Manchester, England, 6th July 2009 - F2G Limited, the Manchester UK based antifungal drug discovery and development company, today announced the initiation of a Phase I clinical study of FG3622, the company’s lead antifungal drug candidate.
The Phase 1 trial is a randomised, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of FG3622. 100 healthy volunteers will be enrolled in the trial which will evaluate single as well as multiple ascending doses of FG3622 which will be administered orally. This clinical trial is the first-in-human study in the global development of FG3622 and will be conducted in the UK.
FG3622 is the first of a new generation of novel class systemic antifungal agents active by both oral and intravenous administration to enter the clinic. The mechanism of action, discovered by scientists at F2G, involves the selective inhibition of a fungal enzyme and is completely distinct from any other class of marketed antifungal agent. The compound displays highly potent activity against a wide range of clinically significant moulds including the common pathogen Aspergillus fumigatus which is the leading cause of Invasive Aspergillosis, a serious, debilitating disease associated with very high mortality rates despite current therapy options.
The incidence of serious life threatening fungal infections has increased steadily over the last 20 years as a result of an increase in the susceptible immunosuppressed patient population. There is a limited choice of antifungals to treat systemic infections and these are currently represented by only three classes of compound. Resistance is becoming an increasing problem, particularly amongst the azole class. The value of the systemic antifungal market rose to USD 3 billion in 2007 and is forecast to grow substantially in the next 7 years.
Mr Shane Kelly, Chief Executive of F2G said “The progress of the FG3622 program represents a tremendous milestone for our scientists and their approach to antifungal drug discovery. Based on its unique mechanism of action and compelling preclinical data, we are hopeful that FG3622 will offer a major advance in antifungal therapy.”
Dr Anthony Kennedy, Chief Scientific and Development Officer added “The first in man trial is an important step for F2G in the development of FG3622 and will provide us with the data needed to design and expedite clinical studies in patients”. Dr Thomas Tscherning, Partner at BankInvest Biomedical Venture and Chairman of the F2G Board of Directors, commented “This is a significant achievement for F2G, as initiation of this first trial offers F2G the opportunity to demonstrate the broad clinical potential of a new class of antifungal therapeutics. There is a clear clinical need for new agents to treat systemic fungal infections and we believe FG3622 presents a very promising new approach to treating these serious and life-threatening conditions”.
