Improving the effectiveness of inhaled medicines
FV-100 is a brand new anti-viral drug that aims to bring relief to millions of shingle sufferers from around the world.
Over two million people around the world are affected byshingles on an annual basis. But now a new, powerful, antiviral agent has beendeveloped, in part, by Cardiff University researchers.
A new discovery
In the mid-1990s, researchers led byProfessor Chris McGuigan at Cardiff University discovered an entirely newfamily of antivirals - the bicyclic nucleoside analogues (BCNAs). Working in conjunction with Professor IanBalzarini from the Rega Institute of Katholieke Universiteit Leuven, Belgium,the team conducted virology tests on these new antivirals. They found that the alkyl BCNAs to be potentand selective agents active against the Varicella Zoster Virus (VZV) - thecause of human chickenpox and shingles.
The molecules synthesised in Professor McGuigan'sBCNA research programme represented completely new chemical entities with an initial 'hit molecule' being around 250-times more powerful in vitro than the first-line drugs against VZV,acyclovir and its valyl ester (Valtrex).
Subsequent work to generate second generation aryl BCNAsrevealed that the lead candidate, Cf1743, was the most potent inhibitor of VZVever discovered - roughly 10,000-times more active than acyclovir in vitro.
Cardiff University took the lead to exploit the potent anti-VZV BCNAagents and licensed the patents to Fermavir Pharmaceuticals who worked with the research team to develop FV-100 as a novelorally bioavailable pro-drug. This research and development washighly collaborative with Professor McGuigan carrying out drug design andsynthesis, Professor Balzarini performing the antiviral assay and various contractresearch organisations undertaking pre-clinical regulatory work.
Pre-clinical research and development onFV-100 was completed in 2007 and the agent entered phase one clinical trials in2008.
Shingles, also known as herpes zoster, is an infection of a nerve and the skin around it. It is caused by the varicella-zoster virus, which also causes chickenpox.
Commercial success
The development of anti-VZV BCNAs has been driven by major financial investment from the commercial pharmaceutical sector, realised through three acquisition deals related to FV-100 assets and highly skilled jobs in Cardiff and internationally.
A combination of promising outcomes in human clinical trials, and the effective collaborative research partnership between the research team and Fermavir, led to the US pharmaceutical company Inhibitex Inc. to acquire Fermavir in 2007. As FV-100 was Fermavir's only main drug asset, the purchase of the company placed a direct market valuation on the antiviral agent - more than $19M.
The success of further clinical trials contributed to the acquisition of Inhibitex by Bristol-Myers Squibb (BMS) and later by Synergy Pharmaceuticals (New York), a NASDAQ listed company currently valued at $400M.
There are plans for a FV-100 registration trial for 2014, bringing hope to the millions of shingle sufferers around the world.