MANCHESTER, United Kingdom, Jan. 05, 2023 (GLOBE NEWSWIRE) — F2G Ltd. today announced that the Company’s chief executive officer, Francesco Lavino will provide a corporate overview at Biotech Showcase™ 2023 taking place in San Francisco, California, from January 9-11, 2023.
Francesco Maria Lavino will discuss the Company’s lead antifungal drug candidate, olorofim, a first-in-class, oral small molecule with a novel, differentiated mechanism of action for the treatment of invasive fungal infections. Last month, the U.S. Food and Drug Administration (FDA) accepted for filing a New Drug Application (NDA) for olorofim for the treatment of invasive fungal infections in patients who have limited or no treatment options with a PDUFA date set for June 17, 2023.
Details for the presentation are as follows:
Date: Wednesday, January 11, 2023
Time: 10:00 a.m. PT
Location: Yosemite-C, Ballroom Level, Hilton San Francisco Union Square
Olorofim (formerly, F901318) is F2G’s leading candidate from the orotomide class and the company recently completed enrollment of an ongoing Phase 2b open-label study in patients who have limited treatment options for difficult-to-treat, invasive, rare fungal mold infections including azole-resistant aspergillosis, scedosporiosis, lomentosporiosis, invasive Scopulariopsis, and other rare mold infections (NCT03583164). Initial data were presented at ID Week in Washington DC in October 2022 and the full data will be presented at a global conference later this year. A global Phase 3 trial (“OASIS”) to compare treatment with olorofim versus AmBisome® followed by standard of care (SOC) in patients with proven or probable invasive fungal infection due to Aspergillus species (NCT05101187) is currently enrolling. Olorofim has received orphan drug designation from the FDA for the treatment of coccidioidomycosis, scedosporiosis (including lomentosporiosis), invasive Scopulariopsis, and invasive aspergillosis. Olorofim has also received orphan drug designation from the European Medicines Agency (EMA) for the treatment of invasive aspergillosis, invasive scedosporiosis (including lomentosporiosis), and invasive Scopulariopsis. Olorofim has been granted Qualified Infectious Disease Product (QIDP) designation for invasive aspergillosis, invasive scedosporiosis, invasive lomentosporiosis, coccidioidomycosis, invasive disease due to Scopulariopsis species, and invasive fusariosis. Olorofim has received Breakthrough Therapy Designation for both “treatment of invasive mold infections in patients with limited or no treatment options, including aspergillosis refractory or intolerant to currently available therapy, and infections due to Lomentospora prolificans, Scedosporium, and Scopulariopsis species” and “treatment of Central Nervous System (CNS) coccidioidomycosis refractory or otherwise unable to be treated with standard of care therapy.” Olorofim is not approved by the FDA or any other regulatory agency.
F2G is a biotech company with operations in the UK, US, and Austria focused on the discovery and development of novel therapies to treat potentially life-threatening invasive fungal infections. F2G has discovered and developed a completely new class of antifungal agents called the orotomides which selectively target a key enzyme in the de novo pyrimidine biosynthesis pathway. This is a completely different mechanism from that of the currently marketed antifungal agents and gives the orotomides fungicidal activity against a broad range of rare and resistant fungal mold infections. For more information, please visit: www.f2g.com
This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also, for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.
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