UK biotech F2G has raised $100 million as it prepares to refile its olorofim candidate for invasive fungal infections, which was turned down last year by the FDA.The Manchester-based company said the new cash will help it to complete the late-stage development of olorofim, a novel oral antifungal for invasive aspergillosis and other serious fungal infections, to support the company during the regulatory review process, and prepare for a commercial launch in the US.F2G's first attempt to win FDA approval for olorofim resulted in a complete response letter (CRL) from the agency saying there was a need for additional data that meant it would be unable to complete its review within the allotted time.The biotech has spent the intervening period running trials to shore up the data on the drug, which it hopes could end a two-decade drought in novel therapies for invasive fungal infections in the US.Olorofim (formerly F901318) is the first in a new class of orotomide antifungal agents intended to provide a new treatment option for serious fungal infections when the current armamentarium of azoles, echinocandins, and polyene-based medicines fail.

英国生物技术公司F2G筹集了一亿美元资金，准备为其侵袭性真菌感染的olorofim候选药物进行补充，该药物去年被FDA拒绝。这家总部位于曼彻斯特的公司表示，新资金将帮助其完成奥洛芬的后期开发，奥洛芬是一种治疗侵袭性曲霉病和其他严重真菌感染的新型口服抗真菌药，在监管审查过程中为该公司提供支持，并为在美国的商业上市做好准备。F2G首次尝试获得FDA对奥洛芬的批准，导致该机构发出了一封完整的回复信（CRL），表示需要更多数据，这意味着它将无法在规定的时间内完成审查。这家生物技术公司在这段时间内进行了试验，以支持该药物的数据，希望能够结束美国侵袭性真菌感染新疗法20年的干旱。奥洛芬（以前称为F901318）是一类新的口服抗真菌剂中的第一种，旨在当目前的唑类、棘白菌素类和多烯类药物失效时，为严重的真菌感染提供新的治疗选择。

The FDA granted F2G a breakthrough designation for olorofim in 2019.Since the first filing, F2G has completed a phase 2b study in patients with invasive aspergillosis, scedosporiosis, lomentosporiosis, fusariosis, scopulariopsosis, and coccidioidomycosis infections and limited treatment options – which was ongoing when the FDA turned down the application in June 2023.It has also started a 225-subject phase 3 trial called OASIS, comparing treatment with olorofim to Astellas' AmBisome (liposomal amphotericin B) in invasive aspergillosis, which should generate results next year.Invasive aspergillosis is a serious infection that typically a.

2019年，美国食品和药物管理局（FDA）授予F2G奥洛芬一项突破性的指定。自首次提交申请以来，F2G已经完成了侵袭性曲霉病，scedosporiosis，lomentosporiosis，fusariosis，scopulariopsosis和球孢子菌病感染患者的2b期研究，并且治疗选择有限-当美国食品和药物管理局（FDA）于2023年6月拒绝该申请时，该研究正在进行中。它还启动了一项名为OASIS的225名受试者的3期试验，将奥洛芬与Astellas的AmBisome（脂质体两性霉素B）治疗侵袭性曲霉病进行比较，预计明年会产生结果。侵袭性曲霉病是一种严重的感染，通常是a。