The UK company F2G Ltd. has announced a strategic collaboration with Japanese pharmaceutical company Shionogi & Co. Ltd. to develop and commercialize olorofim, an antifungal treatment for invasive fungal infections, in Europe and Asia.
The deal centers on olorofim, F2G’s oral antifungal therapy for the treatment of invasive aspergillosis, an infection that can be deadly for people with weakened immune systems. A spokesperson for F2G told us the collaboration covers China, Japan, Australia, and other major markets.
Under the terms of the agreement, Shionogi will conduct the clinical trials and subsequent registration and commercialization of olorofim for invasive aspergillosis in Europe and Asia. Shionogi will make an upfront payment to F2G of $100M and share development costs in global studies. F2G will also be eligible to receive additional regulatory and commercial milestones of up to $380M, as well as double-digit royalties on net sales.
“By joining forces with Shionogi, F2G will be able to progress the development of olorofim with a partner that has a proven track record in global drug and business development,” F2G’s spokesperson said.
“This will further enable F2G to focus on its strategy to develop and commercialize olorofim in the US, and bring this potentially life-saving therapy to more patients all over the world.”
Increases in cancer cases, organ transplants, and the use of drugs, including broad spectrum antibiotics, has led to an increase in fungal infections, which can be particularly difficult to treat. Fungi are also a major issue in respiratory conditions such as asthma, chronic obstructive pulmonary disease (COPD), and bronchiectasis. Also, it has been estimated that coronavirus disease–associated pulmonary aspergillosis (CAPA) affects about 20% to 30% of severely ill, mechanically ventilated patients with Covid-19.
Because of these infections, the use of antifungal drugs is set to increase. According to Allied Market Research, the global antifungal drugs market was valued at $16.6B in 2020, and is projected to reach $25B by 2030.
F2G focuses on the development of therapies to treat life-threatening invasive fungal infections. In 2015, the company discovered and developed a new class of antifungal agents called orotomides, one of which is olorofim. These compounds treat fungal infections by preventing the growth of hyphae – the filaments of the fungus responsible for, among other things, nutrition.
F2G is currently close to completing a large phase IIb open-label trial and has initiated a phase III randomized control trial, with eyes on a 2023 launch in the US.
“The phase III trial is a global study across the US, EU, and Asian countries. F2G is preparing to file an NDA with the FDA this year and plans to launch olorofim in the US in 2023 (pending FDA approval). We have been granted Breakthrough Therapy Designations for olorofim by the FDA in two indications, based on initial efficacy and safety data. Olorofim has also received orphan drug status from the FDA together with Qualified Infectious Disease Product (QIDP) designation,” said the company.
Francesco Maria Lavino, F2G’s CEO, said the collaboration with Shionogi would allow F2G to concentrate on the development and commercialization of olorofim for the US market.
Innovation in the development of new antifungals has been slow, and there are only a few biotech companies addressing the issue. As well as F2G, other players include US company Scynexis, which had its drug ibrexafungerp approved by the FDA in 2021 to treat the infection vulvovangial candidiasis; California-based Cidara Therapeutics, which is testing a treatment for candidiasis; and New York’s Amplyx Pharmaceuticals, which developed a drug that targets the fungal cell wall and has shown broad efficacy in trials, including against Candida.
Cover image via Shutterstock