July 4, 2008
Movetis Advances Cirrhosis Drug to Phase IIb Trial
Movetis has announced that M0002 is progressing to Phase IIb following positive results of a Phase IIa multiple-dosing trial for the treatment of ascites.
The randomized, double blind, placebo controlled, dose-titration study explored the safety, tolerability, pharmacokinetic profile and efficacy of M0002 in cirrhotic subjects with ascites and hypo- or normonatraemia. It was conducted in Belgium at multiple centers and enrolled 15 patients who were treated once daily with drug or placebo for 15 days.
Although a small number of patients were included in the study, a trend towards more stabilized and normalized plasma sodium levels was seen in those treated with M0002.
M0002 is an orally-active selective vasopressin 2 receptor antagonist and a member of a new class of compounds, known as aquaretics, which inhibit water reabsorption from the renal collecting duct.
Ascites is the accumulation of fluid in the abdomen in patients with liver cirrhosis resulting from liver conditions such as hepatitis C, hepatitis B or alcoholism.
Remi Broeck, chief development officer of Movetis, said: "We are delighted with the promising results from the dose-titration trial. We will begin patient recruitment shortly for a Phase IIb dose-finding study."