Anti-Hepatitis C drug INX-189 successfully completes phase 1a trial in humans
1 September 2010
Inhibitex, the US biopharmaceutical company, which is working on potential anti-viral drugs with Prof Chris McGuigan’s laboratory in the Welsh School of Pharmacy, has just announced the successful conclusion of the initial phase 1a trials of INX-189 in humans.
This drug, first synthesised less than two years ago in the laboratory in the Welsh School of Pharmacy, is active against Hepatitis C.. This disease affects some 170 million individuals worldwide (3% of the human population) and current treatment is unsatisfactory.
In this trial, 42 healthy volunteers received either a single oral dose of INX-189, ranging from 3 mg to 100 mg, or placebo. The Company plans to present detailed results from this trial during a future scientific meeting. Preliminary data from the trial are as follows:
- INX-189 was generally well tolerated at all dose levels;
- No drug-related serious adverse events;
- No dose-related trends in frequency or type of adverse events; adverse events occurring in more than one subject were headache and nasal congestion;
- No grade II or higher laboratory abnormality adverse events or clinically significant changes in ECGs; and
- Pharmacokinetic data supports INX-189’s potential for once daily (QD) dosing.
Cardiff Team at Inhibitex HQ in Georgia (Spring 2010)
l-r Dr Mohamed Aljarah, Karoline Madela, Prof Chris McGuigan
Professor McGuigan,. who is also a member of the Board of Directors of Inhibitex, warmly welcomed this news, saying: "These early clinical data on INX-189 are highly encouraging; we now know that the drug is safe in a single dose that exceeds the dose we expect to be effective in patients. Multiple dose studies in patients are now necessary, and should progress before the end of 2010. INX-189 is well on track to become a much needed potential new drug for hepatitis C infection".
(For a recent scientific paper describing the development of INX-189 see
C. McGuigan, A. Gilles, K. Madela, M. Aljarah, et al.
J. Med. Chem., 2010, 4949-4957.)
A current Powerpoint presentation from Prof McGuigan describing Pro Tides is available here. )
See also
Second anti-viral Drug discovered by Prof McGuigan’s group enters human clinical trials
..
Prof Chris McGuigan
