The Rare Fungal Disease Company

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Overview

F2G is a world-leading UK, US and Austria based Biotech company focused on the discovery and development of novel therapies to treat life-threatening invasive fungal infections. Our goal is to bring to market novel antifungal agents which are differentiated from the existing agents in terms of mechanism of action. Globally, there is an unmet medical need for therapies that are active against resistant infections and also against pathogens which have been difficult to treat historically.

About Us

F2G is a clinical-stage biopharmaceutical company focused on the discovery and development of novel therapies to treat life-threatening invasive fungal infections. F2G has discovered and developed a completely new class of antifungal agents called the orotomides. The orotomides have a distinct mechanism of action, selectively targeting fungal dihydroorotate dehydrogenase (DHODH), a key enzyme in the de novo pyrimidine biosynthesis pathway. This differentiates the orotomides from the currently marketed antifungal agents. Olorofim (formerly F901318) is F2G’s leading candidate from this class and has fungicidal activity against a broad range of mould infections including a variety of rare and resistant moulds that cause life-threatening infections for which current therapies have limitations or are ineffective. Olorofim is in a Phase 2b open-label study focusing on rare and resistant invasive fungal infections including invasive aspergillosis (including azole-resistant strains), coccidioidomycosis and scedosporiosis (including lomentosporiosis). Olorofim has received orphan drug status from the European Medicines Agency and orphan drug status, Qualified Infectious Disease Product (QIDP) designation and Breakthrough Therapy designation from FDA. F2G is headquartered in the UK with subsidiaries in the US and Austria.

Antifungal Market

The world market for antifungal agents is currently worth in excess of US$6 billion with consistent annual growth driven by year-on-year increases in the susceptible immune compromised patient population. Increases in cancer, organ transplants and use of potent drugs, including broad spectrum antibiotics has led to significant increases in fungal infections. Fungi are now recognised as a major issue in several respiratory conditions, being responsible for exacerbations of symptoms in asthma, COPD and bronchiectasis patients. This is likely to increase the use of antifungal drugs over the coming years.

There are only three major drug classes; triazoles, polyenes and echinocandins plus flucytosine. The polyenes have been available for over 50 years and the introduction of amphotericin B in the 1960’s radically changed the survival hopes of patients with serious fungal infections. The azoles brought the possibility of oral treatment and have shown better tolerability overall than the polyenes. The echinocandins are the latest class of agent to be introduced to the market, but there has not been a new class of agents for over 15 years.

Crude mortality remains high amongst haemato-oncology and intensive care patients and increasing resistance is being seen amongst Candida and Aspergillus species. The mechanisms for this may be partly due to overuse of antifungals, but with Aspergillus species two main mechanisms have been identified; one is chronic use in respiratory patients where it is almost impossible to clear the infection, and the second is acquisition of strains which have developed resistance due to the use of azoles in agriculture. Other rare moulds such as the Zygomycetes, Scedosporium and Lomentosporum species are also becoming more prevalent, are challenging to differentiate from aspergillosis and can be difficult to treat.

Other pathogens such as Coccidioides species are endemic to particular parts of the world and can be contracted by otherwise healthy individuals, causing chronic debilitating disease. Olorofim has activity in vitro and in animal models, against a wide range of endemic mycoses, including Coccidioides species and may offer an alternative to the currently-available agents.

F2G believes that its novel agent, olorofim, and subsequent agents, will address some of the many challenges which face the treating physician and the patient with invasive fungal infections.

Continuing Medical Education

Click below to access the CME programmes being supported by F2G.

CME Programmes

Useful Links

Careers

F2G is staffed by highly motivated scientists and physicians. When recruiting we look for candidates with a science background, integrity and excellent interpersonal and organisational skills. We embrace diversity.

Since our culture is one of expected achievement driven by our passion for what we do, we are looking for individuals who thrive on working in a team-oriented environment but are also self-motivated and can work independently. It is through individual talents that we make F2G successful.

Pipeline

¹FDA submission under breakthrough therapy designation based on efficacy and safety data for the first 100 patients enrolled in the trial.
²For use in chronic pulmonary mold infections, including pulmonary aspergillosis.

We also are leveraging our expertise in fungal molecular biology and biochemistry and our deep understanding of the new orotomide class of antifungal agents that we discovered to identify and develop additional novel antifungal compounds.

Access to Olorofim, including Expanded Access (Compassionate Use)

F2G is aware that when there are limited treatment options available for life-threatening medical conditions, patients or their doctors may request treatment with an investigational drug on a Compassionate Use or an Expanded Access basis. While we recognise this applies to patients with rare and difficult-to-treat mould infections, our lead compound, olorofim, is currently at an early stage of clinical development and its safety and effectiveness are still being carefully evaluated in clinical trials. read more

Publication and Authorship Policy

PURPOSE AND SCOPE
The purpose of this Policy is to lay out the criteria for deciding authorship of clinical and non-clinical research which has been organised and funded by F2G (i.e. where F2G is the sponsor of the study and takes legal and regulatory responsibility) as well as decisions on which journals to submit research papers to. It also establishes the framework for publication of research with both a positive and negative outcome as well as defining criteria for any payments which may be made and to whom. read more