Source – F2G
After the FDA declared it was unable to approve its Olorofim candidate, F2G’s quest to break a two-decade dearth in innovative medicines for invasive fungal infections has met a roadblock.
The US regulator informed the firm in a complete response letter (CRL) that it needed more information and analysis in order to finish the evaluation within the time permitted, which was set to expire .
F2G said that the FDA had still urged it to collaborate with the organization on improving the drug’s data and resubmitting its marketing proposal.
Invasive aspergillosis, scedosporiosis, lomentosporiosis, fusariosis, scopulariopsis, and coccidioidomycosis were among the systemic fungal infections studied in the main clinical trial supporting olorofim, which has since been completed and will support a revised application. How long it could take to prepare has not been specified by F2G.
At day 42, 44% of patients had either a full or partial response, according to preliminary study data from 100 patients presented at IDWeek 2022 in October. The overall response rate was 69% when patients with stable illness were taken into account.
When the existing arsenal of azoles, echinocandins, and polyene-based medications fail to treat significant fungal infections, Olorofim (F901318) is the first member of a new family of orotomide antifungal drugs.
Although resistant infections are still uncommon, they have been increasing in frequency as some of the available medications have lost their efficacy. In particular, azoles, which are also used in agriculture, have shown a rise in resistance.
The FDA gave F2G a breakthrough designation for olorofim in 2019, acknowledging the need for novel treatments. Shionogi, a Japanese company, joined the project last year and made an upfront payment of $100 million to license the drug’s rights in Europe and Asia while keeping North American rights with F2G.
“While F2G is disappointed with this outcome, we remain optimistic about olorofim’s potential to address an unmet need for patients with invasive fungal infections who have exhausted their treatment alternatives. We are assessing the details of the CRL and we plan to meet with the FDA to discuss it further, but we are confident that we can identify a regulatory path forward in the US.”
– Francesco Maria Lavino, chief executive officer of F2G
In addition to the Phase II b research, F2G and Shionogi are also conducting the OASIS Phase III trial, in which Olorofim is being contrasted with Astellas’ AmBiome (liposomal amphotericin B), a common treatment for resistant fungal infections, in cases of invasive aspergillosis. The study’s findings are expected next year.