds and has been granted FDA Breakthrough Therapy Designation.

Clinical Development:
Olorofim’s clinical development includes a Phase 3 study (OASIS) comparing olorofim to liposomal amphotericin B (AmBisome) in patients with invasive aspergillosis (IA) whose infection is either refractory to or unsuitable for azole therapy.

Licensing Agreement:
F2G has a licensing agreement with Shionogi, which provided $100 million in upfront payments and could lead to up to $380 million in regulatory and commercial milestones, as well as double-digit sales royalties.