New drug approved for tests on gout patients
A US drug company has revealed that it has received regulatory approval to start a Phase II trial of its new drug candidate in patients with gout.
Ardea Biosciences revealed that its trial would aim to show that its new treatment was a safe and useful for patients with gout.
The trials will focus on RDEA594, a major metabolite of RDEA806, the company's lead human immunodeficiency virus (HIV) development compound.
It explained that RDEA594 does not have antiviral activity, but that previous studies have indicated that it is the compound that is responsible for the lower uric acid levels seen in patients taking RDEA806.
"The Phase II trial should allow us to confirm RDEA594's activity in the target population of patients with gout using its prodrug, RDEA806," explained Barry Quart, Ardea Biosciences' president.
"Enrolment in the Phase II trial should begin shortly and we are on track to initiate a Phase I trial with RDEA594 in the second half of this year."
The Phase II trial will be a randomised, double-blind, dose ranging, efficacy and safety test that will be carried out in academic medical centres in Europe and Canada.
It will evaluate the serum uric acid (sUA) level, pharmacokinetics, safety and tolerability of two different dose regimens of RDEA806 in patients with gout.
A spokesman for the Arthritis Research Campaign said after the recent licensing of a new gout drug, febuxostat, the possibility of another treatment on the horizon was exciting.
Recent related stories:
08 October 2008
01 October 2008
01 October 2008
23 September 2008
19 September 2008
18 September 2008
18 September 2008
RSS feed 