F2G to Present Interim Results from Phase 2B Open Label Study of Olorofim in Invasive Fungal Infections at IDWeek 2022

MANCHESTER, United Kingdom, Oct. 13, 2022 (GLOBE NEWSWIRE) — F2G Ltd, a clinical-stage biopharmaceutical company focused on the discovery and development of novel therapies to treat life-threatening rare fungal infections with a high unmet medical need, today announced that it will present new clinical data in three oral presentations and two poster presentations at IDWeek 2022, to be held in Washington, D.C. from October 19-23, 2022.

Oral presentations will include the first presentation of efficacy and safety data from the Phase 2B trial of ofolorofim (ClinicalTrials.gov Identifier: NCT03583164) the company’s novel orotomide antifungal, active against Aspergillus (including azole-resistant and cryptic species), resistant molds (e.g., Lomentospora prolificans, Scopulariopsis) and dimorphic fungi (e.g., Coccidioides). The Company will also present posters on pharmacokinetic data from Phase 1 and Phase 2B studies of olorofim antifungal therapy.

Oral Presentation Details:

Presentation Title: Olorofim for treatment of invasive fungal infections (IFI) due to moulds in patients with limited or no treatment options: Interim results from a Phase 2b open-label study (NCT03583164, Study 32)
Presentation Number: 754
Session: Medical Mycology
Presenting Author: Johan A. Maertens, M.D., Ph.D., Professor of Internal Medicine and Hematology, Acute Leukemia and Transplantation Unit at University Hospitals Leuven; Department of Microbiology, Immunology and Transplantation at KULeuven, Leuven, Belgium
Presentation Date and Time: Thursday October 20, 2022; 2:30-2:45 PM ET

Presentation Title: Olorofim for the treatment of invasive mould infections in patients with limited or no treatment options: Comparison of interim results from a Phase 2B open-label study with outcomes in historical control populations (NCT03583164, FORMULA-OLS, Study 32)
Presentation Number: 870
Session: Antifungal Clinical Trials & PK/PD Studies
Presenting Author: Johan A. Maertens, M.D., Ph.D., Professor of Internal Medicine and Hematology, Acute Leukemia and Transplantation Unit at University Hospitals Leuven; Department of Microbiology, Immunology and Transplantation at KULeuven, Leuven, Belgium
Presentation Date and Time: Friday October 21, 2022; 11:00-11:15 AM ET

Presentation Title: Olorofim – the first of a novel class of antifungals, the orotomides; F2G Inc.
Presentation Number: 1618
Session: New Antimicrobials and ID Diagnostics in the Pipeline – Fungal
Presenting Author: John H. Rex, M.D., Chief Medical Officer, F2G
Presentation Date and Time: Saturday October 22, 2022; 8:20-8:30 AM ET

Poster Presentation Details:

Presentation Title: An Open-Label Study in Healthy Volunteers to Determine the Absolute Bioavailability of the Effect of Food and Dosing by Nasogastric Tube upon the Pharmacokinetics of a Single Oral Dose of Olorofim (OLO)
Poster Number: 594
Session: PK/PD Studies
Presenting Author: Karen Cornelissen, PhD, Senior Director, Early Clinical Development, F2G

Presentation Title: Olorofim (OLO) for treatment of invasive mould infections in patients with limited or no treatment options: PK data from a Phase 2b open-label study (NCT03583164, Study 32)
Poster Number: 595
Session: PK/PD Studies
Presenting Author: Karen Cornelissen, PhD, Senior Director, Early Clinical Development, F2G

About F2G
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

About Olorofim
Olorofim (formerly, F901318) is F2G’s leading candidate from the orotomide class and is currently in a Phase 2b open-label study (ClinicalTrials.gov Identifier: NCT03583164) in patients who have limited treatment options for difficult-to-treat invasive, rare fungal mold infections such as azole-resistant aspergillosis, scedosporiosis, lomentosporiosis, and other rare mold infections. F2G has initiated a global Phase 3 trial (“OASIS”)2 to compare treatment with olorofim versus AmBisome® followed by standard of care (SOC) in patients with lower respiratory tract invasive fungal disease caused by proven or probable infection with Aspergillus species. Olorofim has received orphan drug status from the European Medicines Agency for the treatment of invasive aspergillosis and invasive scedosporiosis. Olorofim has also received orphan drug status from the FDA for the treatment of coccidioidomycosis scedosporiosis, and invasive aspergillosis. 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.

About Invasive Aspergillosis
Aspergillosis is a fungal infection caused by Aspergillus species of mold which are commonly found all over the world. Most of these molds, in most people, are harmless. However, aspergillus is transmitted to humans through inhalation and may cause a broad spectrum of disease ranging from hypersensitivity reactions to direct invasion and destruction of tissue. Invasive aspergillosis is a rare disease that can occur in over 10% of some high-risk immunosuppressed populations with mortality exceeding 80%.

Kara Stephens-Weaver
LifeSci Communications
407-765-1185
KStephens-Weaver@LifeSciComms.com